Yourlawyer.com (Protopic News) http://www.yourlawyer.com/topics/overview/protopic Sat, 21 Nov 2009 05:29:43 -0800 pixel-app en FDA Orders 'Black Box' Warning for Eczema Drugs, Elidel and Protopic http://www.yourlawyer.com/articles/read/11185 Sat, 21 Jan 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11185
The new labeling will add a black box warning about a possible cancer risk. The boxed warning lets healthcare professionals know that the long term safety of the drugs is yet to be established.

A Medication Guide (FDA-approved patient labeling) will also be included with the medications in order to “ensure that patients using these prescription medicines are aware of this concern.

The updated labeling clearly states that these drugs are recommended for use as second-line treatments, meaning they should be used only after other prescription topical medicines have been tried.

These drugs are not recommended for use in children under 2 years of age.

"We are taking steps to ensure that healthcare providers and patients are aware of the possible long-term risks of these products so that they will be used appropriately", said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research (CDER). "Today's actions are aimed at making sure that health care providers and consumers understand the new warnings and that it is important that these products be used as recommended in the label."

On February 15, 2005, FDA's Pediatric Advisory Committee first recommended that the labeling be updated with a boxed warning and a Medication Guide about the possible cancer risk for these topical drugs.

In addition, FDA had issued a Public Health Advisory in March 2005 advising healthcare professionals about the possible cancer risk, and indicated that it would ask the sponsors to update the labeling to address this possible risk.

As stated in today’s release: “Although a causal link has not been established, rare reports of cancer (for example, skin and lymphoma) have been reported in patients who had been receiving these products.”

Currently, studies are being conducted by the manufacturers of both drugs to find out further information about the cancer risk, but it could be several years before the research is concluded.

In the meantime, the FDA says, these drugs can be beneficial to patients when used appropriately. For instance, they may be effective when other prescription topical medications are not an option for patients.

According to the FDA release, the drugs “are intended to be used for short periods, but if a patient requires a longer period of treatment, the treatment can be repeated after a period of time off treatment.

Patients are advised to call their doctor if symptoms worsen, they develop an infection, or if symptoms do not improve within the six weeks of treatment.”

Pharmacists are required to provide the Medication Guide to patients when filling prescriptions for the drug. Patients are advised to thoroughly read the Medication Guide and discuss any questions they might have with their healthcare provider.

Astellas Pharma, Inc (formerly Fujisawa Healthcare) the manufacturer of Protopic ointment, and Novartis, manufacturer of Elidel cream, said the drugs are safe in interviews and statements Thursday.

"The changes to the label are focused on a potential risk, not on a proven or known risk," said Joyce Rico, a vice president at Astellas.

In a statement, Novartis said that the FDA's concern about a cancer risk is based on studies that used high doses. Although they agreed to change the labeling, the company believes "this action is not substantiated by scientific or clinical evidence."
]]> FDA to Require Warnings on 2 Eczema Drugs http://www.yourlawyer.com/articles/read/11182 Fri, 20 Jan 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11182
The Food and Drug Administration action Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings.

The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said. The agency is also issuing a guide updating patients of its concerns.

A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk.

"This is something that is a possible risk, is a long-term possibility and is something that still needs to be researched," FDA spokeswoman Susan Cruzan said.

As of October, the FDA has received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with the two drugs, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division.

Novartis Pharmaceuticals, which makes Elidel, said in a statement Thursday that it remained confident in the safety and efficacy of Elidel.

"While Novartis believes this action is not substantiated by scientific or clinical evidence, Novartis has agreed to make the requested changes," the company said.

Astellas Pharma Inc., formed through the merger of Protopic maker Fujisawa Healthcare Inc. and Yamanouchi Pharmaceutical Co., said in a statement that its drug "is safe and effective when used in a manner consistent with its label."

"It addresses a theoretical risk a potential risk, not a demonstrated link," Dr. Joyce Rico, vice president for medical sciences research and development at Astellas, said of the warning.

While the two manufacturers dispute whether there is a cancer link, the FDA felt it had to convey notice of the cancer reports to doctors and patients, said Dr. Julie G. Beitz, an acting director of one of the FDA's drug evaluation offices.

Along with the small number of cancers reported in both children and adults treated with the drugs, animal tests have shown an increase in cancer associated with the drugs, the FDA said last year.

No causal link between use of the drugs and cancer has been established, Beitz said.

The long-term safety of the drugs has not been established, according to the FDA. While both companies are studying that issue, the results may not be known for years, the FDA said.

Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system.

The companies estimate that roughly 10 million people combined have used the two drugs.]]> Health Alert for Eczema Patients http://www.yourlawyer.com/articles/read/9720 Tue, 03 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9720
But Canadian dermatologists say the warnings are overkill.

Health Canada has linked Elidel and Protopic ointment to a potential cancer risk.

The agency is worried about a connection to lymphoma.

The advisories don't advise patients to stop using the treatment but do warn that they should be used only as directed.

The drug companies have also been asked to update safety information on the labels.

The Canadian Dermatology Association says it has been receiving numerous calls from worried patients.

Dermatologists say the warning is unnecessary and the risk is minimal if it exists at all.

Eczema is an immune disorder than can be very painful and result in serious infections.]]> FDA Panel Urges Warnings on 2 Eczema Drugs http://www.yourlawyer.com/articles/read/9341 Wed, 16 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9341
Although the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take steps to aggressively caution consumers and monitor the drugs' safety, including adding a prominent "black box" to the labels.

The FDA is not required to follow the advice of its expert panels but usually does.

Officials at Novartis Pharmaceuticals Corp., which makes Elidel, said they were disappointed by the recommendation, which they said was unnecessary.

Protopic was approved in 2000 and Elidel in 2001 to treat eczema, a chronic, incurable skin condition that causes sometimes disfiguring and even disabling redness, itching and scaling for millions of Americans. Both products control the condition by suppressing the immune system.

Before their approval, the only available treatment was steroid drugs, which can cause harmful side effects.

Although the new medications were approved only for short-term or intermittent use by adults and children 2 or older, the treatments have become increasingly popular, and the number of new prescriptions has risen especially quickly in the past year. More than 12 million prescriptions have been written, with Elidel much more widely advertised than Protopic and far outselling it.

The number of prescriptions sold for pediatric use has increased the quickest, and both medications are believed to be widely used for babies younger than 2.

When the medications were approved, experts said animal and laboratory studies suggested that the drugs might increase the risk of cancer. That prompted the FDA to require the companies to monitor closely their safety record.

Agency officials have since become increasingly concerned as the drugs' popularity soared and the number of cancers reported among users slowly accumulated. At least 30 cases have been reported primarily forms of skin cancer and lymphoma, an immune-system cancer.

"There is an emerging signal in the types of tumors being reported," said the FDA's Bindi Nikhar.

During a day-long hearing, FDA officials described evidence from animal studies suggesting a cancer risk, including a monkey study that indicated a possible link to lymphoma.

Jeffrey Cohen of the National Institute of Allergy and Infectious Diseases told the panel that the drugs could increase the risk of cancer by suppressing the immune system's ability to control the Epstein-Barr virus, a ubiquitous infection that is often harmless but can lead to cancer.

FDA officials said it would take years before research could clarify the situation.

"What we are dealing with is an unknown degree of risk," the FDA's Dianne Murphy told the panel. "It will take too many years before we will have a definitive answer. Many children will have been exposed, and we are concerned it will be too little information too late."

Officials from Novartis and Fujisawa Healthcare Inc., which makes Protopic, argued that both products were extensively tested in thousands of patients and that there was no sign of cancer occurring more frequently among those using the products.

"There is no evidence of an increased risk of malignancies," said Thomas Hultsch of Novartis.

Both companies said they are carefully monitoring users for signs of serious side effects.

"We are committed to the safety of our patients," said M. Joy Rico of Fujisawa.

Several dermatologists and patients' representatives told the panel that the drugs are crucial for people suffering from the condition, especially those with severe cases.

"These medications have given patients some relief for a tortured existence that most people just can't imagine," said Jim Hendricks of the National Eczema Association for Science and Education, an advocacy group for patients. ]]> FDA Considers Warnings for Eczema Creams http://www.yourlawyer.com/articles/read/9315 Sat, 12 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9315
A handful of cases of cancer have been reported among adults and children using the creams, sold under brand names Elidel and Protopic, and animal and laboratory studies suggest the drugs could be to blame, according to a new Food and Drug Administration analysis.

"The evidence raises serious safety concerns in children regarding the potential for carcinogenicity in humans treated with these agents," wrote Jean Temeck of the FDA's division of pediatric drug development in a recommendation posted late yesterday on the agency's Web site.

The document was one of several posted in preparation for a meeting of an expert panel next week to assess the safety of the creams and recommend what action the agency should take.

