Yourlawyer.com (Botox News)

Botox Maker Sues to Have Off-Label Marketing Rules Lifted

Fri, 02 Oct 2009 00:00:00 -0700

Allergan Inc. is claiming that rules forbidding it from distributing information about the off-label use of Botox wrinkle treatment and other drugs are a violation of its First Amendment right to free speech. According to The Wall Street Journal, the drug maker has filed suit against the Food & Drug Administration (FDA) over the restrictions.

Using a drug in a way that has not been approved by the FDA is known as off-label use. As we've reported in the past, doctors are free to prescribe off-label, but the Food, Drug and Cosmetic Act of 1938 prohibits drug makers from promoting such uses. According to The Wall Street Journal, they may provide doctors with accurate information about off-label uses - such as scientific studies - if a doctor requests such material.

Critics of off-label promotion say such marketing practices are harmful, as the vast majority of off-label uses have not been subjected to enough scientific scrutiny to ensure their safety. Even so, off-label prescribing is common. According to The Wall Street Journal, a 2006 study in the Archives of Internal Medicine found that 21% of drug use is off-label.

When drug makers do promote off-label uses, they can get in a lot of trouble. For example, last month we reported that Pfizer had agreed to a $2.3 billion settlement with the U.S. Department of Justice to resolve allegations that it had illegally marketed several drugs including the antipsychotic Geodone, the pain killer Bextra; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug. That agreement marked the largest healthcare fraud settlement in the history of the U.S. Department of Justice.

Allergan's Botox is approved to treat facial wrinkles, eye muscle disorders and excessive underarm sweating. According to Reuters, Allergan is currently testing Botox for a variety of uses including treatment for upper limb spasticity in stroke victims as well as for migraine headaches.

In April, the FDA mandated a boxed warning for Botox and other botulinum toxin injection treatments regarding the risk of adverse events when the effects of the drugs spread beyond the injection site. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for muscle-spasm conditions, an off-label use.

In a statement, the company said the FDA's ban on off-label promotion was particularly difficult since the agency had required the Botox safety update. "To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique," the company's statement said. "Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution."

Reuters is reporting that Allergan has also maintained that its lawsuit against the FDA is not in response to a federal investigation into Botox marketing that was launched by federal prosecutors last year.

FDA Issues Revised Botulinum Toxin Warnings

Tue, 04 Aug 2009 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) just announced an update to a previous safety alert on four botulinum toxin drug products, noting that all now contain boxed warnings on their labels and have developed Medication Guides for patients, which was directed by the agency in April 2009.

The boxed warning cautions that botulinum toxin effects may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life threatening swallowing and breathing difficulties and even death. For the most part, these dangerous, sometimes deadly symptoms have been reported in children with cerebral palsy who were being treated with the botulinum toxin for muscle spasticity, a nonapproved, off-label use of the drug. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The affected products are: Botox (new established name: onabotulinumtoxinA); Botox Cosmetic (new established name: onabotulinumtoxinA); Myobloc (new established name: rimabotulinumtoxinB); and Dysport (abobotulinumtoxinA), which was approved in April 2009 with the boxed warning and is not making name or label changes at this time.

No definitive serious adverse event reports of distant spread of toxin effect have been associated with dermatologic use of Botox/Botox Cosmetic at the recommended doses for frown lines between the eyebrows or severe underarm sweating. Also, no definitive serious adverse event reports of distant spread of toxin effect have been associated with Botox when used at approved doses for eyelid twitches or crossed eyes.

The FDA warns that the revised labels emphasize that the different botulinum toxin products are not interchangeable because the units used to measure the Botox/Botox Cosmetic products are different. To help reduce the potential for dosing errors, the botulinum toxin products have new established drug—also known as, “generic”—names. Neither the brand names nor the product formulations have changed.

We reported that last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said, at the time, that it had received reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated off-label for cerebral palsy-associated limb spasticity. The FDA said that adverse reactions may have been due to overdosing.

Earlier this year, the agency announced that all botulinum toxin injection products, including Botox and Botox Cosmetic, would carry a Black Box warning regarding the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected. In addition to the new warning, the agency also required the makers of these drugs to develop and implement a Risk Evaluation and Mitigation Strategy [REMS] plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

FDA Decision on Botox for Movement Disorder Delayed

Wed, 27 May 2009 00:00:00 -0700

Federal regulators have decided to wait on approving Botox as a treatment for upper limb spasticity in stroke victims. According to a Reuters report, the Food & Drug Administration (FDA) wants to review a bit more information before deciding to expand the approved use of Botox to include treatment of the movement disorder.

Allergan markets two Botox products. Botox Cosmetic is made from botulinum toxin type A, and is approved for temporary improvement in the appearance of moderate to severe facial frown lines. It is different from Botox, another Allergan botulinum toxin product, which is approved to treat conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).

