The FDA is Investigating the Possibility of a Ritalin-Cancer Association

In late June 2005 it was widely reported that the FDA was examining a potential link between Ritalin and cancer.  What did not get the same degree of press coverage was that the researchers who first pointed out this possible Ritalin-cancer link had emphasized that their finding was preliminary.  Further, these researchers have made clear that their preliminary finding should not be cause for any panic.

Ritalin, which entered the market in 1955, is a stimulant that has been used to treat attention-deficit hyperactivity disorder (ADHD) for decades.  The recent findings by researchers from the M.D. Anderson Cancer Center at the University of Texas, which showed damage to the chromosomes of 12 children who had taken Ritalin for three months, came to light during an FDA pediatrics advisory committee meeting held on June 30, 2005.  The principal focus of that advisory committee meeting had been to discuss whether the class of ADHD medications known as methylphenidates — to which Ritalin belongs — had any psychiatric side effects.

Essentially, the M.D. Anderson researchers said their Ritalin study was far too small to prompt doctors, or parents of ADHD patients, to abandon the drug.  The study first appeared in the Feb. 16 online issue Cancer Letters.  These researchers have submitted a grant proposal to the National Institutes of Health seeking funds for a larger study which would include more patients and consider additional ADHD drugs.

In connection with the M.D. Anderson study findings, The New York Times reported on July 1, 2005 that FDA officials "are examining millions of health records to determine if children who took Ritalin decades ago now have higher rates of cancer."  Further, the Times reported that the FDA has asked the makers of ADHD stimulant medications like Ritalin, i.e., methylphenidates, to provide the FDA with any information they might have about their respective drug’s effects on chromosomes.

About 29 million prescriptions were written last year in the U.S. for Ritalin and other ADHD drugs; 23 million of those prescriptions were for children. The ADHD drugs are among the most widely prescribed medications in the world.  In fact, there is an increasing amount of controversy in the U.S. and elsewhere about the use of ADHD drugs, with critics often saying that the ADHD drugs are vastly over-prescribed.

Almost 2 million children in the United States have been diagnosed with ADHD, according to the National Institute of Mental Health.

(Posted by: Tom Lamb)