DECEMBER 2011: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

DECEMBER 2011: Pregnant women using selective serotonin reuptake inhibitor (SSRI) antidepressants may have the potential risk of rare heart and lung condition known as Persistent Pulmonary Hypertension of the Newborn (PPHN).

DECEMBER 2011: Zocor (simvastatin)80 mg label has been changed as along with new restrictions and dose limitations. Dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction. The reason for these changes is because high doses can increase the risk of muscle damage. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.

DECEMBER 2011: Multaq (dronedarone)increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF).

DECEMBER 2011: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.

DECEMBER 2011: Eclectic Institute Is recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) capsules because of potential Salmonella contamination. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, elderly people, and others with weakened immune systems. Side effects include fever, diarrhea, nausea, vomiting and abdominal pain.

DECEMBER 2011: Liquid Acetaminophen for infants (160 mg/5 mL) is now available. This change in the concentration will affect the amount of liquid given to an infant for drug safety purposes.