Yourlawyer.com (Strattera News)

ADHD drugmakers must tell of risks

Fri, 23 Feb 2007 00:00:00 -0800

Federal officials told the makers of Ritalin, Adderall, Strattera and all other drugs for treatment of attention deficit hyperactivity disorder, or ADHD, on Wednesday to come up with new pamphlets to explain the potential risks of the drugs to patients and parents.

The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and chewable versions.

The panels made the recommendation after reviewing reports of young children hearing voices or having hallucinations while on the medications, some reporting they could see snakes or bugs or worms, and there were other reports of heart complications, including sudden death.

An agency review found a slightly increased risk, about one per 1,000 patients for adverse psychiatric reactions. A separate review of reports of serious cardiovascular adverse events found reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

The new patient guides would supplement the information already included on the drugs' labeling and would be given out in booklet or pamphlet form with each prescription.

Dr. Mark Epstein, a specialist in the treatment of ADHD and medical director of the Miami Children's Hospital Dan Marino Center in Weston, Fla., said the concerns first surfaced about two years ago and that he got calls from many parents of his patients who take the drugs.

"Parents are very scared when they hear about a risk for sudden death," Epstein said. But after he explained that the risk is no higher for children on the drugs than for the general population, and that the deaths occurred in patients with known heart problems or a family history of such problems, only one or two parents insisted their children be taken off the drugs, he said.

"When the appropriate diagnosis is made and the medications are prescribed properly, they are exceedingly safe," Epstein said, but he recommended that patients and parents talk with their own doctors if they have concerns.

ADHD affects an estimated 3 percent to 7 percent of school-age children and about 4 percent of adults. The three main symptoms are inattention, hyperactivity and impulsivity.

Government wants further ADHD drug warnings

Thu, 22 Feb 2007 00:00:00 -0800

The makers of Ritalin, Adderall, Strattera and other drugs treating attention-deficit hyperactivity disorder were advised by the government Wednesday to give patients and their parents an additional warning that those medicines could cause serious psychiatric and heart problems, including sudden death.

Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart or psychiatric problems, such as chest pain, shortness of breath, fainting or hallucinations.

Dr. Thomas Laughren of the Food and Drug Administration emphasized that the move was precautionary and should not frighten patients away from taking the drugs, which he said were safe. He expected the manufacturers of the 15 drugs to comply with the request within 30 days.

An estimated 3.3 million children and 1.5 million adults take ADHD drugs, whose sales exceed $3.5 billion a year. Their use has been dogged by concerns about overuse in children and side effects, prompted by scattered reports of children dying suddenly. Some of the children were later determined to have had heart defects.

The latest action expands upon a move the government made last year, when the FDA asked manufacturers to revise ADHD drug labels to alert prospective patients with heart problems and warn of hallucinations in one out of 1,000 children.

Dr. Richard L. Gorman, a pediatrician who served on an FDA advisory panel that recommended the ADHD drug warnings, said the medication guides were "in line with" what the committee recommended. Gorman said parents must pay close attention to their children's reactions to the drugs because children might take them for years.

Laughren said it took until now to work out the wording of the medication guides, which are more simply worded than drug labels. Companies may tweak the language that the FDA proposed, he added.

More than 2,500 children who took ADHD drugs went to emergency rooms in 2004, and about a quarter of them had serious heart or blood pressure problems, the Centers for Disease Control and Prevention reported last year. Twenty-five deaths, 19 involving children, linked to the drugs were reported to the FDA from 1999 to 2003. Fifty-four strokes, heart attacks and other heart issues were also reported; some of those patients had previous heart conditions.

ADHD drug makers to warn of side effects

Wed, 21 Feb 2007 00:00:00 -0800

Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday's announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

Drug makers to add warnings to ADHD pills

Wed, 21 Feb 2007 00:00:00 -0800

Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

ADHD Drugs to Get New Warnings

Wed, 21 Feb 2007 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) announced today that it is ordering all manufacturers of attention deficit hyperactivity disorder (ADHD) medication to develop Patient Medication Guides to warn patients of potentially serious side effects. The most significant warnings will be related to adverse psychiatric symptoms and to cardiovascular risks.

“Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,” said Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research (CDER). “In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns.”

According to the agency, “An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors. Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.”

