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Preventing Medical Errors: MedWatch: Reporting Adverse Events

FDA's Medwatch program allows health care professionals and consumers to report to the FDA serious problems with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify importan...

Preventing Medical Errors: Preventing Burns from Electric Dental Handpieces

FDA is warning dental professionals about serious patient injuries caused by poorly maintained electric dental handpieces. Some patients have experienced third degree burns that needed plastic surgery. The burns have occurred during tooth extractio...

Recalls and Safety Alerts: Alaris (Medley) Infusion Pumps Recalled

Cardinal Health is recalling all Alaris Infusion Pump modules shipped before September 27, 2007. The products, which are Model 8100, were formerly known as Medley Pump modules. The company recalled these units after receiving reports of inaccurat...

Recalls and Safety Alerts: Potentially Fatal Hyponatremia from Desmopressin

FDA is notifying healthcare professionals about the risk of potentially fatal hyponatremia in certain patients treated with desmopressin, an antidiuretic that is sometimes used to treat nocturnal enuresis (bedwetting). It works by reducing water los...

Recalls and Safety Alerts: Dangerous Skin Reactions from Carbamazepine

FDA is alerting healthcare professionals about dangerous and possibly fatal skin reactions to the drug carbamazepine in certain patient populations. The reactions have included Stevens Johnson syndrome and toxic epidermal necrolysis. Carbamazep...

Recalls and Safety Alerts: Warning on Exjade and Liver Failure

Novartis is warning healthcare professionals that hepatic failure can occur in patients treated with Exjade(deferasirox). Exjade is used to treat tranfusional hemosiderosis, the chronic iron overload that can result from multiple blood transfusions....

Recalls and Safety Alerts: Severe Pain with Osteoporosis Drugs

FDA is alerting healthcare professionals that severe bone, joint, or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel (risedronate sodium), Reclast (zoledronic acid) and Boniva (ibandronate s...

Recalls and Safety Alerts: Recall of Heparin and Saline Flush Syringes

Here is an alert about a nationwide recall of all heparin and normal saline flushes manufactured by AM2 PAT, Inc. These pre-filled syringes are distributed under two brand names: Sierra Pre-filled and B. Braun. Some of the syringes have been fou...

New Medical Products: First Drug to Treat PKU Approved

FDA has approved the first drug to treat phenylketonuria, or PKU, which is a genetic disorder that affects one in about 15 thousand births in the U.S. The drug, called Kuvan was developed by BioMarin Pharmaceutical in partnership with Merck. Tho...

No Benefit to Rheumatoid Arthritis Found with Hormone Replacement Therapy

WASHINGTON -- Postmenopausal hormone therapy neither reduces the risk of rheumatoid arthritis nor eases the severity of the condition's symptoms, researchers here reported.

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