Last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said at the time that it had received reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated off-label for cerebral palsy-associated limb spasticity. The FDA said that the adverse reactions may have been due to overdosing.

Late last month, the agency announced that all botulinum toxin injection products, including Botox and Botox Cosmetic, would carry a Black Box warning regarding the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected. In addition to the new warning, the agency is also requiring the makers of these drugs to develop and implement a Risk Evaluation and Mitigation Strategy [REMS] plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

According to Reuters, the FDA wants to review Allergan's proposed REMS for Botox before making a decision on its application for expanding its use. The agency is also seeking additional documentation and analysis of a clinical study included in the approval application. Finally, the FDA has also proposed certain label revisions, including one that could broaden Botox use to upper limb spasticity regardless of underlying cause, Reuters said.

The FDA is not requiring that Allergan conduct additional clinical trials for the new use of Botox , something that could have delayed the agency's decision by years, Reuters said. The company told Reuters that it could comply with the FDA's request within 60 to 90 days.

Botox Rival Dysport Approved by FDA

Fri, 01 May 2009 00:00:00 -0700

On the same day it announced a black box warning for Botox and similar drugs, the Food & Drug Administration (FDA) approved another botulinum toxin injection product for the U.S. market. But as we have reported previously, Dysport has been the subject of safety concerns in Australia - specifically, that it may result in birth defects if used to treat expectant mothers.

Like Botox and Botox Cosmetic, Dysport is made from botulinum toxin type A. It was approved by the FDA yesterday as both an anti-wrinkle treatment, and for treating spasms of the neck muscles. The drug is manufactured by Medicis Pharmaceutical Corp. of Scottsdale and its partner, France’s Ipsen SA. The cosmetic version of Dysport should be available in the U.S. within the next 30 to 60 day. The medical form should be available during the second half of the year.

Late last year, we reported that the Australian Federal Health and Ageing Department had released documents detailing the case of a baby who was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy. A 2006 report on the Australian birth defect case, written by the medical services manager for Ipsen, admitted a “possible” link with the drug’s use.

A month later, the Cosmetic Physicians Society of Australasia (CPSA) told its physicians to avoid using Dysport and similar products on pregnant women. “Botulinum toxin should not be prescribed to pregnant women and we advise our members to strictly follow these guidelines,” said the CPSA’s Dr Gabrielle Caswell said in a statement. “. . . there are some circumstances, such as during pregnancy, breastfeeding, glaucoma and neuromuscular disease where it is not an appropriate medication.”

The same day the FDA approved Dysport, it ordered the manufacturers of botulinum toxin injection products to add black box warnings - the agency's strictest safety alert - to their labels regarding their risk of potentially life-threatening complication when the effects of the toxin spread far beyond the injection site. According to the FDA, such an occurrence can cause symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. The agency said such symptoms have mostly been reported in children with cerebral palsy being treated with the products for muscle spasticity, an unapproved use of the drugs. Symptoms have also been reported in adults treated both for approved and unapproved uses.

The new warning label will apply to Dysport, as well as Allergan's Botox and Botox Cosmetic and Solstice Neurosciences' Myobloc. Botox Cosmetic is approved as a wrinkle treatment. Myobloc and Botox are approved for the treatment of spasms of the neck muscles. Botox is also approved for the treatment of severe underarm sweating (primary axillary hyperhidrosis), crossed eyes (strabismus), and abnormal tics and twitches of the eyelids (blepharospasm).

Botox, Similar Products To Bear Black Box Warnings

Thu, 30 Apr 2009 00:00:00 -0700

Botox, Botox Cosmetic and other botulinum toxin injections will bear new black box warnings regarding the risk of adverse events when toxin spreads beyond the site where it was injected. A black box warning is the Food & Drug Administration's (FDA) most serious safety warning.

Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. A third product, Myobloc, is made from botulinum toxin Type B and is approved for the treatment of adults with cervical dystonia.
The new black box warning will also apply to Dysport, a botulinum toxin product that was just approved for use in the U.S. by the FDA today.

The consumer advocacy group, Public Citizen had petitioned the FDA to issue warnings to doctors about hospitalizations and deaths associated with the use of botulinum toxin products. The group had pressed for a black box warning.

Last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said at the time that it had received reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.

In addition to the new black box warning, the FDA said today that it will require that manufacturers develop and implement a Risk Evaluation and Mitigation Strategy [REMS], including a communication plan to provide more information regarding the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged. The REMS would also include a Medication Guide that explains the risks to patients, their families, and caregivers.

The FDA also said today that it is requiring the manufacturers to submit safety data after multiple administrations of the product in a specified number of children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.

