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Quick Hits: Voluntary Recall of Some Valsartan Lots, Cryotherapy Risks, France Recalls Breast Implants

 

By Sarah Rosenthal

January 4, 2019

Quick Hits: Medication Recommended for Women at High Breast Cancer Risk, FDA Committee Supports Gout Drug & More

Aurobindo Pharma USA has voluntarily recalled 80 lots of Amlodipine Valsartan, a blood pressure and heart failure medication. Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP have all been removed from the consumer-level of sale. Trace amounts of N-nitrosodiethylamine (NDEA), a known carcinogen, were detected in the tablets, possibly due to a manufacturing error. While NDEA can be found in certain foods, drinking waters and forms of pollution, it is still dangerous to the public. The FDA recommends that patients currently using the medication not stop taking it without a viable substitute, as this could cause more danger than the medication itself. Posted December 31, 2018. Via FDA.

Controversy surrounding the issue of whole-body cryotherapy in spas and gyms became more intense after a 71-year-old man suffered from stinging pain and redness resulting in blisters when a nozzle malfunctioned. Whole-body cryotherapy is on the rise as a new health trend, although not backed by scientific evidence and not approved by the FDA. Cryotherapy is generally used for small dermatological procedures such as freezing off a wart, but the whole-body version has been promoted as an aid for sore muscles, back pain and skin problems, among other issues. The treatment involves submerging the body (from the neck down) in a liquid nitrogen mist at temperatures ranging from -150 degrees F to -220 degrees F (-100 C to -140 C) for several minutes. Posted January 1, 2019. Via Reuters.

The French equivalent of the FDA, the National Agency for Medicines and Health Products Safety, has asked Allergan to voluntarily recall its line of textured breast implants due to increasing reports of leakage linked to a type of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Textured breast implants make up 85% of the French market and are used for both cosmetic and reconstructive surgeries. So far, over 600 cases of BIA-ALCL have been reported worldwide, and 16 women have died. Sales have already been suspended in 33 countries due to the company’s failure to meet European Union health, safety and environmental standards. In the US, the FDA issued a statement saying: “We have been in contact with French regulatory authorities to discuss the issue.” The agency is meeting in 2019 to review the safety of all breast implants. Posted December 18, 2018. Via NBC News.

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Last updated: January 3, 2019