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FDA

Fast-Track FDA Drug Approvals Leads to Deadly Drugs Entering Market

Thursday, January 08, 2009 by: David Gutierrez, staff writer
Tags: FDA, health news, Natural News


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(NaturalNews) Drugs that receive FDA approval right before deadline are more likely to cause serious side effects than those approved with more time to spare, according to a study published in the prestigious New England Journal of Medicine.

"The article is a wake-up call," said renowned cardiologist Steven Nissen, who was not involved in the study. "It puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines. We've got to reevaluate now whether that's good public policy."

In order to speed up the rate at which new medicines hit the market, Congress has imposed strict deadlines by which the FDA must approve or reject a drug. But critics have charged that this policy encourages the FDA to rush to approve drugs without being sure that they are safe.

The researchers said that over the last few decades, drugs approved just before the deadline were between four and five times as likely to require serious safety warnings or be withdrawn from the market.

Drugs withdrawn from the market included diabetes drug Rezulin, which caused liver problems; cholesterol drug Baycol, which caused muscle damage; painkiller Vioxx, which increased the risk of heart attacks and strokes; and painkiller Bextra, withdrawn for similar reasons. Another drug approved just before deadline was the diabetes drug Avandia, which later had its label revised to warn of severe heart risks.

The researchers also found that a drug was 3.4 times more likely to be approved within two months of the deadline than at any other time in the approval process.

"FDA staffers by their own admission feel very much under the gun as these deadlines loom," said study co-author Jerry Avorn of Brigham and Women's Hospital in Boston. "If they're forced to make decisions prematurely, they may not make the right decisions. That needs to be debated openly."

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