Explosion of Off-Label Botox Procedures Raises Concerns

Mon, 13 Apr 2009 00:00:00 -0700

The widespread, off-label use of Botox to treat everything from headaches to oily skin has many patient advocates worried. According to The New York Times, they are concerned that many off-label Botox procedures could hold hidden risks, as such therapies have not undergone extensive study.

Botox and Botox Cosmetic, both manufactured by Allergan, are purified forms of botulinum toxin, a nerve poison produced by the bacteria. Botox Cosmetic is approved for treating moderate to severe facial frown lines. Botox is medically approved for treating blepharospasm (involuntary blinking of the eye), cervical dystonia (involuntary contractions of the neck muscles), hyperhidrosis (excess sweating), and strabismus (crossed eyes).

According to The New York Times, many doctors believe that Botox is an effective therapy for other ailments. Physicians have used it to treat chewing problems, swallowing problems, pelvic muscle spasms, drooling, hair loss, anal fissures and pain from missing limbs, the Times said.

Such use is known as "off-label", and is entirely legal. Once a drug is approved by the Food & Drug Administration (FDA), physicians are free to use it any way they see fit. The Times report said as much as half of all Botox procedures are off-label.

But Botox is not without risks. Last February, the FDA launched a safety review of botulinum toxin injections, including Botox and Botox Cosmetic. The FDA said at the time that it had received reports of adverse reactions in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.

The consumer advocacy group, Public Citizen has petitioned the FDA to issue warnings to doctors about the hospitalizations and deaths associated with the use of botulinum toxin products. The group wants a “black box” added to product labels and an information pamphlet given to patients when the drug is injected.

Sidney Wolfe, director of Public Citizen, told The New York Times, that the safety of off-label Botox procedures have not been established. Such therapies amount to "trial and error with a nerve poison", Wolfe said.

According to the Times, when complications have occurred during off-label Botox procedures, they are often the result of overdosing. Because off-label treatments haven't been subjected to clinical trials, physicians often make an educated guess about dosing. But too much Botox can be toxic.

Obviously, Allergan sees other uses for Botox. With annual sales of $1.3 billion, Botox and Botox cosmetic have been big revenue generators for the company. According to The New York Times, Allergan has applied for patents on more than 90 uses for the drug. This year, it will ask the FDA to approve Botox as a treatment for stroke victims suffering from limb tightness or spasms. It is also expected to soon seek approval to market it as a treatment for migraine headaches and enlarged prostate.

If such uses are approved, Botox could become an even bigger blockbuster for Allergan. According to the Times, sales of Botox could easily double within the next five to seven years.

Botox Not for Pregnant Women, Australian Medical Group Warns

Fri, 30 Jan 2009 00:00:00 -0800

Doctors in Australia are warning pregnant women to avoid Botox and other wrinkle treatments made with botulinum toxin. The warning comes after health authorities there reported that an expectant mother treated with a Botox rival called Dysport gave birth to a baby who was blind and deaf.

Several botulinum toxin treatments are currently approved for use in the U.S. Botox, which like Dysport is made with botulinum toxin Type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).

Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

Dysport is not currently approved as a treatment in the U.S. However, the drug's manufacturer has submitted an application to the U.S. Food & Drug Administration (FDA), and hopes to have approval from the agency to market the drug as a treatment for cervical dystonia by mid-2009. The maker of Dysport is also seeking approval for a version used to treat wrinkles called Reloxin.

Last month, the Australian Federal Health and Ageing Department released documents detailing the case of a baby who was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy. A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufacturer Ipsen, admits a “possible” link with the drug’s use.

On Tuesday, The Cosmetic Physicians Society of Australasia (CPSA) told its physicians to avoid using Botox and similar products on pregnant women. "Botulinum toxin should not be prescribed to pregnant women and we advise our members to strictly follow these guidelines," said the CPSA's Dr Gabrielle Caswell said in a statement. ". . . there are some circumstances, such as during pregnancy, breastfeeding, glaucoma and neuromuscular disease where it is not an appropriate medication."

Botox Safety Label Updated for Serious Side Effects, Health Canada Said

Wed, 14 Jan 2009 00:00:00 -0800

Health Canada has announced that the label for Botox Cosmetic Products sold in that country will be updated to include new safety warnings. The warnings will now include the risk of the toxin spreading to other distant parts of the body. Possible symptoms of "distant toxin spread," which can be fatal, include muscle weakness, swallowing difficulties, pneumonia, speech disorders and breathing problems, Health Canada said.

Botox and Botox Cosmetic, manufactured by Allergan Inc., is the only botulinum toxin products marketed in Canada. Botox is indicated for the treatment of muscle spasms in the neck, eye and foot, muscle pain, and excessive sweating. Botox Cosmetic is indicated for cosmetic purposes, to treat facial wrinkling.

