ADHD drug promotions don't tell you the whole story

Have you seen the recent ads and promotions for ADHD drugs? The ones that claim the drugs can help counter drug or alcohol abuse or help kids who have attention deficit hyperactivity disorder perform better in school?  Some of the promotions even fail to make it clear the drugs can cause dangerous side effects, like sudden death in those with heart abnormalities.

The Food and Drug Administration wants the ads and promotions out of the public eye. In late September the FDA sent warning letters to five drug companies to stop their campaigns: Shire for Adderall XR, Johnson & Johnson for Concerta, Novartis for Focalin XR, Mallinckrodt for Methylin, and Eli Lilly for Strattera.

An estimated 5 to 8 percent of school-aged kids in the US have ADHD. While the drugs used to treat the condition are generally effective and safe, they can in rare cases cause serious side effects, such as death and psychiatric disturbances. But in terms of how effective the drugs are, the ads in question go too far by claiming they can reduce problems that could arise from untreated ADHD, like poor school and job performance, social problems, and drug and alcohol abuse, the FDA said in its letters.

The agency also took the companies to task for not clearly explaining, or sometimes even mentioning, the potential dangerous side effects of the drugs. A YouTube ad, featuring Ty Pennington, host of the TV show "Extreme Makeover: Home Edition," didn't cite any risks associated with Adderall XR. And the patient brochure that comes with Methylin failed to disclose warnings that the drug can cause sudden death in patients with heart abnormalities, suppress growth temporarily, or trigger visual disturbances.

The FDA faulted the promotional material for Strattera for claiming that two side effects—stomach upset and drowsiness—can occur when the treatment is started, but then go away. The FDA said it was not aware of any data to suggest that these side effects are temporary.

The FDA has requested that all these promotions be pulled because they violated regulations governing pharmaceutical advertisements. The violations for Adderall XR and Strattera were considered to be so serious that the FDA ordered the two companies that produce the drugs to come up with a plan to tell those who got the misleading materials the truth about those products.

For a free and unbiased report about ADHD drugs that can help you sort out the hype from the facts, read our Consumer Reports Best Buy Drugs report on ADHD medicines. Subscribers can also get our ratings of ADHD treatments.

—Steve Mitchell, associate editor, Consumer Reports Best Buy Drugs