Find a Lawyer in Your State

Need Help?

Yesterday, a Food and Drug Administration pediatric advisory panel voted against recommending a “black box” warning for popular attention deficit hyperactivity disorder drugs like Novartis AG''s Ritalin and Shire Plc''s Adderall.

The federal advisory committee did, however, recommend clarifying the language on the drug label to make it easier for doctors, patients, and parents to understand the potentially dangerous side effects.

“I wouldn''t use the word ‘tougher,''” said panel chairman Robert Nelson in reference to the decision about the new ADHD drug labels. “Clearer.”

In February, the FDA asked an advisory panel on drug safety and risk management to evaluate the possible cardiovascular side effects posed by ADHD drugs.

This month, the agency requested a pediatric panel to assess the same issues of heart risks, as well as examine the recent reports of the link between ADHD drugs and psychosis in adolescence taking normal doses of the medication.

The pediatric committee''s decision went against the other federal panel''s recommendation last month that ADHD drugs should carry the strongest type of FDA warning of the cardiovascular and psychiatric risks posed by the use of the medications.

The FDA is not obligated to follow the recommendations of its advisory committees, but usually does. The panel''s decision casts doubt whether the FDA will issue “black box” warnings on ADHD drugs.

Psychiatrists insisted the committee be extremely cautious before voting for stronger warnings of the dangers linked to the use of ADHD drugs such as heart attacks and symptoms of psychosis including hallucinations because in many cases, the benefits outweigh the risks of the drugs.

According to Medco Health Solutions Inc., a drug benefit program, almost three and half million Americans under the age of 19 used ADHD medications last year.