FDA Warns Public of Extortion Scam by FDA Impersonators

November 12, 2008

The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials.

Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls

FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer

November 6, 2008

The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.

Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes (November 5)

November 5, 2008

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Written by Food and Drug Administration Press Releases · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Serious Fungal Infections with Humira, Cimzia, Enbrel and Remicade

October 31, 2008

The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been ...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol

October 31, 2008

FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence. FDA has received nearly ...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Updated Warning on Byetta

October 31, 2008

In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in pat...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Importance of Influenza Vaccination for Health Care Personnel

October 31, 2008

As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and als...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia

October 31, 2008

FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Serious Hypersensitivity Reactions with Abacavir (Ziagen)

October 31, 2008

FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen an...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls

Recalls and Safety Alerts: Serious Muscle Injury with Simvastatin/Amiodarone Combination

October 31, 2008

FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antia...

Written by Food and Drug Adminstration (FDA): Patient Safety News · Filed Under FDA: News/Recalls