Recent safety communications published by the US Food and Drug Administration indicate that type 2 diabetes drug, Invokana (canagliflozin), can cause increased risk for foot and leg amputations. This announcement was made after data from two clinical studies showed that such amputations were necessary in nearly twice as many patients taking Invokana as compared to patients taking a placebo. As…
The Food and Drug Administration has announced that those who undergo breast augmentation using breast implants have an increased risk for developing anaplastic large cell lymphoma—a rare form of non-Hodgkins lymphoma. According to safety communications, the FDA identified a possible link between the implants and anaplastic large cell lymphoma (ALCL) in 2011. At the time of those findings, reported cases…
Zimmer Biomet has issued a Class I recall for its Comprehensive Reverse Shoulder as the devices have exhibited higher rates of fracturing than previously stated. In December 2016, Zimmer Biomet issued an Urgent Medical Device Recall Notice to customers who may have undergone surgery in which a Comprehensive Reverse Shoulder was implanted. This recall has been classified as a Class…
On February 2, 2017, the Food and Drug Administration (FDA) issued a warning regarding reports of rare but serious allergic reactions on the skin of individuals who have used over-the-counter (OTC) products containing chlorhexidine gluconate. The FDA has requested that manufacturers, which produce antiseptic containing the ingredient, issue a warning detailing the risk on the Drug Facts labels of such…
On June 1, 2015, Teleflex Medical notified consumers of an Urgent Medical Device Recall relating to its endobronchial tube, as well as corresponding parts and accessories. According to the recall notification, tubes and parts manufactured and distributed between October 2013 and May 2015 may be defective. The recall comes after the company received consumer complaints alleging that the double swivel…