In May of 2006, the FDA’s Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee directed the drug makers to revise their label warnings, and the new directive for Patient Medication Guides is the next step in that process. There are 15 medications subject to the new warnings: Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin Oral Solution, Methylin Chewable Tablets, Ritalin, Ritalin SR, Ritalin LA, and Strattera.

The FDA says that approximately 3 percent to 7 percent of children and 4 percent of adults suffer from ADHD, which has three main symptoms: inattention, hyperactivity, and impulsivity. They recommend that any patient considering using any of these drugs “develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).”

According to drafts of the medication guides posted on the FDA’s website, the warnings include information about adverse events including “heart-related problems” and “mental (psychiatric) problems.” The heart-related problems cited include sudden death in patients who have heart problems or heart defects; stroke and heart attack in adults; and increased blood pressure and heart rate. The psychiatric problems facing all patients include new or worse behavior and thought problems; new or worse bipolar illness; and new or worse aggressive behavior or hostility. For children and teenagers, there are added warnings about new psychotic symptoms (such as hearing voices, believing things that are not true, unfounded suspicion) or new manic symptoms.

FDA orders warning 'guides' for ADHD drugs

Wed, 21 Feb 2007 00:00:00 -0800

Pharmacists will soon begin handing out consumer-friendly "medication guides" about cardiovascular and psychiatric problems linked to widely prescribed attention deficit/hyperactivity disorder drugs, the Food and Drug Administration announced Wednesday.

Tom Laughren, director of the FDA's Division of Psychiatry Products, said makers of the 15 products approved to treat ADHD have 30 days to finalize the language in the medication guides. Meanwhile, drafts written by the FDA are posted online at www.fda.gov/cder/drug/ infopage/ADHD/default.htm.

About 3% to 7% of school-age children and about 4% of adults have attention disorders, the FDA says. In 2006, U.S. sales of ADHD drugs totaled about $3.5 billion, according to IMS Health, a health care information company.

Laughren said the new guides reflect changes ordered last May in the warnings section of the drugs' physician labeling. Two FDA advisory committees a year ago recommended adding information about new data on cardiovascular and psychiatric problems in children and teens who took the ADHD drugs.

From 1993 to February 2005, the FDA received 27 reports of unexpected death in patients under 18 who had taken one of the medications, Laughren said. It's not clear whether the deaths were the result of the ADHD drugs or underlying cardiovascular problems, he said.

In addition, since 2000 the agency has received hundreds of reports of psychosis or manic behavior, particularly hallucinations, in patients who had no known risk factors, according to an agency memo given last year to one of the advisory committees.

Also, a pooled analysis of trials that compared an ADHD drug with a placebo found a higher rate of hallucinations, delusions and mania in patients who were given the medication, Laughren said, putting the risk for such problems at one in 1,000 patients.

"Despite this new warning language in the medication guides; we continue to view ADHD as an important illness that benefits from treatment," Laughren said.

FDA Directs ADHD Drug Manufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Event

Wed, 21 Feb 2007 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) today directed the manufacturers of all drug products approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient Medication Guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms associated with the medicines, and to advise them of precautions that can be taken.

"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

Adderall (mixed salts of a single entity amphetamine product) Tablets
Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
Concerta (methylphenidate hydrochloride) Extended-Release Tablets
Daytrana (methylphenidate) Transdermal System
Desoxyn (methamphetamine HCl) Tablets
Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
Focalin (dexmethylphenidate hydrochloride) Tablets
Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
Methylin (methylphenidate hydrochloride) Oral Solution
Methylin (methylphenidate hydrochloride) Chewable Tablets
Ritalin (methylphenidate hydrochloride) Tablets
Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
Strattera (atomoxetine HCl) Capsules

ADD Drug Strattera, Already Under FDA Scrutiny, Raising New Safety Concerns in UK as Well

Tue, 21 Feb 2006 00:00:00 -0800

Although pharmaceutical giant Eli Lilly (Lilly) continues to maintain that its attention deficit drug, Strattera, is safe, the company’s actions as well as those of the FDA would seem to indicate quite the opposite.

On September 28, 2005 for example, Lilly declared it was adding a black-box warning to Strattera. That warning advises that the drug may increase suicidal thoughts among youths.

FDA officials said Eli Lilly must also create a medication guide for patients and healthcare providers pertaining to the new black box warning. Black box warnings are the most prominent and serious of medication warnings.

