The FDA has approved a new combination, once-daily inhaler for the treatment of chronic obstructive pulmonary disease (COPD). The new agent combines two long-acting agents, the anticholinergic umeclidinium and the beta-agonist vilanterol. The safety and efficacy were evaluated in more than 2400 patients with COPD in which treated patients showed improved lung function compared to placebo. Like other drugs containing long-acting beta-agonists, the drug carries a boxed warning regarding the increased risk of asthma-related death. The drug is not approved for asthma. Umeclidinium and vilanterol inhalation powder will be marketed by GlaxoSmithKline as Anoro Ellipta.
The FDA has approved the first generic version of duloxetine (Cymbalta). The drug is approved for depression, neuropathic pain, generalized anxiety disorder, and fibromyalgia. Multiple generic manufacturers have been approved to market duloxetine.
The FDA has issued a warning regarding the attention deficit hyperactivity disorder (ADHD) drug methylphenidate and priapism (painful and prolonged erections). Methylphenidate is the active ingredient in many commonly used ADHD medications, including Ritalin, Concerta, Daytrana, Focalin, and Metadate. Although rare, priapism can lead to permanent penile damage, so patients should be warned about this potential side effect. Another ADHD drug atomoxetine (Strattera) has also been associated with priapism, perhaps at an even higher rate, but reports are limited so far.
The FDA is concerned about the safety of consumer antibacterial soaps that contain the ingredients triclosan (liquid soaps) and triclocarban (bar soaps). There is currently no evidence that these agents are any more effective than washing with plain soap and water and there is concern that they may pose a health risk such as bacterial resistance or even hormonal effects. They FDA is requiring the manufacturers of these products to demonstrate long-term safety and efficacy if they are to remain on the market. Both triclosan and triclocarban are found in a wide variety of consumer soaps, including Dial liquid and bar soap, Clearasil, and many generic house brand soaps such as CVS antibacterial soap.