In October, Health Canada said that five Canadians have died following Botox injections, prompting it to launch an investigation. At the time, Health Canada said it was also looking into eight reports of serious reactions following Botox treatment. The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that occurs when food or liquids are inhaled into the respiratory tract and lungs.

According to Health Canada, only one of the 13 reports it had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as “distant toxin spread.” However, “10 of the 13 cases were deemed to be serious owing to life-threatening reaction (one case), hospitalization (three cases), ongoing disability (one case) or fatal outcome (five cases),” the agency said in its most recent adverse reaction newsletter.

Two deaths occurred in children with cerebral palsy. As is the case in the U.S., Botox has not been approved for such use in Canada. The other deaths involved three women in their 60s, all of whom had underlying medical conditions such as Parkinson’s or cerebral palsy.

In addition to announcing the new labeling, Health Canada has advised Canadians using Botox and Botox Cosmetic products to seek immediate medical care if swallowing, speech or breathing disorders arise. Canadians with a history of underlying neurological disorders, swallowing difficulties and/or breathing problems should use these products with extreme caution. Botox and Botox Cosmetic products should only be used under specialist supervision in those patients and should only be used if the benefit of treatment is considered to outweigh the risk, Health Canada said.

Last February, the U.S. Food & Drug Administration (FDA) launched its own investigation of botulinum toxin injections, including Botox, Botox Cosmetic, and Mylobloc. In the U.S., Botox is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Mylobloc is approved for the treatment of adults with cervical dystonia.

The FDA said at the time that it had received reports of adverse reactions in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.

Last month, we reported that Australian health regulators revealed that a mother treated with another botulinum toxin Type A product gave birth to a baby with severe birth defects. The drug implicated in that incident is called Dysport, which while not yet approved in the U.S., contains the same active ingredient found in Botox and Botox Cosmetic.

Botox Rival and Birth Defects: A Possible Link

Tue, 30 Dec 2008 00:00:00 -0800

Keywords: Botox Lawyer Birth Defects Attorney

The lawyers at our firm are offering free consultations to anyone treated with Botox or similar products while pregnant, who later had a child with birth defects. In December 2008, Australian authorities reported that a wrinkle treatment called Dysport had been linked to severe birth defects in one child. Dysport contains botulinum toxin Type A, the active ingredient in Botox and Botox Cosmetic.

Consumer information for Botox and Botox Cosmetic recommends against treatment when pregnant. However, in light of the safety issues reported in Australia, the Botox birth defect lawyers at our firm are concerned that these warning are inadequate, and do not offer enough protection to patients.

If your child suffers from birth defects that might be tied to Botox or Botox Cosmetic, you may be entitled to compensation. Please contact our Botox birth defect lawyers as soon as possible to protect your legal rights.

Australian Birth Defect Report

In December 2008, the Australian Federal Health and Ageing Department released documents detailing a case of severe birth defects in a child whose mother was treated with Dysport while pregnant. The Botox birth defect lawyers at our firm are conducting an investigation to find out if people treated with other botulinum toxin Type A products, such as Botox and Botox Cosmetic, have had similar experiences.

According to Australian health regulators, the baby was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy. The case was among 46 different adverse reactions to botulinum toxin Type A reported to the Therapeutic Goods Administration since July 1, 1994. A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufactur Ipsen, admits a "possible" link with the drug's use.

Dysport is not currently approved as a treatment in the U.S. However, the drug's manufacturer has submitted an application to the U.S. Food & Drug Administration (FDA), and hopes to have approval from the agency to market the drug as a treatment for cervical dystonia by mid-2009. The maker of Dysport is also seeking approval for a version used to treat wrinkles called Reloxin. If either of these treatments are approved, our Botox birth defect lawyers will be watching closely to see if patients experience problems similar to what was reported in Australia.

Other Side Effects

Several botulinum toxin treatments are currently approved for use in the U.S. These include Botox, Botox Cosmetic and Myobloc. Our Botox birth defect lawyers would like to hear from anyone whose child suffered a birth defect following treatment with any of these medications.

Botox, which like Dysport is made with botulinum toxin Type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

In addition to a possible association with birth defects, these drugs have been linked to other serious side effects. Our firm is also offering free consultations to anyone suffering from other problems possibly associated with Botox, Botox Cosmetic or Myobloc.

In January 2008, the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings on the products' labels because of serious adverse reactions. An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.

In February 2008, the FDA announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children. According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs.

At the time, the FDA said that many reported reactions resembled botulism, and occurred when botulinum toxin spread beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death. The FDA said that the adverse reactions may have been due to overdosing.

