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FDA Warns Pfizer Over Geodon Study

Apr 21, 2010 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) issued a warning to drug maker Pfizer Inc over a number of “failures” that resulted in overdoses in no less than 13 children, said Reuters. The overdoses occurred during Pfizer’s clinical trial of Geodon, an antipsychotic medication; the letter was made public yesterday.

We’ve been following the issue of psychotropic drugs and pediatric patients for some time, especially regarding efficacy and safety. Last June we wrote that an FDA vote was scheduled for three psychotropic medications and their safety and efficacy for children with specific conditions, including Geodon. At that time, the Wall Street Journal reported that the agency said the medications effectively treat some psychiatric disorders in pediatric patients, but come with serious risks, including sedation and weight gain.

Earlier this month, the FDA issued a warning letter to Pfizer saying it “failed to ensure proper monitoring” of the trial, said Reuters, noting that some children experienced “tremors, restless legs, and other complications.” Pfizer, the world’s largest drug maker, is looking to market Geodon to pediatric bipolar disorder patients, added Reuters.

Many experts are concerned that psychotropic medications, which are generally prescribed in the adult population for the treatment of depression, schizophrenia, and bipolar disorder, might not work in the same way when taken in children and teens, whose brains are still developing, said Reuters.

Reuters previously reported that drug reviewers recommended regulators conduct additional studies into the effects of these drugs on children. According to FDA staff, said Reuters previously, an emerging health insurance claim study revealed that children treated with psychotropic medications “were much more likely to experience an adverse metabolic effect than adults, and the likelihood was directly correlated with age.” Such effects include “abnormal weight gain, diabetes, and increases in cholesterol and blood pressure,” said Reuters.

The FDA letter said that Pfizer did not appropriately monitor the study and, “as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner,” and said its letter came after repeated violations about which Pfizer was notified in 2005, quoted Reuters.

Meanwhile, we also recently reported that doctors and hospitals were paid a whopping $35 million by Pfizer in the second half of last year. According to The Wall Street Journal, the payments to about 4,500 hospitals and doctors, were for the research and promotion of Pfizer drugs. Reuters explained that Geodon was first approved in 2001 for adults with schizophrenia and has since been cleared for the treatment of bipolar disorder in adults.

Pfizer’s new disclosure effort comes just months after the drug maker struck an agreement with the U.S. Department of Justice to pay $2.3 billion to settle claims arising from the illegal marketing of some drugs, including Geodon. Among the charges covered by the settlement were allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe this, as well as other, drugs.

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