Department: Medication Update
Dabigatran bleeding events spur FDA review
The FDA is evaluating postmarketing reports of serious bleeding events in patients taking dabigatran etexilate mesylate (Pradaxa), manufactured by Boehringer Ingelheim. Pradaxa's product labeling contains a warning about significant and sometimes fatal bleeding.
A clinical trial involving 18,000 patients that compared Pradaxa and warfarin found that major bleeding events occurred at similar rates with the two drugs. The agency is working to determine if the reports of bleeding in patients taking Pradaxa occur more frequently than would be expected based on observations in the trial that supported approval of Pradaxa.
The FDA continues to support Pradaxa as providing an important health benefit when used as directed. The agency will communicate with healthcare providers and the public when new information becomes available.
Death leads to fingolimod investigation
The FDA has received a report of a death within 24 hours of taking the first dose of fingolimod (Gilenya), used to treat multiple sclerosis (MS). The agency is not yet able to conclude whether the medication had a role in the patient's death and is continuing to evaluate the case.
The agency continues to believe that when used according to product labeling, Gilenya provides an important health benefit. Any new findings from the investigation will be communicated when they are available. The FDA encourages healthcare professionals and patients to report adverse events or adverse reactions related to the use of this product to the agency's Medwatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm or by fax to 1–800-FDA-0178.
Gilenya is a product of Novartis.
Ischemic event warning added to dronedarone
A safety review of dronedarone (Multaq) shows that the medication increased the risk of serious cardiovascular events, including death, when used by patients with permanent atrial fibrillation (AF). As a result, the FDA is requiring that the drug's labeling be changed to include the following warnings:
- Dronedarone should not be prescribed for patients with permanent AF because of the twofold risk of cardiovascular death, stroke, and heart failure in these patients.
- Patients taking dronedarone should be monitored via ECG every 3 months, and if AF is detected, patients should discontinue the drug or undergo cardioversion.
- Patients taking dronedarone should receive appropriate antithrombotic therapy.
The FDA is reviewing the Risk Evaluation and Mitigation Strategy to determine the necessary changes.
The FDA's review was based on data from the Pallas and Athena clinical trials. Dronedarone is a product of Sanofi-Aventis.
FDA approves new hypertension treatment
Takeda's azilsartan medoxomil and chlorthalidone (Edarbyclor) combination oral treatment has received FDA approval for treatment of hypertension in adults. It is the only fixed-dose antihypertension therapy to combine an angiotensin II receptor blocker with the diuretic chlorthalidone in a once-daily, single tablet.
In clinical trials, Edarbyclor showed statistically significant reductions in systolic BP compared with its respective monotherapies, and was shown to be superior to the fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide at maximum respective doses. The studies showed that Edarbyclor lowered BP in Black and non-Black patients at similar levels.
Edarbyclor's recommended once daily starting dose is 40/12.5 mg; the maximum dose is 40/25 mg.
The most common adverse reactions seen in clinical studies were dizziness and fatigue. Edarbyclor is contraindicated in patients with anuria and in pregnant women. It is a pregnancy category D drug. For further prescribing information, consult the product labeling.