Healthy Skepticism Library item: 11634

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Lilly’s Zyprexa on 'deadly drugs' list
PMLive.com 2007 Oct 1
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6042

Full text:

A study conducted by the Institute for Safe Medication Practices and the Division of Public Health Sciences at Wake Forest University School of Medicine has found that Zyprexa has one of the highest rates of suspect drug deaths, ranking thirteenth on the list of drugs with the most reported deaths and adverse events.

Over the eight years of the study, Zyprexa was linked to 1,005 deaths and 4,110 adverse events. The information was posted on the FDA’s Adverse Event Reporting System and was published in the Archives of Internal Medicine in September.

An atypical antipsychotic, Zyprexa is approved to treat schizophrenia and bipolar disorder. Literature about the drug for medical professionals notes that suicide attempts are “inherent to schizophrenia and bipolar disorder”, however.

Zyprexa posted FY06 sales of USD 4.4bn and is Lilly’s best-selling product. It has, however, also caused huge legal problems. Lilly has paid more than USD 1bn to settle tens of thousands of patient lawsuits claiming the company failed to disclose that Zyprexa causes weight gain, diabetes complications and other health problems.

Several states are suing Lilly, claiming it marketed Zyprexa for off-label uses, including treatment of adolescents, dementia, depression and autism, without warning about its risks.

Since Zyprexa was launched in 1996, it has been prescribed to about 20 million people around the world. The drug loses patent protection in 2011.

In late September 2007, a three-member FDA team initially urged rejecting the drug for paediatric use because of inconsistent data from studies in US and Russian teens.

In a 29 April 2007 memo posted on the FDA’s website, Thomas Laughren, head of the agency’s psychiatry division, said the drug’s benefits in some studies outweighed the reviewers’ concerns.