FDA MedWatch

Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers.

Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.

Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year.

Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.

UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta.

Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.

Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.

Serious injection site reactions may occur with the use of injectable naltrexone.

UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.

Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily.