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Before a new drug can be prescribed, it must be approved by the FDA. To approve a drug, the FDA requires clinical trials to establish that a high enough percentage of the people who took it, benefited in the way they were supposed to.
Regardless, not all approved drugs turn out to be good for patients. The best example is Vioxx, manufactured by Merck and approved by the FDA in 1999. It was quickly popular with patients as an effective pain reliever.
But Vioxx was removed from the market in 2004 when the FDA estimated more than 27,000 Americans had died from taking it. Lawsuits followed. Eventually Merck paid $4.85 billion to settle claims – a fraction of the amount they made from the drug in those five years.
The penalty for Merck was a piece of its profits. The penalty for those patients was death.
Vioxx is only one example of a drug that, despite FDA approval, turned out to be dangerous. In 2010, Avandia, a diabetes drug, and Meridia, a weight-loss drug, were removed from the market. Avastin may lose its approval for breast cancer. Drugs and devices are under review constantly.
Unfortunately, years may pass between the time a new drug is made available for prescription writing, and the realization that it creates a danger to the patients who take it. So what happens to patients who take them in the interim? How can we know if they are safe?
We can’t. Which is why it makes sense to prevent possible problems to begin with.
Do a background check on any drugs you are prescribed to determine when the FDA approved them. (http://bit.ly/FDAOrangeBook) Drugs approved within the last five years require a deeper review.
If problems have been reported, or notices or warnings have been issued for a drug, you can find that information in a section of the FDA website called Postmarket Drug Safety Information (http://bit.ly/FDADrugSafety).
Tap into the power of other patients, too. Other patients tend to voice concerns long before the FDA provides information to the public. Search for online support groups for your diagnosis, and see whether they are talking about the drug you’ve been prescribed.
If you identify potential problems with the drug, return to your doctor to explain your findings and concerns. Discuss alternatives if they exist, and pros and cons if they don’t.
It’s a great way to partner in the decision-making about drug prescriptions, their safety and ability to help you. |
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