The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.

Strattera has also been linked to liver problems. In 2004, Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage.

Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera's label to include the serious liver side effects.

In December of last year, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.

"The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug," Laughren said.

In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and Adderall in response to reports of serious psychiatric side effects in patients taking Concerta and Ritalin. Some ADHD drugs are also associated with cardiovascular side effects.

In what many experts are viewing as an unusual turn of events, an FDA advisory panel, in January of this year, voted (8-7-1) to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.
This new controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children.

In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications. (Adderall is the only non-stimulant ADD drug).

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.
The FDA has attempted to back off from the unexpected action by the panel by issuing a statement that it would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA's Center for Drug Evaluation and Research. He stated: "The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm."

Thus, Temple indicated the full FDA would wait for the recommendation of a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.

Now comes word that Strattera is faring no better in the UK in light of these safety concerns well as the possibility that the drug is also associated with seizures and a potentially dangerous lengthening of the interval between heartbeats.

According to IndyStar.com, the Tacoma (Washington) News Tribune, and Reuters, the “warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency. The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released in that country.

“Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and it warned doctors and consumers that the drug should be used with caution in people prone to such problems.

“In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.”
Although British authorities still believe the drug’s benefits outweigh its risks, they are updating the drug's label in that country to warn of the possible problems. Presently, no warnings regarding the seizure risk are contained in the U.S. labeling. The heart problem risk, however, was inserted in the 25-page U.S. label in January at the request of the FDA.

British raise issues with ADHD drug

Tue, 21 Feb 2006 00:00:00 -0800

British authorities are raising safety concerns about Strattera, the attention deficit hyperactivity disorder drug made by Indianapolis pharmaceutical company Eli Lilly and Co.

The drug already has been linked to rare cases of liver damage and suicidal thoughts and behaviors.

British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002. The warnings are based on an internal report by the British Medicine and Healthcare Products Regulatory Agency, the United Kingdom's equivalent to the U.S. Food and Drug Administration.

The report, which has not been made readily available to the public, was obtained by The News Tribune after a Swedish court ordered it released in that country.

Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and it warned doctors and consumers that the drug should be used with caution in people prone to such problems.

In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.
British authorities are updating the drug's label in that country to warn of the possible problems. Overall, though, the agency concluded Strattera still offers more benefits than risks.

Lilly spokeswoman Jennifer Bunselmeyer said Monday that the company works closely with regulatory bodies around the world, monitors their findings and updates drug labels accordingly.

"There is a wealth of data demonstrating Strattera's safety," she said.

No warnings are planned at the moment to U.S. doctors and patients, and the U.S. label for Strattera contains no warning of seizures. At the FDA's request, Lilly inserted a five-word note about the "very rare" heart problem on Page 17 of the drug's 25-page label in January.

FDA to probe ADHD drug safety

Thu, 05 Jan 2006 00:00:00 -0800

The US Food and Drug Administration is planning to review the cardiovascular risks of attention-deficit hyperactivity disorder treatments, and has asked an advisory panel to discuss the issue at a meeting on February 9-10.

The move follows reports of sudden deaths, strokes, heart attacks and high blood pressure in both children and adults taking drugs to treat ADHD, according to the agency.

Last June, the FDA announced an investigation into the safety of ADHD products based on the stimulant drug methylphenidate, including Johnson & Johnson's once-daily Concerta product, and said it was considering extending the review to include all ADHD treatments on the market. But the agency was subsequently advised to hold back on any label changes until it was established whether the reported side effects were common to all drugs in the class.

"The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks," said the FDA. The Drug Safety and Risk Management Advisory Committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.

Use of ADHD drugs is expanding rapidly in the USA, according to a report published last year by pharmacy benefits company Medco. Prescribing swelled 23% among young adults (aged 20-34), with a 40% in the amount spent on these prescriptions, while use older adults also climbed, up 33% in adults aged 39-49 and 36% in those aged 50-64.

FDA to examine new ways to study ADD drugs

Wed, 04 Jan 2006 00:00:00 -0800

Reports of sudden deaths, strokes, heart attacks and hypertension in both children and adults taking drugs to treat attention deficit hyperactivity disorder are spurring new government study into the medications’ safety.

