FDA Actions
March 1, 2014
The FDA is advising clinicians to stop prescribing combination drugs containing more than 325 mg of acetaminophen as part of the policy to reduce liver injury from accidental overdose. The agency banned combination products with more than 325 mg of acetaminophen starting this year, but many drug combinations, including many commonly used pain medications (hydrocodone/acetaminophen and others), remain on the market for now. Over the last 10 years, the agency has seen increased liver injury and death from patients who took more than the prescribed dose of acetaminophen-containing products in 24 hours or took more than one combination product the same time. Alcohol also raises the risk of acetaminophen injury.
The FDA is proposing a study to assess safety outcomes in patients with atrial fibrillation treated with dabigatran (Pradaxa). The agency is asking for public input on the design of the study with particular focus on the risk of ischemic stroke, intracranial hemorrhage, and major extracranial hemorrhage compared to patients treated with warfarin. The study will utilize the FDA’s Mini-Sentinel Distributed Database of multiple sources of adverse reactions with dabigatran and warfarin. The FDA stresses that this study does not indicate safety issues with the drug. However, similar studies have not been done with the two other novel oral anticoagulants, rivaroxaban and apixaban.
The FDA has approved dapagliflozin for the treatment of type 2 diabetes in adults. The drug is a sodium-glucose cotransporter 2 inhibitor that blocks the reabsorption of glucose by the kidney. It is the second drug in this class after canagliflozin (Invokana), which was approved 1 year ago. It is approved as monotherapy or in combination with other type 2 diabetes drugs. Dapagliflozin is not for use in type 1 diabetes or in patients with renal disease or a history of ketoacidosis. An increased number of bladder cancers were diagnosed among users of the drug in clinical trials. The drug can also cause dehydration and hypotension in susceptible patients, including the elderly and those on diuretics. The FDA is requiring postmarketing studies on the risk for cardiovascular disease and bladder cancer. Dapagliflozin in marketed by Bristol-Myers Squibb as Farxiga.
The FDA has approved the first treatment for non-24-hour sleep-wake disorder (“non-24”) in totally blind individuals. Tasimelteon is a melatonin receptor agonist that helps regulate disrupted sleep/awake cycles in those individuals who can’t perceive light well enough to establish a normal night sleep schedule. In clinical trials of 104 participants, tasimelteon resulted in significant improvement in non-24 disorder. The drug should be taken at the same time every night. Side effects may include impaired mental alertness, headache, elevated LFTs, nightmares, disturbed sleep, upper respiratory infections, or urinary tract infections. The drug was approved under the FDA’s priority review process. Tasimelteon is marketed by Vanda Pharmaceuticals as Hetlioz.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content