Healthy Skepticism Library item: 8503

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Publication type: news

FDA handling of Lilly drug needs probe--scientist
Reuters 2007 Feb 13
http://yahoo.reuters.com/news/articlehybrid.aspx?type=comktNews&storyID=urn:newsml:reuters.com:20070214:MTFH63942_2007-02-14_00-06-23_N13215157&pageNumber=0&imageid=&cap=&sz=13&WTModLoc=HybArt-C1-ArticlePage2

Full text:

WASHINGTON, Feb 13 (Reuters) – U.S. lawmakers should investigate the Food and Drug Administration’s handling of side effects linked to Eli Lilly and Co.‘s (LLY.N: Quote, Profile , Research) antipsychotic medication, Zyprexa, an agency whistle-blower said on Tuesday.

FDA scientist Dr. David Graham told a congressional hearing the drugmaker and the agency knew “for a long time” about the risk of weight gain from Zyprexa that could trigger diabetes.

While such side effects were eventually added to the drug’s prescribing instructions, Graham testified it was not clear how the agency handled the information or made the decision to alter the label.

“FDA did its typical dragging its feet on post-marketing safety issues,” he told Reuters after the U.S. House of Representatives Energy and Commerce subcommittee hearing.

Graham did not review Zyprexa, but said that, after his 2004 public testimony criticizing the FDA’s actions on Merck & Co Inc.‘s (MRK.N: Quote, Profile , Research) withdrawn Vioxx painkiller, other agency staffers came to him with concerns.

The FDA had no specific comment on Zyprexa, which is approved to treat schizophrenia and bipolar disorder.

“The assessment of the safety of any drug, including Zyprexa, should be viewed as an ongoing process,” the agency said in a statement.

Lilly said it has worked closely with the FDA about Zyprexa’s side effects since it was approved in 1996. Doctors have also been given information about the possible risks.

“The relationship between Zyprexa … use and diabetes is not completely understood,” the company added.

Other antipsychotic medications also warrant closer scrutiny, Graham told lawmakers without naming specific drugs. He also said he would submit a list of other types of prescription drugs with safety concerns that the committee should investigate.

Antipsychotics include Bristol-Myers Squibb’s (BMY.N: Quote, Profile , Research) Abilify, Novartis AG’s (NOVN.VX: Quote, Profile , Research)(NVS.N: Quote, Profile , Research) Clozaril, Lilly’s Symbyax, AstraZeneca Plc’s (AZN.L: Quote, Profile , Research)(AZN.N: Quote, Profile , Research) Seroquel, Johnson & Johnson’s (JNJ.N: Quote, Profile , Research) Risperdal and Pfizer Inc.‘s (PFE.N: Quote, Profile , Research) Geodon, among others.

Such drugs are increasingly being given for unapproved uses to nursing home patients with dementia and similar mental disorders, which can double the risk of death, he said.

Although the FDA does not regulate the use of medicines once they are approved, Graham called the problem a “public health issue.”

Representatives for the other drugmakers either had no comment on the hearing or could not be reached.