Sales of drugs to treat ADHD have increased sharply in recent years, with use growing at a faster rate among adults than children, according to a recent study by Medco Health Solutions, a prescription benefit manager. Spending on ADHD drugs soared from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm.

The Food and Drug Administration said it had received reports of what it called “serious adverse events” including deaths in association with the therapeutic use of the drugs. The agency considers the reports “rare though serious,” FDA spokeswoman Susan Bro said Wednesday.

The FDA’s Canadian counterpart, Health Canada, yanked the ADHD drug Adderall XR from the market for six months last year in response to reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects.

The panel eventually concluded there was inadequate evidence of increased harm from Adderall XR compared with other available therapies a conclusion the FDA also reached based on data on hand.

Now the U.S. regulatory agency is asking its Drug Safety and Risk Management advisory committee to examine ways of studying further the potential cardiovascular risks of the drugs. The few studies that have looked at longer-term use of ADHD drugs provide little information on those risks, the FDA said.

“It almost sounds like cox-2 inhibitor redux,” said committee chairman Dr. Peter Gross, referring to cox-2 painkillers like Vioxx and Bextra pulled from the market because of evidence they can raise the risk of a heart attack or stroke.

The committee is to meet Feb. 9 and 10 in Gaithersburg, Md.

“The issue of drug treatment of attention deficit disorder in children has been a controversial one without this issue of cardiovascular risk too. It adds another concern to what will certainly be an interesting conversation,” said Arthur Levin, the FDA committee’s consumer representative.

A posting to the FDA Web site did not identify any of the drugs by name. However, the most commonly used ADHD drugs include Adderall XR, made by Shire Pharmaceuticals, and Ritalin, made by Novartis Pharmaceuticals Corp. Various other companies make generic versions of Ritalin as well.

Shire spokesman Matthew Cabrey said the company hadn’t been told of the meeting but added it may send representatives. Novartis did not immediately return a call seeking comment.

The committee’s Feb. 10 meeting will include updates on FDA actions on cox-2 drugs as well as a recently begun patient, doctor and pharmacist registry program for the anti-acne drug Accutane and its generic competitors.

Separately, the committee also will discuss the FDA’s Drug Safety Oversight Board, an internal, government employee-only panel created nearly a year ago.

The board is supposed to monitor FDA-approved medicines once they’re on the market and update physicians and patients with emerging information on risks and benefits.

Gross said he had concerns about the board’s impartiality and independence, as well as its relationship to his committee and the very similar work it does.

Lilly Agrees to Add Warning On Strattera Labeling

Fri, 21 Oct 2005 00:00:00 -0700

A pharmaceutical maker volunteers to add a black-box warning noting rare occurrences of suicidal thoughts in young patients taking its popular ADHD drug.

Eli Lilly and Co. announced September 29 that it was complying with a request from the U.S. Food and Drug Administration (FDA) to add a "black-box" warning to the product labeling for atomoxetine (Strattera).

The added language will focus on "uncommon reports of suicidal thoughts among children and adolescents" taking the drug. In conjunction with the action, the FDA issued a Public Health Advisory and updated its online "Healthcare Professional Information Sheet" for the drug.

Atomoxetine, a selective norepinephrine reuptake inhibitor (SNRI), is approved in the United States for treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children aged 6 and older.

In separate statements, both Lilly and the FDA said that the action was taken as a result of the company's submission of an "analysis of adverse-event data from its Strattera clinical-trials database that identified a small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents" compared with patients in those trials taking placebo.

The FDA also requested that Lilly develop a medication guide for patients and caregivers.

The FDA has no statutory authority to require specific labeling or medication guides. Rather, it is limited to requesting action from a drug manufacturer and normally must negotiate final labeling language with the company. If a drug maker does not agree with the agency's request, the FDA has the option to declare the product under discussion "misbranded" and begin legal proceedings that could result in the product's removal from the market. That process is cumbersome, however, and has rarely been used.

The director of the FDA Center for Drug Evaluation and Research, Steven Galson, M.D., characterized the action as "another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe manner." Yet, in this instance, the option of adding a black-box warning to the atomoxetine label was suggested by Lilly itself when it submitted data from 12 clinical trials involving approximately 2,200 children and adolescents.

