Scalpel Weekly News

Week of: December 17, 2013

IN THE NEWS


Serious Skin Reactions from Anti-seizure Drug

The FDA warned the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. The FDA approved changes to the Onfi drug label to add information about the risk for serious skin reactions to the Warnings and Precautions section and to the Medication Guide. Click title to continue reading...


 
MEDICAL ALERTS


Defective Defibrillators May Fail to Deliver Shock

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. Click title to continue reading... 



New Drug Approved to Treat Chronic Hepatitis C

The FDA approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the second drug recently approved by the FDA to treat chronic HCV infection. Previously, the FDA approved Olysio (simeprevir). Click title to continue reading... 



Measles Continues to Threaten World Health Security

Fifty years after the approval of an extremely effective vaccine against measles, one of the world’s most contagious diseases, the virus still poses a threat to domestic and global health security. On an average day, 430 children – 18 every hour – die of measles worldwide. Click title to continue reading... 


  CASE ALERTS


Labeling Action Against Generic Drug Manufacturers Dismissed

The doctors of certain consumers prescribed Reglan. The doctors relied upon information published in the package inserts for Reglan, the Physicians' Desk Reference, or other information disseminated by the brand name manufacturers of Reglan. Click title to continue reading... 



False Claims Suit Fails; Failure to Plead Fraud with Particularity

A pharmaceutical manufacturer contracted with a physician to perform medical reviews of adverse event reports for four drugs: Actos (type 2 diabetes), Uloric (gout), Kapidex/Dexilant (gastroesophageal reflux disease), and Prevacid (same). Click title to continue reading... 



False Claims Suit Alleges Overbilling for Physician Services; DOJ Intervenes

The government has intervened in a lawsuit against IPC The Hospitalist Co. Inc., and its subsidiaries (IPC), alleging that IPC submitted false claims to federal health care programs. Click title to continue reading...