Legal Help for Victims of Botox Birth Defects

If your child suffers from birth defects that you believe are the result of treatment with Botox, Botox Cosmetic or Myobloc, you may have valuable legal rights. Please fill out our online form or call 1-800 LAW INFO (1-800-526-4636) as soon as possible to discuss your case with one of our Botox birth defect lawyers.

Birth Defects Linked to Botox - Type Drug

Tue, 30 Dec 2008 00:00:00 -0800

New questions are being raised about the safety of Botox and similar wrinkle treatments after Australian health regulators revealed that a mother treated with another botulinum toxin Type A product gave birth to a baby with severe birth defects. The drug implicated in that incident is called Dysport, which while not yet approved in the U.S., contains the same active ingredient found in Botox and Botox Cosmetic.

Earlier this week, the Australian Federal Health and Ageing Department released documents detailing the case of a baby who was born deaf and blind in November 2005 after the mother was given facial cosmetic injections of Dysport in the first week of pregnancy. A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufacturer Ipsen, admits a "possible" link with the drug's use.

Several botulinum toxin treatments are currently approved for use in the U.S. Botox, which like Dysport is made with botulinum toxin Type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

In February 2008, the U.S. Food & Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children. According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs. At the time, the FDA said that many reported reactions resembled botulism, and occurred when botulinum toxin spread beyond the site where it was injected.

While Dysport is not currently approved as a treatment in the U.S, the drug's manufacturer has submitted an application to the FDA, and hopes to have approval from the agency to market the drug as a treatment for cervical dystonia by mid-2009. The maker of Dysport is also seeking approval for a version used to treat wrinkles called Reloxin.

Botox Deaths Under Investigation in Canada

Thu, 09 Oct 2008 00:00:00 -0700

Five Canadians have died following Botox injections, prompting health regulators in that country to launch an investigation. Health Canada said it is also looking into 8 reports of serious reactions following Botox treatment.

All of the deaths occurred in people who had received Botox injections to treat medical conditions such as neck and muscle spasms. Using Botox to treat conditions like muscle spasms requires much higher doses than what is typically used to eliminate wrinkling .

This past February, the U.S. Food & Drug Administration (FDA) launched its own investigation of botulinum toxin injections, including Botox, Botox Cosmetic, and Mylobloc. In the U.S., Botox is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Mylobloc is approved for the treatment of adults with cervical dystonia.

The FDA said at the time that it had received reports of adverse reactions in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may have been due to overdosing.

In the U.S., the group Public Citizen has petitioned the FDA issue warnings to doctors about the hospitalizations and deaths associated with the use of botulinum toxin products. The group wants a "black box" added to product labels and an information pamphlet given to patients when the drug is injected.

The Botox reactions reported in Canada included throat swelling, respiratory arrest, difficulty swallowing and aspiration pneumonia, and infection that occurs when food or liquids are inhaled into the respiratory tract and lungs.

According to Health Canada, only one of the 13 reports it had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as "distant toxin spread." However, "10 of the 13 cases were deemed to be serious owing to life-threatening reaction (one case), hospitalization (three cases), ongoing disability (one case) or fatal outcome (five cases)," the agency said in its most recent adverse reaction newsletter.

Two deaths occurred in children with cerebral palsy. As is the case in the U.S., Botox has not been approved for such use in Canada. The other deaths involved three women in their 60s, all of whom had underlying medical conditions such as Parkinson's or cerebral palsy.

Botox Lawsuit Filed Over Deaths and Injuries

Tue, 15 Jul 2008 00:00:00 -0700

A lawsuit against Botox Cosmetic was just filed and states that Botox killed four and injured 11. Plaintiff’s attorneys are urging for an end to the promotion of Botox’s off-label use and are requesting physicians be better trained in its use. The four deaths included two children and two adults according to the attorneys who added, "The two were children with cerebral palsy and they got very high doses to treat spasticity." The two adults were a 69-year-old woman who died in March after receiving Botox to treat her shoulder and neck pain and a 60-year-old man who died in April after receiving Botox for excessive salivation.

Botox Cosmetic is approved for treating moderate to severe facial frown lines. Botox is medically approved for treating blepharospasm (involuntary blinking of the eye), cervical dystonia (involuntary contractions of the neck muscles), hyperhidrosis (excess sweating), and strabismus (crossed eyes); Myobloc is only approved for the neck condition. Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them. In off-label use, a physician uses a drug to treat a condition for which it is not specifically approved but for which evidence suggests it will help.

Meanwhile, the lawsuit claims that Botox maker Allergan promotes "off label" use for treating patients with cerebral palsy and other conditions not approved by the Food and Drug Administration (FDA) and that Allergan fails to appropriately warn Botox users of the possibility of fatal and life-threatening injuries from Botox injections. Another physician, Alan Gold, MD, a plastic surgeon in Great Neck, N.Y., and president of the American Society for Aesthetic Plastic Surgery, says off-label use carries additional risk that consumers need to be aware of. Only three of the 11 plaintiffs received Botox for cosmetic purposes; the remainder were treated with Botox for other conditions. Plaintiffs complaints included droopy eyelids, numbness, headaches, and swallowing and breathing problems.