The data were requested by the FDA (and other regulators around the globe) as part of an ongoing review of safety data relating to psychiatric medications. Specifically, the agency asked Lilly for data on "possibly suicide-related" adverse events occurring in any of the placebo-controlled trials of atomoxetine. Suicide-related adverse events include both suicidal thoughts and behaviors.

Lilly submitted the dataset to the FDA and other regulators on September 15. The company also submitted two analyses of the adverse-event data. Data from 12 pediatric trials were submitted (eight involving patients who had only ADHD, the others involving patients with ADHD and comorbidities such as major depression or anxiety). Nine trials of the drug in adults were submitted, three concerning ADHD and six involving major depression.

Of the 2,200 children and adolescents studied, 1,357 received the drug, and 851 received placebo. Five "possibly suicide-related" cases were identified in patients taking atomoxetine (0.37 percent), and no cases appeared in those taking placebo. A sixth case was identified and classified as a suicide attempt in a patient taking the drug. All of the cases represent spontaneously reported adverse events. None of the clinical trials' protocols appear to have used standardized measurements of suicidal thinking or behavior.

According to the Centers for Disease Control and Prevention, 17 percent of adolescents think about suicide a year. Among high school students, 12 percent of girls and 5 percent of boys attempt suicide a year. Ultimately, 2 per 100,000 girls and 12 per 100,000 boys die as a result of such attempts. In the United States, this translates into approximately 2,000 young people who die as a result of suicide.

Overall, pediatric patients taking atomoxetine were deemed to be about 2.5 times more likely to have a "possibly suicide-related" event than those who took placebo. A Lilly meta-analysis of suicide-related behaviors in the placebo-controlled atomoxetine studies showed that of six events, five involved suicidal ideation, while only one involved actual suicidal behavior.

Of these events, all occurred in males under age 12. There were no completed suicides.

The Lilly analysis further noted that the "number needed to harm" for suicidal ideation was 271 for all pediatric patients in the clinical trials.

That is, 271 patients would have to be given atomoxetine before one patient would experience a "possibly suicide-related" event. In contrast, only four patients would need to receive medication to have one pediatric patient experience a remission (defined as greater than or equal to a 40 percent reduction in the ADHD Rating Scale total score).

Analysis of the nine adult trials showed no increased risk of "possibly suicide-related" events.

Other regulatory agencies announced similar updates to approved product labeling in their jurisdictions, including Canada, the European Union, and Australia. In Canada, the warning will appear similar to that in the United States, as a boxed, bolded warning in the product labeling.

In most countries of the European Union, the information will appear under the "Special Warnings" section of the label. However, the United Kingdom's Medicines and Healthcare Products Regulatory Agency said it is "looking into the health risks and benefits of [atomoxetine]," and new labeling may be announced soon. In Australia, the new warning will appear as a "Precaution."

ADHD Drug, Straterra, May Cause Suicidal Thoughts

Thu, 29 Sep 2005 00:00:00 -0700

Eli Lilly & Company is warning that its ADHD drug, Straterra, may cause suicidal thoughts in children and adolescents.

In a press release dated today, Lilly reported that its Straterra clinical trials database had identified a small but statistically significant increased risk of suicidal thoughts among Straterra-treated children and adolescents. Out of 1357 children, there were five reported cases of suicidal thoughts, versus none in a group of 851 patients taking a placebo.

While there was also one case of a suicide attempt in the 1357 patients, no deaths were reported, and there was no indication of an increased risk of suicidal thinking in the adult population.

The FDA has an ongoing review of psychiatric medicines, and requested the clinical trial data from Lilly. The analysis of the data was based on criteria developed by Columbia University and the FDA last year.

Dr. Alan Brier, chief medical officer at Lilly said “While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician.”

ADHD affects between three and seven percent of school-age children, and about four percent of adults in the United States. Symptoms include distractibility, impulsivity, and a lack of attention and concentration.

According to a recent Center for Disease Control (CDC) study, ADHD is diagnosed more often in boys, and is diagnosed less often in minority children. A report published by the Consumers Union finds that while stimulant drugs are effective, they are probably being prescribed to many children who do not have the disorder.

Lilly plans to add a boxed warning to the product label and is working with the FDA to finalize the updated information that it will send to healthcare professionals and world wide regulatory agencies.

FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder

Mon, 29 Aug 2005 00:00:00 -0700

The Food and Drug Administration (FDA) today is issuing a Public Health Advisory to alert physicians of reports of suicidal thinking in children and adolescents associated with Strattera, a drug approved to treat attention deficit hyperactivity disorder (ADHD).

