Food and Drug Adminstration (FDA): Patient Safety News

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

10/31/2008 11:00 PM
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 ...

Recalls and Safety Alerts: Serious Injection Site Reactions with Vivitrol

10/31/2008 11:00 PM
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 ...

Recalls and Safety Alerts: Updated Warning on Byetta

10/31/2008 11:00 PM
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...

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

10/31/2008 11:00 PM
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...

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

10/31/2008 11:00 PM
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...

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

10/31/2008 11:00 PM
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...

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

10/31/2008 11:00 PM
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...

Preventing Medical Errors: Tragic Events with Concentrated Opiate Oral Solutions

10/31/2008 11:00 PM
An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions. ISMP cites a recent case involving an 18 year old who was prescribed oxycodone oral solution to ...

New from FDA: FDA?s Drug Safety Newsletter Now Available

10/31/2008 11:00 PM
Every year, FDA receives more than 400,000 reports of adverse events associated with the use of drugs marketed in the U.S. FDA continually reviews these reports to identify signals of potential drug risks. The Drug Safety Newsletter is one way ...

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