Byetta Linked to Acute Pancreatitis

Six new cases of hemorrhagic or necrotizing pancreatitis have been reported in patients using exenatide injection (Byetta, Amylin Pharmaceuticals, Inc), the US Food and Drug Administration (FDA) advised healthcare professionals today.

Why Should I Report an Adverse Drug Event?

When I was in charge of the postmarketing drug safety program at the US Food and Drug Administration (FDA) in the early 1980s, 1 particular drug report became etched in my memory.

FDA Warns About Injection Site Reactions With Naltrexone

Injectable, extended-release naltrexone (Vivitrol, Cephalon), used for the treatment of alcohol dependence, has been linked to adverse injection-site reactions, some requiring surgery, according to a US Food and Drug Administration (FDA) advisory notice to healthcare professionals released yesterday.

Levitronix CentriMag Extracorporeal Blood Pumping System

Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers

FDA unexpectedly rejects Schering anesthesia drug

Schering-Plough Corp (nyse: SGP – news – people ) said Friday U.S. regulators had rejected Bridion, its drug to reverse the effects of anesthesia that had been heralded as a breakthrough product by analysts and was unanimously recommended by a federal advisory panel.

FDA Extends Consumer Warning on Serrano Peppers from Mexico

Laboratory testing by the U.S. Food and Drug Administration has confirmed that both a sample of serrano pepper and a sample of irrigation water collected by agency investigators on a farm in the state of Tamaulipas, Mexico (business address is in Nuevo Leon, Mexico) contain Salmonella Saintpaul with the same genetic fingerprint as the strain […]

U.S. Lawmakers Probe FDA Approval of Ranbaxy Drugs

Two leading U.S. Democrats said on Tuesday they are investigating whether Food and Drug Administration knowingly allowed the sale of Ranbaxy drugs that may have been backed by fraudulent data. The congressional investigation stems from information released as part of a probe by U.S. law enforcement authorities into whether the Indian drugmaker submitted false data […]

FDA Approvals: KINRIX and Metvixia

The US Food and Drug Administration (FDA) has approved a combination vaccine that offers protection against diphtheria, tetanus, pertussis, and polio in a single shot; and the use of methyl aminolevulinate 16.8% cream with a narrow-band, red-light device equipped with light-emitting diodes for the treatment of actinic keratoses.

Merck’s Gardasil Not Cleared for Older Women

U.S. regulators have told Merck & Co they cannot yet approve Merck's application to expand marketing of its HPV vaccine Gardasil to an older group of women, the drugmaker said Wednesday.

Heparin Contamination Was Deliberate Act to Cut Costs?

Contamination of the worldwide heparin supply, which resulted in a substantial increase in adverse events and an estimated 81 deaths in the US, appears to have been a deliberate act to increase profits in Chinese workshops.