FDA has also directed Eli Lilly and Company, manufacturer of Strattera, to develop a Medication Guide for patients and caregivers.

FDA is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed (either increased or decreased). Patients and caregivers who have concerns or questions about these symptoms should contact their healthcare provider.

"FDA's action today is another example of the agency acting swiftly to alert the public to significant drug safety information needed to use a drug in a safe manner," said Dr. Steven Galson, Director for the Center for Drug Evaluation and Research, FDA.

Today's actions follow a review and analysis of 12 clinical trials conducted in children with ADHD and one trial in children with enuresis (bedwetting) that identified an increased risk of suicidal thinking for Strattera. There was one suicide attempt by a patient who received Strattera among the approximately 2,200 patients in the trial.

As part of a larger evaluation of psychiatric drugs and suicidality, FDA had requested that the manufacturer conduct a review of its database and clinical trials, which included more than 2200 patients, 1350 patients receiving Strattera (atomoxetine) and 851 receiving a placebo. The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking compared to no cases in children treated with the placebo.

Strattera, manufactured by Eli Lilly, has been on the market since 2002 and has been used in more than two million patients.

FDA ISSUES WARNING TO ELI LILLY WITH RESPECT TO TELEVISION AD FOR STRATTERA, A DRUG USED TO TREAT ADHD (ATTENTION DEFICIT HYPERACTIVITY DISORDER)

Fri, 17 Jun 2005 00:00:00 -0700

In a letter to Eli Lilly, the FDA has warned the pharmaceutical giant that its television advertisement for Strattera “is false or misleading because it inadequately communicates the indication for Strattera and minimizes the risk associated with Strattera.”

The FDA found, that in addition to minimizing the drug’s risks, the ad was misleading in that it suggests a broader indication for the drug as a treatment for ADD (Attention Deficit Disorder) a somewhat similar, but nonetheless medically different condition from ADHD.

The ad clearly depicts behavior which is typically associated with ADD. A voiceover also specifically refers to Strattera as a treatment for adult ADD. Currently, the drug is only approved as a treatment for ADHD. Although Lilly disagrees with the warning, it has already pulled the ad from television.

LILLY ADDS WARNING TO STRATTERA LABEL

Mon, 20 Dec 2004 00:00:00 -0800

Eli Lilly and Co. announced it has added a bolded warning to the product label for Strattera (atomoxetine hydrochloride) regarding two reported cases of severe liver injury.

The warning states that the drug, which is used to treat attention-deficit/hyperactivity disorder, should be discontinued if patients develop jaundice or laboratory evidence of liver injury.

There has been no evidence of liver injury in the approximately 6,000 patients who have participated in Strattera clinical trials, the company said. However, of the more than 2 million patients treated during the first two years after the drug was approved, there have been two reported cases of markedly elevated hepatic enzymes and bilirubin in the absence of other clear explanatory factors, the company said. Both patients recovered with normal liver function after Strattera was discontinued.

The company said in a small proportion of patients, severe drug-related liver injury could lead to acute liver failure, need for a liver transplant or death.

Pruritus, dark urine, jaundice, upper-right side abdominal tenderness or unexplained flu-like symptoms could be signs of liver dysfunction. If patients notice these symptoms, they should contact their physicians and undergo laboratory testing to determine liver enzyme levels.

Shares of Lilly closed at $56.02, down $1.38, or 2.4 percent, in heavy trading on the New York Stock Exchange.

Strattera to Get New Risk Label

Sat, 18 Dec 2004 00:00:00 -0800

Strattera, used to treat attention-deficit hyperactivity disorder, is getting an updated label to highlight the risk the drug might contribute to severe liver problems in some patients.

The government said yesterday the warning says the medication should be discontinued in patients who develop jaundice or laboratory evidence of liver injury.

"The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients," the Food and Drug Administration said in a statement.

The updated labeling follows reports of liver problems in an adult and a teenager who had been treated with Strattera for several months. Both recovered, the FDA said, and it offered no other details of the cases.

Strattera has been dispensed to more than 2 million patients since it went on the market in 2002. No sign of liver problems was seen in the drug's clinical trials, which involved 6,000 patients, the FDA said.

