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Drug safety: FDA, doctors must weigh the risks

New York consumers may wonder about the safety of taking certain drugs, even if prescribed by their doctor, when they hear about drug warnings, recalls and lawsuits over a drug with unintended patient results. You may be surprised to learn that the federal government's Food and Drug Administration has no power to initiate a drug recall. The agency can issue alerts and warnings, as it has recently with the diabetes medication canagliflozin (Invokana and Invokamet), but recalls must be made by the manufacturer. A typical consumer's reaction might be something like, "Why was this drug approved in the first place?" But the answer is complicated.

Drugs must gain FDA approval before they can be sold in the U.S. The makers first must conduct lab and animal tests to learn how it works and if it is likely to perform well and safely in people. If they deem it promising, drug makers will then perform clinical trials. These test results go next to the FDA's Center for Drug Evaluation and Research, where they undergo independent review by a team of specialists that includes physicians, pharmacologists, chemists and additional scientists. If the group determines that the benefits outweigh the risks, the drug receives approval.

After approving the diabetes drug in 2013, the FDA issued a safety alert following new clinical trials that showed amputations of the foot and leg occur at double the rate in patients taking canagliflozin versus a placebo. It warned diabetes patients taking the drug to watch for developing pain, sores or infections in the legs and feet and to consult their doctor immediately if they had these symptoms. It also warned physicians that, before prescribing the drug, they should consider these factors in patients that could make it more likely they would require amputations.

The drugs have not been recalled by the manufacturer and are still being prescribed if doctors consider it appropriate for their patient. Just as the FDA panel must weigh the risks versus the benefits of a drug, your doctor must do the same.

If you have concerns about any medications, consult your doctor as soon as possible. It may not be safe to just discontinue the drug, so be sure to speak with your physician first.

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