• Maryland: In a class-wide labeling update, FDA removed a boxed warning for major adverse cardiovascular events on all testosterone products. The decision to remove the warning was based on findings from the Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial. FDA also reviewed postmarket ambulatory blood pressure studies, which found a class-wide increase in blood pressure with testosterone. As a result, FDA plans to require product-specific information about increased blood pressure to be added to the labels of certain testosterone products, along with new warnings for products that don't already have them. This "action follows several prior FDA actions regarding the safety of testosterone products, including a January 2014 Drug Safety Communication (DSC) warning of reported risks of stroke, heart attack, and death in men taking FDA-approved testosterone products; and a March 2015 DSC informing of required labeling changes and urging caution when using testosterone products for low testosterone due to aging," the agency said in a statement. (Monaco, MedPage Today, 3/3)
• New Jersey: Johnson & Johnson MedTech has recalled its Biosense Webster Varipulse Bi-Directional Ablation Catheter after receiving reports of patients experiencing strokes and transient ischemic attacks while undergoing procedures with the device. During an evaluation, four out of 132 (3%) patients experienced strokes or transient ischemic attacks, higher than the 1% rate expected for similar procedures. The recall, which is categorized as the most serious type by FDA, does not remove the product from the market. Instead, it updates the product's use instructions to emphasize adherence to recommended use parameters to reduce the risk of strokes. Healthcare providers should review the new instructions, assess potential risks with new patients, and continue to monitor patients who have undergone procedures with the device. (Murphy, Becker's Hospital Review, 3/3)
• Wyoming: Last month, Gov. Mark Gordon (R) signed a bill requiring clinics that provide procedural abortions to be licensed as ambulatory surgical centers. Currently, there is only one clinic in Wyoming that provides abortions, Wellspring Health Access. Under the bill, physicians at the clinic will have to get admitting privileges at a hospital no more than 10 miles away, and the clinic must renovate doorways and halls. According to Wyoming Public Radio, the bill will likely lead to Wellspring's closure. Julie Burkhart, founder and president of Wellspring, said the clinic plans to sue to stop the new law. "We will be filing a lawsuit seeking a restraining order to stop this unjust law from being enacted," Burkhart said. "And know this: We are here, and we are not backing down." Wellspring also has an ongoing court case regarding two near-total abortion bans in the state. These bans were struck down by a district judge last year and will be presented before the state Supreme Court in the spring. (Clements, Wyoming Public Radio, 2/27)

According to a  study published in the New England Journal of Medicine (NJEM), testosterone replacement therapy was not associated with an increased risk of major cardiac events, such as heart attacks or strokes. However, health experts caution that these findings should not be used "as a justification for a more widespread use of testosterone in men," particularly those who are looking to feel younger or build muscle mass.