The FDA has approved a subdermal buprenorphine implant for maintenance treatment of opioid dependence. The implant provides a constant, low-level dose of buprenorphine for six months. It is approved for those who have already been on a stable dose of buprenorphine as part of a complete treatment program. Prior to approval, buprenorphine for the treatment of opioid dependence was only available as a pill or film. The new implant offers convenience and eliminates the risk of theft or missing a dose, according to the FDA. Buprenorphine, along with methadone and naltrexone, is part of medication-assisted treatment, which is part of the FDA’s opioid action plan and a top priority for the U.S. Department of Health and Human Services’ opioid initiative. Medication-assisted treatment combines medications with counseling and other behavioral therapies to treat patients with opioid use disorder. The safety and efficacy of the buprenorphine implant was demonstrated in a single randomized trial of adults with opioid dependence who were stabilized on oral buprenorphine. Response was measured as urine screening and self-reported illicit drug use. The implant resulted in 63% response compared with 64% for buprenorphine sublingual. The buprenorphine implant is marketed as Probuphine.
The FDA is warning health professionals against using ketoconazole for the treatment of skin and nail fungal infections because of the risk of hepatotoxicity, adrenal toxicity, and drug-drug interactions. The FDA removed skin and nail fungal infections as an indication for use of the drug in 2013, but a safety review found physicians continue prescribing ketoconazole for these conditions. Ketoconazole should be used only to treat serious fungal infections when no other therapies are available ().
The FDA is investigating a possible link between canagliflozin and an increase in leg and foot amputations. Canagliflozin (Invokana, Invokamet) is a SGLT2 inhibitor used to treat type 2 diabetes. These drugs block reabsorption of glucose by the kidney resulting in excretion of glucose in the urine. An ongoing clinical trial (Canagliflozin Cardiovascular Assessment Study [CANVAS]) found an increase in leg and foot amputations, mostly affecting the toes. The new warning is not suggesting a cause and effect between the drug and amputations but is studying the issue further and will update the public when more information is available. After follow up of about 4.5 years, CANVAS found that a rate of amputations per year with canagliflozin was about more than twice that of placebo: 7/1000 with 100 mg daily, 5/1000 with 300 mg daily, compared to 3/1000 with placebo. Until more data are available, the FDA recommends monitoring patients on canagliflozin for leg or foot symptoms ().
The FDA advises against using fluoroquinolones for common infections such as sinusitis, bronchitis, and uncomplicated urinary tract infections. Fluoroquinolones, or “quinolones,” include the popular antibiotics ciprofloxacin, moxifloxacin, and levofloxacin. The FDA’s warning is the result of a safety review that has shown that quinolones are associated with “with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system,” including neuropathy, tendinopathy including tendon rupture, and neuropsychiatric side effects. The FDA says the risks of quinolones generally outweigh the benefits in these common infections and alternatives should be used as first-line treatment ().
The FDA has approved daclizumab for the treatment of relapsing multiple sclerosis. The drug is a monoclonal antibody that binds to the alpha subunit of the IL-2 receptor of T cells. It is self-administered once monthly by injection. The FDA recommends using daclizumab only in patients who have had an inadequate response to two or more multiple sclerosis drugs because of serious safety risks, including liver and immune conditions. Because of the risks, the drug is only available through a restricted distribution program under a Risk Evaluation and Mitigation Strategy. Safety and efficacy were shown in two clinical trials. The first was a head-to-head trial with interferon beta-1a (Avonex); patients on daclizumab experienced fewer clinical relapses. The second study showed the drug was superior to placebo.