PEDIATRIC ALERT

July 14, 2005

Do Stimulant Medications Increase Adult Cancer Risk?

Federal health officials are looking into suggestions from a small Texas study that methylphenidate (Ritalin and others) and other stimulants may increase children's later risk of cancer. The statement came as part of an FDA Advisory Committee meeting focused on adverse event reports associated with the long-acting form of methylphenidate, Concerta.

The committee found nothing unusual about the nature or frequency of those reports, but an FDA official noted that product label descriptions of possible side effects of various stimulants were often written in technical language, so the FDA will ask for clearer statements of these effects.

As to the possible carcinogenicity of stimulants, experts from the FDA, NIH, and EP A went to Texas at the end of May to examine the methods used by University of Texas and M.D. Anderson researchers, which found damage to the chromosomes of 12 children who took Ritalin for three months. While carcinogenic drugs can cause similar chromosomal changes, an FDA official reported that there were flaws in the methods used (including the absence of a control group); however, the allegations were not being dismissed.

Larger studies, with controls, are being mounted, and medical record data will be searched to see if there is any epidemiologic evidence to support this recent finding. At present, federal officials said there was no reason for children currently taking Ritalin or other stimulants to stop taking those medications. (Harris G: New York Times, Jut] 2005)

COMMENT: Since stimulants (especially Ritalin) are often fodder for newspaper headlines about their possible risks, we suspect that parents might have heard about this report, with a likely ramp-up in their anxiety levels. As best the committee and the FDA could judge, there's not much to this small and uncontrolled experiment, and certainly not enough evidence to warrant changes in treatment choices. Perhaps in the old days (a couple years ago) this finding would have been largely ignored; in the current climate, however, following a number of controversial actions (or inactions) by the FDA, this finding will be given considerable attention, so stay tuned.

Prescriber's Letter

August 2005

ADHD

People are hearing about potential safety concerns with Concerta...due to reports of adverse effects. These reports include hallucinations, suicidal thoughts, and psychotic or violent behavior. Also hypertension, arrhythmias, and chest pain.

It's too soon to say if these effects are specific to Concerta...or if they apply to ALL methylphenidate or ADHD drugs. An underlying cause may have triggered these reactions.

The FDA is reviewing psychiatric and cardiovascular effects with all ADHD meds...including amphetamines and Strattera. If you suspect a serious reaction due to Concerta or another ADHD drug, go to our Detail-Document for a link to FDA’s MedWatch