Protopic and Elidel were approved in 2000 and 2001, respectively, to treat eczema, a common, chronic skin condition that causes redness and itching. Before the new creams, the only treatment had been steroid creams and ointments, which can be used only for short periods and can have a variety of side effects.

The new creams, which were seen as effective and much safer, immediately became popular. At least 5 million prescriptions have been written for the creams.

The creams were approved for short-term or intermittent use by adults and children age 2 and older, but Novartis Pharmaceuticals Corp. has marketed Elidel aggressively, and both creams are believed to be widely used for longer periods and among babies.

"These products are being widely used to treat a non-life-threatening disease, and heavily advertised for use in young children without appreciation regarding the potential for carcinogenic risk," Temeck wrote.

Both Novartis and Fujisawa Healthcare Inc., which makes Protopic, defended the safety of their products to the FDA.

"Elidel is an effective, steroid-free treatment for mild to moderate eczema and has a well-established safety profile," Novartis spokesman Tom Jones added in an e-mail.

Because the drugs work by suppressing the immune system, scientists had been concerned that they could increase the risk of cancer. As a result, when the FDA approved the creams the agency required both companies to monitor whether any cancers were reported among users.

In 2003, the agency convened an expert panel to examine the evidence to date, but at that time only seven possible cases had been reported, so the agency decided to continue to monitor the situation.

Since then, however, a study involving monkeys has suggested the creams might cause lymphoma, a cancer of the immune system, and reports of a variety of cancers in humans using the creams have continued to rise.

At least seven cases of lymphoma have been reported, as well as at least seven cases of skin cancer and a handful of others, Temeck wrote. Several children reported infections, including an 8-month-old boy whose infection was so severe he suffered a heart attack after Protopic was applied "over his entire body for six months," she wrote.

While it remains far from proven that the creams are causing the complications, "there is a need for a stronger approach to the communication and minimization of the potential risk of cancer," Dianne Murphy, director of the FDA's office of pediatric therapeutics, wrote in another document.

"We believe regulatory action is needed at this time since a definitive answer to the carcinogenic risk of these products will not be known for years," Temeck wrote.

The addition of a possible "black box" warning to the label is one of several recommendations that the committee will consider, an agency spokesman said.

The concern comes as the FDA has come under intense criticism for failing to protect the public from potentially dangerous drugs. The blockbuster painkiller Vioxx was recently pulled from the market because of concerns that it and similar agents may increase the risk of heart attacks and strokes.

The advisory committee will focus on children because exposure to a potential cancer-causing agent poses a greater risk to the young, but its recommendations would apply to adults as well, the spokesman said.

Although the FDA is not bound to follow the recommendations of its advisory panels, it usually does.]]> Protopic Skin Cancer Side Effects Melanoma Lawyer http://www.yourlawyer.com/topics/overview/protopic Sat, 12 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/protopic DOWNLOAD OUR Protopic INFORMATION PACKAGE

Injured by Protopic?

Protopic (Generic:Tacrolimus) is a cream approved for the treatment of eczema and is commonly prescribed off-label for psoriasis and dermatitis seborrhea. Protopic is manufactured by Astellas Pharmaceuticals, formerly Fujisawa Healthcare, and was approved by the FDA in 2000.

The FDA required a warning for Protopic and Elidel after reviewing numerous animal studies that did indicate a risk, including one monkey study that showed an increasing risk of developing tumors as doses increased. The FDA added that the cancer risks of Elidel and Protopic are biologically plausible. Protopic and Elidel are medications that suppress the immune system, and this may be a precipitating factor in the development of cancer. Research has also linked Elidel and Protopic to about 25 cases of cancer in adults and children who used the drugs. Protopic and Elidel have become widely prescribed as an alternative to steroid creams, which have long term side effects.

On January 20, 2005 the FDA declared that Protopic will have to bear a "black box" warning indicating possible cancer risks. The new labeling also will clarify that the drug be recommended for use only after other prescription topical medicines have been tried by patients. The agency is also issuing a guide updating patients about these risks and concerns. A black box warning is the most serious type of warning in prescription drug labeling. The warning will be located lower on the labels of the two drugs than is typical, although a statement higher on the labels will refer to the risk. As of October 2004, the FDA had received reports of 78 cases of cancers, including skin and lymphoma, in patients treated with both Protopic or Elidel, said Dr. Stanka Kukich, the acting director of the FDA's dermatologic and dental drug products division.

If you or a loved one took Protopic and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>