No cause for alarm: ADHD meds have long record of safety

Last Friday, February 10, 2006, headlines reported "Warnings advised on ADHD drugs." A 15 member advisory committee recommended (by a vote of 8-7) to the FDA that a black box be added to the labeling of stimulants used to treat ADHD. Concern about serious cardiovascular side effects is mainly due to the report of a small number of sudden deaths in kids and adults who were taking stimulants. The biggest problem with this proposal is … There is no good scientific evidence that incidence of these very serious events is any greater in patients taking stimulants than in the general population. Last February, Health Canada (Canadian equivalent of FDA) took Adderall off the market because of a similar concern. (see 2-14-05 Blog) But further study of the facts led them to put it back on the market a few months later. A reanalysis of all the facts last year by the FDA found no convincing evidence of serious risk. Adderall XR already carries a black box warning that abuse or misuse could cause serious side effects. The label also warns of possible risk of sudden death in patients with structural cardiac abnormalities. Advanced arteriosclerosis, moderate to severe hypertension (especially if not controlled), and hyperthyroidism are contraindications for use of amphetamines. When trying to decide whether to take a medication, ask two important questions: What are the benefits? What are the risks? In my opinion, based on over 30 years of experience, the benefits far outweigh the potential risks. Stimulants are clearly the most effective treatment for ADHD. Untreated ADHD markedly increases alcohol and drug abuse, reckless driving accidents, lost jobs, divorce, stress, and reduced self-esteem. We have 70 years of research and clinical experience with stimulants. Taken under medical supervision, any risk of serious side effects is extremely small. I feel confident that Shire, McNeil, and other pharmaceutical companies that market stimulant medications will keep us informed of any new information or cause for concern. In the meantime, I continue to believe these medications are safe. Links Shire press release, 2-10-06 statement

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