Drugs meant for treatment of Attention Deficit Hyperactivity Disorder (ADHD), Ritalin (Novartis AG) and Adderall (Shire Pharmaceuticals) would be subjected to stringent clinical trials to assess the safety and side effects of the drug.
The decision has been taken following the reports of the U.S. advisory panel, which stated that strong warnings should be associated with marketing of such drugs. There is a possibility of sudden death, heart attacks and other complications associated with the use of the drug.
The company officials have expressed keen interest in evaluating the relationship between these drugs and cardiovascular risk, taking into consideration the physicians and affected patients. The company would also support disclosure of all information, including the warning statement.
Data from the prospective clinical trial is believed to be very crucial in deciding whether the drug should carry a black box warning. The black box warning is issue to a prescription drug that is related to dangerous side effects. When surveyed, 7 of the 8 panel members recommended a black box warning for the drug.
The drug Adderall, marketed by Shire already carries a black box warning, highlighting the possibility of sudden death or cardiovascular complications. More than 1 million ADHD prescriptions are being written for adults while children receive nearly 2 million prescriptions every year.
The ADHD drugs closely resemble amphetamines in chemical composition, known to cause hypertension, a significant predisposing factor for heart disease. With more clinical trials being planned, it would not be long before the safety of Adderall can be established.