Off the Market: Why Has Your Drug Been Suspended?
If the medication you take is withdrawn from the market, it can feel as if someone pulled the rug out from under you. It's been working for you, you don't have side effects, and you've gotten used to it. So why would a drug no longer be available?
Such was the case in Europe with the diabetes drug rosiglitazone (Avandia), which was withdrawn from the market there and will be sold here in the U.S. only under new restrictions.
When a drug like rosiglitazone is taken off the market, it means that the authorities decided that the risks outweighed the benefits for most patients. In this case, the federal Food and Drug Administration and the European Medicines Agency felt that the cardiovascular risks simply outweighed the health benefits for most patients taking the drug.
Here in the U.S., diabetics will only be able to continue taking it if their doctors can justify their decision to give them the drug. And in order to continue to take rosiglitazone, patients will be required to sign a statement that they are aware of the risks.
"The FDA is very concerned about the side effects from some of these drugs," says Loren Wissner Greene, MD, an endocrinologist at NYU Langone Medical Center in New York City. "Fortunately, if a drug is withdrawn from the market, it's not as bad for a patient with diabetes as it would have been five years ago."
That's because there's a whole new slew of diabetes drugs on the market, Greene explains, and the FDA now requires pharmaceutical companies to conduct trials on new diabetes drugs to investigate any possible cardiovascular effects.
While it can be scary to consider staying on a drug that could cause health problems, it's also important not to panic every time you see something on the news about a drug that is going to be pulled off the market.
What's the best course of action? Never stop taking a drug without checking with your doctor, says Novelette Thompson, MD, of the Holy Cross Medical Group in Fort Lauderdale, Florida. Very often, it's possible to take something comparable, but when the patient decides to stop a drug on his own, it could result in poor blood sugar control.
"Often there's a drug in the same class that a person can switch to," she says. "But the doctor will make that decision."
At the same time, Thompson adds, bear in mind that the drug that's being restricted still may work for you. In the case of rosiglitazone, for instance, "It's a decision for the doctor and patient to make together," Thompson says. "Some patients may be doing just fine on the drug."
But, Thompson added, knowing that the drug has been restricted may make the patient nervous about continuing to take it.
And this should not be taken lightly, she says. "Patients should feel comfortable with their decision to stop or to continue with a drug," Thompson says.
Stein, Rob. "Regulators Apply Brakes on Avandia." American Diabetes Association. 24 September 2010.
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