Analysis: Heat Intensifies on ADHD Drugs
Posted on: Wednesday, 22 March 2006, 00:00 CST
By TODD ZWILLICH
Popular drugs used to treat attention-deficit/hyperactivity disorder face continued scrutiny this week as regulators look at whether the drugs increase the risk of cardiovascular and psychiatric side effects.
Outside advisers to the Food and Drug Administration are set to hold hearings tomorrow on reports linking several stimulant drugs to strokes and heart attacks. The committee will also help decide whether labels warning users of cardiovascular risk and even an increased risk of suicidal thoughts and psychosis are strong enough.
A separate committee last month surprised FDA officials by recommending stark black-box warnings on stimulant ADHD drugs including Adderall, Ritalin and Concerta. Experts said then that the strong warnings were necessary to inform the public and physicians about possible drug risks.
The FDA has received about 20 reports of sudden deaths in adults and children taking Adderall, the most popular stimulant medication for ADHD. Those reports spurred the Canadian government to order the drug's extended-release formulation off of pharmacy shelves last February. The drug was returned to the market over the summer with new safety warnings.
More than 4 percent of children and adolescents -- an estimated 2.5 million in total -- take stimulant drugs for ADHD. Those patients will be the focus of hearings tomorrow and also Thursday, when experts will look at reports of psychiatric side effects in the yet-to-be-approved drug Sparlon.
FDA officials were quick to disagree with last month's surprise recommendation by its panel of drug experts. Wednesday's hearing is before the agency's advisory committee for pediatric drugs, which the companies hope will focus more on the drugs' benefits for diagnosed children than on the risks.
A preliminary FDA study of 675,000 patients last month found 49 cases of heart attacks in children and adolescents who had taken ADHD drugs. That's compared with 12 attacks expected in that age group, based on national health data.
In adults, 732 heart attacks were observed where only 218 were expected, and 401 strokes occurred where 164 were expected.
FDA scientists stressed that the findings were preliminary, but said that they showed that stimulant drugs for ADHD needed further study.
Though they were preliminary, the data gave significant pause to a majority of the 15-member FDA advisory panel last month. Eight experts voted to urge the agency to apply new warnings in light of the estimated 1 million stimulant prescriptions written for adults each month.
I want to cause people's hands to tremble a little bit before they write that (prescription). The only way I know how to do that is to put it in a black box, Steven Nissen, a panel member and Cleveland Clinic cardiologist, said last month.
The label for Adderall XR, the market-leading drug, warns that misuse can lead to cardiovascular side effects. Matthew Cabrey, a spokesman for Adderall manufacturer Shire Pharmaceuticals, said in an interview Tuesday that the company believes the existing label carries adequate safety warnings, though the current warning does not mention increased risk with recommended use.
Our label already has a black box talking about the risk of cardiovascular and sudden deaths. That's why we feel so strongly that the current label is appropriate, he said.
On Thursday, experts are expected to review 31 cases of childhood suicidal behavior, aggression or psychosis in clinical trials of Cephalon's new drug Sparlon.
Company spokesperson Sheryl Williams said the hearing will give officials a chance to discuss adverse events in light of what the firm sees as an enormous benefit potential for the drug.
We have our day on Thursday to talk about both sides of the drug, efficacy and safety, she told United Press International.
Experts are also scheduled to hear FDA reports of a rapidly growing U.S. market for ADHD drugs, which some could interpret as a sign of overprescription. The ADHD market for adults has nearly doubled in the past four years.
Cabrey said this week's pediatrics panel will focus more than last month's committee on balancing the benefits of Adderall and other ADHD drugs with risks.
Generally folks will feel more comfortable about the fact that there are more diverse medical professionals assembled on the panel who can appropriately review all of the benefits and risks, he said.
Source: United Press International
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