Black Box Warnings

With at least two million children and one million adults being prescribed ADHD medication every month, the Food and Drug Administration advisory panel voted 8-7, with one absentee, in favor of a “black box” warning to be put on Ritalin and other stimulant drugs. This was after hearing about the 25 deaths, 19 of which were children, that occurred while on AHDH medicine. One committee member believes that not disclosing the uncertain risks while taking these drugs is unethical.
Although it usually does, the FDA is not required to follow recommendations given by the advisory committee. The FDA also believes that the committee just wants a more forceful, informative warning label on methylphenidates, such as Ritalin and Concerta. Since 2004, there has been black box labels on Adderall and Adderall XR, which are the same type of drugs.
Novartis, the company who has been making Ritalin since 1955, says that after reviewing fifty years of records, they’ve found no increase in cardiovascular problems among their patients. And they point out that their drug already has a caution label advising against use for those with pre-existing heart conditions.
Some believe that a black box warning will help the out of control growth of ADHD drugs. Besides the 25 deaths reported between 1999 and 2003, the council also discovered there were 54 cases of cardiovascular problems, which included heart attacks, strokes, and hypertension.
Opponents of this vote say that they’ve found fewer than one death or injury for every 1 million prescription filled. They also say that the reports don’t warrant regulatory action. They feel that the agency’s analysis only suggests a possible link between the drugs and cardiovascular problems, and they want more answers.