FDA requires new drug labeling

INDIANAPOLIS -- Federal regulators have asked the makers of a widely-used class of six antipsychotic drugs to include labeling language about a possible link with diabetes, Eli Lilly & Co. said Wednesday.\nLilly's antipsychotic Zyprexa is the company's top-selling drug, accounting for about one-third of the company's sales. It is also the category's top seller.\nThe Food and Drug Administration's request, made in a letter received this week by the drugs' producers, follows several recent studies exploring a possible diabetes link. Label warnings already have been required for some of the drugs overseas.\nFDA spokeswoman Susan Cruzan said the agency frequently makes requests for additional drug labeling. Cruzan added she was unaware of any enforcement steps the FDA might take in case a company does not comply, which she said rarely occurs.\n"It is in their interest to put the information in the labeling," Cruzan said.\nThe other drugs that fall under the FDA's labeling request are: Bristol-Myers Squibb's Abilify, Pfizer's Geodon, Novartis' Clozaril, Janssen's Risperdal and AstraZeneca's Seroquel.\nThe FDA letter recommends patients using the so-called atypical antipsychotics be monitored for blood-sugar abnormalities, particularly if they have risk factors including obesity and a family history of diabetes.\nBristol-Myers Squibb was "working quickly to respond to the FDA" regarding Abilify, company spokeswoman Tracy Furey said.\nThe FDA's labeling request "levels the playing field among all atypical antipsychotics" in the debate about a possible diabetes link, said analyst Robert Hazlett of SunTrust Robinson Humphrey.\nHe predicted any impact on the drugs' sales would be minor.\nU.S. sales of the six leading antipsychotics totaled $5.4 billion in the 12-month period ending Aug. 31, with 22.7 million prescriptions written, according to NDCHealth, a health care research company. Zyprexa was the top seller, with nearly $2.4 billion in U.S. sales.\nZyprexa has come under pressure because of the emergence of newer rivals Geodon and Abilify.\nZyprexa has been singled out by some in the diabetes controversy because of its well-documented link to weight gain in some patients.\nThis year, Lilly also became the target of product-liability lawsuits that attempt to link Zyprexa with life-threatening and fatal cases of diabetes. The San Francisco-based firm Hersh & Hersh has filed five such lawsuits.\nLilly spokeswoman Marni Lemons said the company was in discussions with the FDA regarding the new labeling.