Dangerous Drugs & Devices Archives

FDA issues safety announcement regarding health risks associated with testosterone products

On January 31, 2014, the U.S. Food and Drug Administration (FDA) issued a safety alert indicating the agency will investigate whether an association exists between the use of FDA-approved testosterone products and the increased risk of stroke, heart attack and death in men.

HPV VACCINE: DOES THE RISK OUTWEIGH THE BENEFIT?

HPV (“human papillomavirus”) is a common virus that can be passed from one person to another during sex.

FDA ANNOUNCES IMPROVEMENTS TO MEDICAL DEVICE RECALL DATABASE

According to an FDA news release posted on December 16, 2013, the U.S. Food and Drug Administration (“FDA”) has made improvements to…

DEPUY ASR SETTLEMENT UPDATE

The Settlement Oversight Committee recently released an overview of the benefits provided by the U.S. ASR Settlement Program: (more…)

DEPUY ASR SETTLEMENT PROGRAM ANNOUNCED

A status conference was held on Tuesday, November 19, 2013, in the consolidated federal multi-district litigation (“MDL”) before Judge David Katz in…

“FDA to Reclassify Hydrocodone to Tighten Prescribing Protocols”

Abuse of Opioids Prompts FDA Scrutiny: The FDA has been evaluating the appropriate use of opioid products very carefully over the past…

FDA UPDATES OPIOID LABEL TO PROMOTE SAFER USE

The Food and Drug Administration (“FDA”) has new labeling requirements for extended-release and long-acting (“ER/LA”) opioid pain relievers to ensure their safe…