Blogs Contact Us for a Free Consultation Restless Legs Drugs Need Black Box Warnings, FDA Hears

Law360, New York (June 15, 2017, 7:03 PM EDT) By Jeff Overley Several drugs for restless legs syndrome should get black box warnings that emphasize the risks of impulse-control disorders and other side effects, an industry-backed research company told the U.S. Food and Drug Administration in a petition released Wednesday. The citizen petition from California-based…

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Janssen Pharmaceuticals’ Diabetes Medications Invokana and Invokamet Will Now Require Black-Box Warnings

Shared from Law360, New York (May 16, 2017, 6:29 PM EDT) — The U.S. Food and Drug Administration on Tuesday said it has confirmed that Janssen Pharmaceuticals’ diabetes medications Invokana and Invokamet can increase the risk of patients needing to have their legs or feet amputated and said the drugs will now require black-box warnings. The agency…

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Nearly 1/3 of All FDA Approved Medications Pose Safety Risks Identified Only After Approval

The Washington Post (5/9, McGinley, 11.43M) recently reported on a study published in the Journal of the American Medical Association suggesting that “almost a third of drugs cleared by the Food and Drug Administration pose safety risks that are identified only after their approval.” 222 products were reviewed that had been approved between 2001 and…

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