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Friday, April 23, 2010

FDA Claims Pfizer Failed to Fix Problems in Testing Procedures

The FDA has recently issued a warning letter to Pfizer, informing them that they are not properly monitoring physicians testing an experimental medication. Pfizer has experienced problems with their testing protocol since 2006, resulting in overdoses for more than two dozen patients participating in the trial.

According to a Pfizer spokeswoman, the drug being studied is called Geodon. It is being tested for use with children who have bipolar disorder.

In 2006, 26 patients participating in clinical trials of the drug received an overdose. Three more patients overdosed in 2007. When the FDA inspected Pfizer's testing in July 2009, they found the pharmaceutical company was still not following its own safety guidelines for the testing of this drug. In particular, clinical investigators were not being made aware of new dosing issues that would arise.

Pfizer responded to the 2009 FDA complaint, but according to the FDA's most recent warning letter, the pharmaceutical company did not clearly outline the steps they would take to prevent future problems during clinical testing. Pfizer has 15 business days to submit a plan for correcting these problems to the FDA.

If you or a loved one has been seriously injured as a result of taking a dangerous drug, you may be entitled to receive compensation for your damages. The experienced defective drug attorneys at The Cochran Firm have the resources and experience needed to take on pharmaceutical companies who sacrifice the safety of patients in favor of increased profits.

Please contact our defective drug attorneys today to schedule your free initial consultation. The Cochran Firm serves clients nationwide.

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posted by Benjamin A. Irwin at 10:55 AM

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