By January, Botox and Myobloc were linked to 16 deaths and more hospitalizations due to botulinum toxin spreading inside the bodies of those patients. In response, Public Citizen, a U.S. consumer group, called for stronger warnings on the drugs and asked U.S. authorities to require the strongest possible warning—the black box—to be included on Allergan Inc.'s Botox and Solstice Neurosciences Inc.'s Myobloc. In February, the FDA announced its ongoing evaluation of reports of adverse reactions such as respiratory problems and death following the use of Botox and Myobloc for approved and unapproved uses.

Public Citizen said it reviewed 180 FDA reports involving patients injected with Botox or Myoblo, which detailed muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs. Sixteen cases were fatal and four of these involved children under 18; there were also 87 patient hospitalizations. Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis. Early symptoms of botulinum toxin include dry mouth, difficulty breathing or swallowing, slurred speech, drooping eyelids, and muscle weakness.

Botox Complications Require Caution

Wed, 02 Jul 2008 00:00:00 -0700

This year, Botox was linked to a number of hospitalizations and 16 deaths. Of the deaths, four victims of the poisonous Botox injections were children. An additional 87 people were hospitalized. Botox and Myobloc have been linked to the injuries and fatalities because the botulinum toxin spread inside the bodies of the patients, killing some and injuring others. The toxin spreading in the bodies of the children proved most serious, killing four children under the age of 16. In addition to the deaths, there have been reported problems of muscle weakness and difficulty swallowing. American consumer group Public Citizen says it has seen 180 reports sent to the US Food and Drug Administration (FDA) about Botox and Myobloc.

Botulinum toxin, which is produced by the bacterium Clostridium botulinum and is known commercially as Botox and Myobloc, is one of the most powerful nerve poisons known. Although best known for smoothing facial wrinkles, Botox is medically approved for treating cervical dystonia, or rigid neck muscles and is also used to treat stroke victims and medical conditions including excessive sweating. Myobloc is only approved for the neck condition. Both injections are made with forms of the botulinum toxin, which blocks nerve impulses to muscles, relaxing them. In children, Botox is used when neurological disorders are present, such as Cerebral Palsy. Injections are meant to allow the child to gain normal movement by weakening stronger muscles and strengthening weaker ones by forcing the stronger contracting muscles to relax. While experiencing the drug’s effects, physical therapists work with the child to develop the weaker muscles. Although not appropriate for all children with CP, the treatment may help some move normally. Recently, the toxin is being used off-label to treat unremitting overactive bladder problems that do not respond to other therapies.

Of the seven types of botulism, only two—A and B—are currently used medically. Of the products available in the United States, Botox and Botox Cosmetic are derived from botulinum toxin A and Myobloc from B. This February, the FDA—which continues its safety review of these products—notified the public about reports of ill effects associated with the drugs.

It has long been known that injecting botulinum can cause unwanted effects in nearby muscles; injections to smooth eye creases may cause temporary eyelid drooping; however, there are more serious concerns over systemic reactions, or effects on distant muscles. And, the FDA says that adverse effects do not always occur right away and may emerge weeks after treatment.

In addition to the 16 deaths, Public Citizen reviewed the FDA’s adverse-event reports and found 180 cases of serious effects like pneumonia and difficulty swallowing and breathing. In September 2005, the Centers for Disease Control and Prevention (CDC) reviewed 1,437 adverse reports: 406 after medical use of Botox—217 of them serious effects—and 1,031 after cosmetic use—36 serious. Reports detailed cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs. Wolfe said such problems could occur if botulinum toxin spreads from the injection site to places such as the esophagus, causing partial paralysis.

Cosmetic Skin Fillers May Cause Delayed Side Effects

Wed, 21 May 2008 00:00:00 -0700

A new study is saying that cosmetic skin fillers—called polyalkylimide implant injections—may cause infrequent, but sometimes severe, immune-related side effects months after treatment, Spanish researchers warn. The implants, which consist of gel and water, are used in cosmetic facial procedures for facial areas such as the lips, cheeks, forehead, and nasolaial folds, those lines that develop between the nose and mouth.

"In the early reports on polyalkylimide implant injections for cosmetic purposes, there were no significant signs of bioincompatibility (rejection of, or reaction to, the foreign material). Recent evidence disprove these statements, and so the complete safety of polyalkylimide implant gels can no longer be assured," wrote Dr. Jaume Alijotas-Reig, of Vall d'Hebron University Hospital and Autonomous University of Barcelona, and colleagues. The study assessed 25 patients who developed adverse effects 12 months or more after polyalkylimide implant injection. Adverse effects included swelling, hardening, and swollen or tender nodules (skin lesions) near the injection site, as well as systemic troubles such as fever, arthritis, and dry eyes or mouth.

