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Weekly News Round Up - December 21, 2011

Expanded Boxed Warnings for Antiarrhythmic Multaq (dronedarone)

Updated Multaq label: Increased risk of death, serious cardiovascular events when used in permanent atrial fibrillation Read More...

The FDA has completed a cardiac safety review of the antiarrhythmic Multaq (dronedarone). In addition to patients with decompensated heart failure, an increased risk of death, stroke and heart failure may occur in patients with permanent atrial fibrillation (AF) who are treated with Mutaq. Multaq doubles the risk of death in both patient populations, and doubles the risk of stroke and heart failure hospitalization in patients with permanent AF. AF data was gathered from the PALLAS trial, which was terminated early due to a significantly higher rate of cardiac events and death in the Multaq group compared to placebo. FDA reviewed the ATHENA trial, the trial supporting the current Multaq approval for non-permanent AF, and believes Multaq still provides a benefit for these patients. Multiple warning updates have been posted to the Multaq package insert. Health care providers should review the revised label prior to prescribing Multaq.

FDA Update: SSRI’s and Newborn Pulmonary Hypertension

FDA advises health care providers not to alter current clinical practice of depression treatment during pregnancy Read More...

The FDA is updating selective serotonin reuptake inhibitor (SSRI) antidepressant labels with new information about the risk of Persistent Pulmonary Hypertension of the Newborn (PPHN). PPHN is a rare heart and lung condition previously linked with SSRI treatment during pregnancy. Newborns with PPHN are unable to adapt to breathing outside the womb, which may result in multiple organ damage or death. The original FDA Public Health Advisory from July 2006 was based on a single published study. Since then, conflicting data from additional studies have made it unclear if SSRI use during pregnancy can increase the risk of PPHN.

Simvastatin Dose Update When Coadministered with Amiodarone

Simvastatin package label updated to reflect maximum 20 mg dose when given to patients taking amiodarone Read More...

The FDA has posted a Drug Safety Communication stating that simvastatin doses (including all generics, Zocor, and Vytorin) should not exceed 20 mg/day when taken with the cardiac drug amiodarone (Cordarone). Previously, the maximum recommended dose of simvastatin was 10 mg/day in patients also taking amiodarone. In June of 2011, FDA lowered the maximum 80 mg/day simvastatin dose to 40 mg/day to reduce the risk of myopathy (muscle injury). At that time, the FDA also halved the maximum safe simvastatin dose when combined with certain interacting drugs that can raise blood levels of simvastatin, such as amiodarone. Because no data currently exists to support the simvastatin dose reduction, the FDA is restoring the maximum simvastatin dose to 20 mg/day in patients also taking amiodarone.

Combination Agent Edarbyclor Approved for Hypertension

Once-a-day, fixed-dose, combination azilsartan medoxomil and chlorthalidone approved for hypertension Read More...

The U.S. Food and Drug Administration (FDA) has approved Edarbyclor (azilsartan medoxomil-chlorthalidone), the first fixed-dose angiotensin II receptor blocker (ARB) and chlorthalidone combination for the treatment of hypertension in adults. Both azilsartan medoxomil (Edarbi) and chlorthalidone are available as separate agents for lowering blood pressure. In five clinical trials ranging from 8 to 52 weeks, Edarbyclor lowered mean systolic blood pressure more than either azilsartan medoxomil or chlorthalidone monotherapy, and more than the highest approved dose of hydrochlorothiazide-olmesartan (Benicar HCT). Edarbyclor similarly lowered blood pressure across all ethnic groups. The most common side effects were dizziness and fatigue.

Gilenya (fingolimod): FDA Safety Review of Reported First Dose Death

FDA evaluating case report of MS patient who died within 24 hours after first dose of Gilenya Read More...

Gilenya (fingolimod), an oral medication approved for use in relapsing forms of multiple sclerosis, may lead to a slowed heart rate. According to package labeling, all patients should be observed for bradycardia for six hours after the first dose. The U.S. Food and Drug Administration (FDA) is evaluating a report of death in a patient who died within 24 hours of the first dose Gilenya. The patient had completed the 6 hour observation period without incident. The patient was also receiving treatment with metoprolol and amlodipine. The exact cause of death has not been established. At this time, the FDA believes the benefits of Gilenya outweigh any risks when the drug is used according to package labeling.