Zantac Ordered Off Store Shelves Over Cancer Risks

Blurred pink pills

FDA mandates halt to distribution of ranitidine (Zantac) due to potentially carcinogenic contamination

After previously warning consumers and doctors last September that it had found measurable amounts of the carcinogen NDMA (N-notrisodimethylamine) in samples of the widely-used heartburn medication Zantac, the U.S. Food and Drug Administration has now ordered manufacturers to immediately stop distributing all versions of the drug over new concerns that small amounts of the poison can increase in the drug when it is stored above room temperature. [Read more…]

The FDA Wants Consumers to Report Problems with MedWatch

FDA Invites Consumers to Report Problems to MedWatch

The U.S. Food and Drug Administration (FDA) has enhanced its MedWatch program and is actively asking consumers to report adverse events and serious safety issues with regard to FDA regulated products, whether they be medications, medical devices, or food products. The FDA encourages strongly consumers to use the MedWatch platform, first created in 1993, to report experiences with problematic products that seem to have unexpected side effects, injurious medical errors, therapeutic failures, issues with product quality, and any other safety hazards. [Read more…]

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

The U.S. Food and Drug Administration (FDA) has announced a public hearing forum to take place on November 9-10, 2016 with regard to the enforcement of rules relating to off-label drug and medical product use in the public health industry. The registration deadline to present at the hearing is October 19, 2016, and the deadline for written commentary after the hearing is January 9, 2017. [Read more…]

FDA Classifies Transvaginal Mesh as High-Risk due to Serious Complications from Surgery

FDA Classifies Transvaginal Mesh As High Risk

The U.S. Food and Drug Administration (FDA) has reclassified the surgical mesh device utilized for transvaginal repair of pelvic organ prolapse (“POP”) and other conditions in women as a high-risk (class III) product. Previously, the agency classified the product as moderate-risk (class II). [Read more…]