FDA skeptical about Zyprexa data

After causing a string of side effects since its introduction in 1996, Zyprexa, one of the most commonly used atypical antipsychotics, the U.S. Food and Drug Administration (FDA) is investigating whether its manufacturer, Indiana-based Eli Lilly & Company, provided accurate data about the safety of the drug.

However, while the global leader in pharmaceutical, Eli Lilly & Company lays stress on providing complete prior information and data to FDA, an article in the New York Times accuses the company of concealing facts about the clinical trail of the drug.

According to The New York Times, FDA closely following the case is questioning Eli Lilly & Co. about its February 2000 document that found patients taking Zyprexa in a clinical trial were three and a half times more likely to develop high blood sugar than compared to a placebo.

However, the document was not filed with FDA, and later a report showing almost no difference in blood sugar changes was submitted with FDA by Eli Lilly.

In response, Eli Lilly clarifies that the document was a preliminary analysis, and a final quality check of the data found that the analysis was incorrect.

"The known side-effects of Zyprexa had been reported extensively and that the FDA had been provided with all the data," underlined Angel Perez-Agenjo, Eli Lilly director for Denmark and Iceland.

Approved by the FDA for the treatment of schizophrenia, acute mania in bipolar disorder and as maintenance treatment in bipolar disorder and psychotic depression., the drug use reported extensive side effects of obesity and its tendency to raise blood sugar, two known risk factors for diabetes.

Lilly’s top-selling drug with sales of $4.2 billion last year, demand for Zyprexa waned in the United States amid concerns of its weight gaining tendencies.

Meanwhile, a Senate is scheduled to vote next week on a series of reforms.

The agenda includes necessitating pharmaceutical manufacturers to register and make public the results of clinical trials of drugs. Also, authorizing FDA to undertake label changes and post-market safety studies to monitor drug safety once the drug hits market.