ANALYSTS: ADHD DRUG SALES UNLIKELY TO DIP DUE TO ADVISORY WARNING
An FDA advisory panel recommendation to put a black box warning on several attention deficit/hyperactivity disorder (ADHD) drugs should not affect sales of the products, analysts say.
The FDA's Drug Safety and Risk Management Advisory Committee recently voted 15-0 to require a medication guide warning patients about cardiovascular and other health risks. The committee also voted 8-7 with one abstention to add the black box warning to stimulant ADHD drug labeling. The FDA is not required to follow advisory panel recommendations, but usually does.
After the meeting, FDA officials were noncommittal regarding the recommendation. They suggested a black box warning was unlikely due to the inconclusive nature of the data and lack of established causality. While the FDA believes it should tell people about possible risks based on available data, "overstatement can do active harm," said Robert Temple, director of medical policy in the Center for Drug Evaluation and Research's Office of Drug Evaluation I.
Furthermore, it could take up to one-and-a-half years to get the data necessary to determine the cardiovascular risks of ADHD drugs, the FDA advisers acknowledged.
Industry analysts also were not convinced the agency would issue a black box warning. "We believe that the FDA's immediate concern level with the products is low and see black box as unlikely," said Merrill Lynch analyst Graham Parry in a Feb. 10 note. "A medication guide is more likely because of the strong panel vote in its favor," he said.
Even if the FDA does require a medication guide or black box warning, it should not affect stimulant ADHD drug sales, Parry added, since: Prescribing doctors already know that stimulant ADHD drugs increase the risk of sudden death in patients with cardiovascular problems, and the information is already on product labels; there is no data definitively linking stimulant ADHD drugs and sudden death; and when warnings were added to stimulant ADHD drug labels, they did not have a noticeable effect on prescription growth or market share.
Over the past year, ADHD drugs have been linked to hypertension, chest pain, arrhythmia and tachycardia, among other conditions. Concerns also have been raised about links between the drugs and sudden unexplained deaths, strokes and various psychiatric events, including reports of abnormal behavior, aggression, anxiety, depression and suicidal thoughts.
Specifically, the panel called for black box warnings on methylphenidate-based ADHD drugs, including GlaxoSmithKline's Ritalin, Johnson & Johnson's Concerta (methylphenidate HCl), Mallinckrodt's Methylin (methylphenidate HCl) and UCB's Metadate (methylphenidate HCl). The panel also called for warnings on amphetamine-based ADHD drugs, including Shire Pharmaceutical's Adderall and Adderall XR (amphetamine aspartate/amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine sulfate).