"Eight patients were previously injected with another implant," the study authors wrote. "Tender inflammatory nodules were seen in 24 patients. Systemic or distant manifestations appeared in six cases. Laboratory abnormalities were found in 20 cases. After an average of 21.3 months of follow-up, 11 patients appeared to be free of adverse effects, and 10 still had recurrent bouts." The rate of these delayed adverse events is unclear, said the authors. Study findings were published in the May issue of the journal Archives of Dermatology. "Considering the increased use of polyalkylimide implants in European countries and in the United States, physicians should be aware that intermediate or delayed adverse effects can occur with polyalkylimide implants just as they can with collagen, polyacrylamide, polylactic acid or methacrylate (cosmetic fillers)," the authors wrote.

Meanwhile, the popular skin injection generally used to smooth wrinkles was linked to a number of hospitalizations and 16 deaths. Of the deaths, four of the victims of the poisonous Botox injections were children. An additional 87 people were hospitalized. Botox and Myobloc have been linked to the injuries and fatalities because the botulinum toxin spread inside the bodies of the patients, killing some and injuring others. The toxin spreading in the bodies of the children proved most serious, killing four children under the age of 16.

As well as deaths, there have been reported problems of muscle weakness and difficulty swallowing. And, American group Public Citizen says it has seen 180 reports sent to the US Food and Drug Administration (FDA) about Botox and Myobloc. Spokesman Dr. Sidney Wolfe—director of Public Citizen’s Health Research Group—said users should be told of early symptoms such as dry mouth, trouble breathing, slurred speech, or droopy eyelids, adding “Significantly improved warnings would increase likelihood of earlier medical intervention and could prevent complications, including death.” Reports detailed cases of muscle weakness, difficulty swallowing, or aspiration pneumonia, a serious condition caused by breathing a foreign material into the lungs.

Botox Study Shows Migration to the Brain

Thu, 03 Apr 2008 00:00:00 -0700

A new Botox study indicates that the antiwrinkle treatment could actually migrate from a recipient's face to the brain. Botox is made with botulism toxin, one of the world's most poisonous substances, which can lead to a paralyzing illness. Word of this latest Botox study - published in the latest issue of the Journal of Neuroscience - comes just weeks after the Food & Drug Administration (FDA) announced that it was beginning a safety review of Botox and other similar drugs.

Botox, which is made with botulinum toxin type A, is approved in the US for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. A similar drug, Myobloc, is made from botulinum toxin Type B, and is approved for the treatment of adults with cervical dystonia.

According to the FDA, there have been reports of Botox, Botox Cosmetic and Myobloc reactions that are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

Now, scientists from the Italian National Research Council's Institute of Neuroscience in Pisa who were conducting experiments with Botox in rats have found that the toxin can make its way to the brain in those lab animals. Although rats and humans have a different physiology and their responses may vary, the researchers said say the results should lead to more research.

In the study, the whisker muscles of rats were injected with the toxin. Within three days, the scientists discovered traces of potentially deadly botulism in the rodents' brain stems. The study's author, Matteo Caleo, said the toxin also moved from one hippocampus, which controls long-term memory and spatial navigation, to the hippocampus on the other side of the rat's brain. The botulism toxin was still present in the rats' brains after six months.

Last month, another Botox study conducted by researchers at the University of Calgary experimenting on cats also found that the botulism toxin from Botox could migrate to other parts of the body. The Calgary team injected the toxin into a muscle at the back of the leg of cats. Four weeks later, the time it takes for Botox to have its full effect, they measured the strength of this muscle, and that of a neighboring muscle. The Botox study revealed the toxin passed easily into the surrounding muscles and weakened all the muscles in the area. The results support other research that has already shown that botulinum can pass through tissue surrounding muscle.

Allergan, the California-based company that makes Botox, told the UK newspaper "The Daily Mail" that the Italian research was not conclusive and contradicted previous findings. "The authors used a laboratory preparation of botulinum toxin and did not use Botox," said a spokesman. "Data suggests that different preparations of botulinum toxin react differently in both the laboratory and in clinical practice."

Botox Study Finds Toxin Can Invade Other Muscles

Tue, 11 Mar 2008 00:00:00 -0700

Botox can migrate to other parts of the body, placing patients at risk for developing symptoms of the paralyzing illness botulism, a news study says. The study contradicts assurances made by the maker of Botox, and comes just weeks after the Food & Drug Administration (FDA) announced that it was beginning a safety review of Botox and other similar drugs.

