FDA Issues Serious Warning

While the May 2016 FDA safety announcement cautioned that this new safety issue with the diabetes drug is still under investigation, interim results suggest that amputations occurred about twice as often in patients treated with SGLT2 inhibitors like Jardiance or Farxiga compared to patients treated with a placebo.

The preliminary data from the clinical trial found that seven in 1,000 patients taking SGLT2 inhibitors required amputations compared to three in 1,000 patients taking a placebo.

Are You Taking Jardiance or Farxiga?

The SGLT2 inhibitors approved by the FDA include Eli Lilly & Co’s Jardiance, as well those from Bristol-Myers Squibb, Astra Zeneca Plc, Merck & Co and Pfizer Inc.

Patients taking Jardiance or Farxiga should notify their health care professionals immediately if they notice any new pain or tenderness, sores or ulcers, or infections in their legs or feet. However, the FDA added that patients should not stop or change their diabetes medicines without first consulting their prescriber, as doing so may lead to uncontrolled blood sugar levels, blindness, nerve and kidney damage, and heart disease.

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Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.

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