The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

Live-attenuated vaccines are generally contraindicated during pregnancy; inactivated vaccines can be given if indicated. A more detailed review of routine immunizations for adults will be available in the December issue of Treatment Guidelines from The Medical Letter.

Electronic cigarettes, also called e-cigarettes, are battery-operated nicotine-delivery devices that resemble tobacco cigarettes. They deliver vapor containing a mixture of nicotine and either propylene glycol or glycerol. E-cigarettes are widely available in retail stores and on the internet in labeled strengths ranging from zero to high levels of nicotine and in flavors such as tobacco, mint, coffee, cherry, bubblegum, and chocolate. They are advertised as a healthier alternative to smoking a tobacco cigarette and, although not FDA-approved, as a smoking cessation tool.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

Omalizumab (Xolair) is a recombinant humanized monoclonal anti-IgE antibody currently approved by the FDA for treatment of moderate to severe persistent allergic asthma. It has been used off-label for treatment of allergic rhinitis and food allergies. Recently the results of a phase III clinical trial indicated that omalizumab may be effective in treating chronic urticaria as well.

Most patients with end-stage renal disease develop hyperphosphatemia, which can lead to secondary hyperparathyroidism, vascular calcification, and cardiovascular mortality. The FDA has approved sucroferric oxyhydroxide (Velphoro – Fresenius Medical Care), a chewable phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the first iron-based phosphate binder to be approved for this indication.

An article published in the New York Times on May 1, 2015 listed the 10 drugs on which Medicare Part D spent the most in 2013. The most costly ($2.53 billion) was the proton pump inhibitor (PPI) Nexium (esomeprazole magnesium), which has recently become available generically.

The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.