FDA: J&J's Risperdal and Lilly's Zyprexa Are Over-Used in Kids

Johnson & Johnson and Eli Lilly can expect their atypical anti-psychotics to take a sales hit in light of some FDA officials’ desire to see their use curbed in children. An FDA panel yesterday rejected the FDA’s proposed routine monitoring of the safety of anti-psychotics in children and instead discussed stronger language on their labels and active discouragement of doctors using the drugs on children, particularly for off-label treatments such as ADHD. Some bullet points from the meeting:

• More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger.
• [The FDA said] far more needed to be done to discourage the medicines’ growing use in children, particularly to treat conditions for which the medicines have not been approved.
• Prescription rates for the drugs have increased more than fivefold for children in the past decade and a half, and doctors now use the drugs to settle outbursts and aggression in children with a wide variety of diagnoses, even though children are especially susceptible to their side effects.

Although J&J’s Risperdal and Lilly’s Seroquel take most of the heat in the NYT article, it also applies to AstraZeneca’s Seroquel, Bristol-Myers Squibb’s Abilify, and Pfizer’s Geodon.

The news will come as vindication to critics of antipsychotic use in children. For years these folks have complained about tests done with tiny sample sizes by researchers who have obvious conflicts of interest.

J&J said there was nothing wrong with its drug labeling.

Photo of a baby’s straitjacket from Flickr user endora57.