Eli Lilly & Co., the manufacturer, agreed to alert doctors about the risk by sending them a letter, an updated insert for patients in the drug package and a boldface warning on the label, the FDA said. The company confirmed it was taking those actions.

Strattera is among a new generation of attention-deficit drugs that require only a morning dose, a boon to schools where children have had to take second doses of medication in the afternoon. Normally, the main side effects are reduced appetite and growth.

The FDA said the package insert explains some of the signs of possible liver problems, including jaundice, dark urine, unexplained flulike symptoms, upper right-side abdominal tenderness and a form of itchy skin known as pruritus.

Eli Lilly Off on Drug Label Warning

Fri, 17 Dec 2004 00:00:00 -0800

Eli Lilly shares fell Friday after the company said it has added a bolded warning to the product label for Strattera, its treatment for attention deficit/hyperactivity disorder, or ADHD.

The company said the warning states the medication should be discontinued in patients with jaundice or laboratory evidence of liver injury. Lilly said the label change is the result of two reported cases of severe liver injury out of the more than 2 million patients who have taken the medication since approval. Both patients have recovered with normal liver function after discontinuing the medication.

Lilly said it had "worked closely" with the Food and Drug Administration "to determine the best course of action, and as a result, are taking a number of measures to notify health care professionals and ultimately patients."

The drugmaker stressed that the 6,000 patients taking Strattera in clinical trials did not show liver injury. "Real-world reports indicate that Strattera can cause severe liver injury in rare cases," the company said.

ADHD affects 3% to 7% of school-age children and manifests itself in levels of attention, concentration, activity, distractibility and impulsivity that are inappropriate for the age group, according to the company's news release.

Shares fell $2.04, or 3.5%, to $55.36.

Strattera Liver Disease Side Effects Lawsuit

Fri, 17 Dec 2004 00:00:00 -0800

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Injured by Strattera?

Eli Lilly declared on September 28, 2005 that they are adding a black-box warning to its attention deficit (AD) medication Strattera. The new warning will claim that the drug increase suicidal thoughts among youths. The FDA issued a health advisory on Strattera after evaluating clinical trial data submitted by Eli Lilly. This FDA’s finding prompted Eli Lilly to update Straterra’s label.

FDA officials said Eli Lilly must also have to create a medication guide for patients and health care providers pertaining to the new black box warning. Black box warnings are the most prominent of medication warnings. Dr. Thomas Laughren, director of the FDA's division of psychiatry products, said in December the federal government requested Lilly to assess 13 clinical trials conducted on children to measure a suicide risk.

"The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four (case) per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug," Laughren said. The FDA said Lilly submitted results from a Strattera clinical trial of 1,357 youths taking the medication that found five of them had increased suicidal thoughts, while none of 851 youths taking a placebo showed such changes. Lilly said one youth attempted suicide during its Strattera trials, but that researchers saw no signs of increased suicidal thoughts among adults.

Strattera (Generic: Atomoxetine hci), Eli Lilly's popular drug to treat attention deficit disorder (ADD), has been linked to liver problems. Recently, Eli Lilly warned doctors to stop prescribing Strattera in patients with jaundice or who show signs of liver damage. Eli Lilly warned that Strattera can cause severe drug related liver injury that can progress to acute liver failure resulting in death or the need for a liver transplant. In December 2004 the FDA updated Strattera's label to include the serious liver side effects.

Strattera is the only non-stimulant medication approved by the FDA for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. Strattera is a norepinephrine reuptake inhibitor, a class of ADHD treatment that works differently from the other ADHD medications available. Strattera has been prescribed to over 2 million patients since it was approved in 2002.

In June 2005, the FDA announced it will be investigating all attention deficit hyperactivity disorder drugs including Strattera, Ritalin, Concerta, and Adderall in response to reports of serious psychiatric side effects in patients taking Concerta and Ritalin. Some ADHD drugs are also associated with cardiovascular side effects.

On January 3, 2006, the Food and Drug Administration asked its standing committee of risk-management advisers to review reports of heart-related complications in children and adults using attention deficit disorder drugs. U.S. and Canadian regulators have been looking in the past few years at the probable heart risk of attention-deficit drugs, which are stimulants used to improve concentration.

An approximate 2 million patients, both adults and children have been prescribed Strattera since it was granted FDA approval.

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