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FDA Approves Boxed Warning on Xeljanz (Tofacitinib)

Xeljanz FDA Warning

The US Food and Drug Administration approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis.

This new warning, issued July 26, 2019, comes just a few months after the first warning issued February 25, 2019.

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Blood Pressure Medication Recall Expanded

Blood Pressure Med Recall

Torrent Pharmaceuticals is recalling an additional 36 lots of Losartan potassium tablets and 68 lots Losartan potassium/hydrochlorothiazide tablets. This is the fourth expansion of the original recall posted in December 2018 of blood pressure medications manufactured by the company.

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FDA Orders Two to Stop Selling Pelvic Mesh, Citing Safety Concerns

FDA in magnifying glass

Surgical mesh has been used to treat hernias since the 1950s. In the 1970s, gynecologists began using it for abdominal repair of pelvic organ prolapse (POP) and in the 1990s for the transvaginal repair of POP.

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FDA’s Hidden Reports on Medical Devices

FDA Hidden Reports

March 8, 2019. In an article published by Kaiser Health News, we learned that some medical device manufacturers have been using a secret reporting mechanism to let the FDA know of problems with their devices.

The problem? The data is hidden so that neither the public nor doctors are aware of any problems reported.

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Essure Device: FDA Safety Oversight after Discontinuation of US Sales

Essure FDA Oversight

December 20, 2018. FDA Commissioner, Scott Gottlieb, issued a statement on the new steps the FDA will take to strengthen the long-term safety oversight of Essure.  In his statement, Gottlieb said the FDA will continue to evaluate the product’s long-term safety profile even after it has been discontinued in the US market.

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FDA to Overhaul Medical Device Review System

FDA Overhaul of System

“Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices.”

On Monday, November 26, 2018, the Food and Drug Administration announced that it plans to modernize its current process, the 510(k) clearance pathway, which is how a majority of the medical devices are reviewed and approved by the FDA today.

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Zimmer Biomet Receives FDA Warning Letter

FDA Warning Letter Zimmer Biomet

On August 24, 2018, Zimmer Biomet received a Warning Letter from the FDA regarding quality violations found during 2016 and 2018 inspections at a facility in Warsaw, IN.

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Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices

FDA Market Approval

FDA Letter to Health Care Providers

Posted by the FDA on April 25, 2018.

The Issue: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

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FDA Restrictions Placed on Essure

Essure FDA Restrictions

Permanent birth control is one of the most widely used methods of contraception today. It can be highly effective, doesn’t require a surgical procedure and women no longer have to remember to take a daily pill. So why has the FDA restricted the sale and distribution of the Essure device and required boxed warnings?

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FDA 510(k) – aka, Substantially Equivalent

FDA Pre-market approval

Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.

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