At a meeting of the FDA’s Pediatric Advisory Committee today, potential label changes will be considered for Eli Lilly’s antipsychotic drug Zyprexa. The Committee will evaluate whether new warnings are necessary about the risk of potential Zyprexa side effects for children, such as severe weight gain, hyperglycemia or other metabolic effects.
Zyprexa (olanzapine), is an atypical antipsychotic medication that has been used by more than 26 million people worldwide.
It is manufactured and marketed by Eli Lilly & Co., and was first approved in the United States in 1996 for treatment of schizophrenia and bipolar disorder in adults. It has also been widely prescribed off-label for other unapproved uses, such as treatment of dementia and mild forms of bipolar disorder.
Although Zyprexa is only approved by the FDA for use by those 18 years or older, it is commonly prescribed off-label to children, and Lilly has been seeking approval to market the drug for children between 13 and 17 years of age.
In documents released in advance of the advisory meeting today, FDA staffers suggested that new language should be considered to specifically warn about the potential side effects of Zyprexa for children. This could include information about the risk of weight gain and other metabolic changes that are already noted on the label for adults.
As a result of Lilly’s failure to adequately warn about these side effects in the past, the drug maker has already paid about $1.2 billion to settle over 30,000 Zyprexa lawsuits filed by users who suffered diabetes, hyperglycemia, pancreatitis and other injuries.
Lilly has also paid millions to settle claims over their marketing practices, which included claims that they marketed the drug for unapproved uses and downplayed the risk of Zyprexa side effects.
According to the New York Times, Eli Lilly is also expected to pay at least another $1 billion in restitution and fines to resolve federal criminal investigations related to their marketing of Zyprexa.
At the Pediatric Advisory Committee meeting on November 18, 2008, independent panel of experts will also consider potential side effects of Lamisil for children. According to the same FDA staff review documents, Novartis’ antifungal drug has been associated with a risk of psychiatric side effects in children, including cases of depression, suicidal thoughts and self-harm.
The Best Pharmaceuticals for Children Act of 2002 requires drug reviews for all drugs recently tested in children. The FDA advisory panel consists of outside experts who will discuss the reports and make recommendations to the FDA about adding warnings to the drug labels about potential side effects in children.