Botox, which is made with botulinum toxin type A, is approved in the US for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. A similar drug, Myobloc, is made from botulinum toxin Type B, and is approved for the treatment of adults with cervical dystonia.

According to the FDA, there have been reports of Botox, Botox Cosmetic and Myobloc reactions that are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S.

It has been widely assumed that Botox stayed in the muscle after it was injected and was therefore safe - but new research contradicts this. In the study, conducted at the University of Calgary, in Canada, and published in the Journal of Biomechanics, it was found that the product is not as easy to control as previously thought. Experimenting on cats, the Calgary team injected the toxin into a muscle at the back of the leg. Four weeks later, the time it takes for Botox to have its full effect, they measured the strength of this muscle, and that of a neighboring muscle.

The Botox study revealed the toxin passed easily into the surrounding muscles and weakened all the muscles in the area. The results support other research that has already shown that botulinum can pass through tissue surrounding muscle.

Allegan, the company that makes Botox, insists that the drug is safe, and points to the fact that it has been in use for more than 20 years. Still, Botox recipients have been warned to seek immediate medical attention if they experience worsening or unexpected difficulty in swallowing or talking, trouble breathing or muscle weakness following any injection.

Allergan Subpoenaed Over Botox

Tue, 04 Mar 2008 00:00:00 -0800

The maker of Botox is facing heat over off-label use of the product. Yesterday, Allergan Inc. said it received a subpoena from the US Department of Justice investigating the promotion of Botox. The drugmaker said authorities were seeking documents regarding promotional, educational, and other activities relating to Botox and said it believes the subpoena is related to alleged off-label promotion of Botox to treat headaches. Botox, best known for smoothing facial wrinkles, is not approved as a headache treatment.

Botox and similar drugs are already at the center of a Food & Drug Administration (FDA) safety review. The review came after the FDA received reports of systemic adverse reactions including respiratory compromise and death following use of botulinum toxins types A and B for both FDA-approved and -unapproved uses. Botox and another drug, Myobloc have been linked to 16 deaths and more hospitalizations; reactions reported are suggestive of botulism in which the toxin spreads in the body beyond the injection site. The most serious cases involved hospitalization and death and occurred mostly in children treated for cerebral palsy-associated limb spasticity (severe arm and leg muscle spasms). Use of botulinum toxins for this purpose is not approved in the US in children or adults. The FDA is aware of the literature describing the use of botulinum toxins to treat limb spasticity; however, the safety, efficacy, and dosage of botulinum toxins have not been established for the treatment of limb spasticity of cerebral palsy or for use in any condition in children under 12.

Botox (botulinum toxin type A) is medically approved for treating cervical dystonia (rigid neck muscles), blepharospasm (eyelid spasm), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic (botulinum toxin Type A) is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children has not been established. The botulinum toxin blocks nerve impulses to muscles, relaxing them.

The FDA is reviewing data from clinical studies submitted by the manufacturers of Botox, Botox Cosmetic, and Myobloc, as well as post-marketing adverse event reports, and medical literature. Current labeling for Botox, Botox Cosmetic, and Myobloc describes adverse reactions occurring near the injection site for each product’s approved uses. The Warnings sections for the products note that important systemic adverse effects, including severe difficulty swallowing and breathing occurred in patients with neuromuscular disorders after local injection of typical. The FDA now has evidence that similar, potentially life-threatening events can occur following local injection in those with underlying conditions such cerebral palsy associated limb spasticity.

Until the FDA has completed its review, healthcare professionals who use medicinal botulinum toxins should understand that potency amounts indicated by “Units” or “U” differs among the products and are not comparable from one product to the next. They should also be alert to the potential for adverse effects and know effects have been reported as early as one day and as late as several weeks following treatment, providing patients and caregivers with the information to identify the signs and symptoms of these effects, especially worsening or unexpected difficulty swallowing or talking, trouble breathing, or muscle weakness.

Botox Lawsuit

Tue, 04 Mar 2008 00:00:00 -0800

Health Canada Safety Information Regarding Botox

Botox, Myobloc Linked to Serious Side Effects, Deaths

In February 2008, the Food & Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children. Botox, Botox Cosmetic and Myobloc are injectable drugs that contain botulinum toxin. According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs.

Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating). Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

Botox, Botox Cosmetic, and Myobloc Side Effect Reports

In January 2008, the consumer advocacy group Public Citizen petitioned the agency two weeks ago to strengthen warnings on the products' labels because of serious adverse reactions. An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.

According to the FDA the Botox, Botox Cosmetic and Myobloc reactions reported resemble botulism. The reactions have occurred when botulinum toxin spreads beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may be due to overdosing

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis. Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities. Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported.

Legal Help

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