Two FDA advisory committees recently concluded that use of a nasal spray formulation of the peptide hormone salmon calcitonin for treatment of postmenopausal osteoporosis is associated with an increased risk of cancer. Salmon calcitonin is available as 2 nasal sprays (Miacalcin, Fortical) and an injectable formulation (Miacalcin Injection) for use in osteoporosis.1The new cancer concern arose from the results of an unpublished meta-analysis that included 18 studies of Miacalcin Nasal Spray in which the risk of any cancer was 1.54 times greater (95% CI: 1.06, 2.23) in patients who used the drug...

The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2...

The choice of drugs for treatment of pneumonia depends on the most likely pathogens causing the infection and local antimicrobial resistance patterns. Factors such as severity of illness, presence of co-morbid conditions and whether the infection is community or hospital-acquired also need to be considered.

The FDA recently warned that accidental ingestion of the antitussive benzonatate (Tessalon Perles, and others) by children less than 10 years old can be fatal.1 This widely prescribed oral agent, which has been available in the US since 1958, can also cause severe morbidity and death in older children and adults, and not only in overdosage.Benzonatate is a polyglycol derivative structurally related to procaine and tetracaine. It acts peripherally on stretch receptors in the lower respiratory tract to suppress the cough reflex. If the patient chews or sucks the liquid-filled capsules or...

- Merck; Zestril - Stuart), a new angiotensin-converting enzyme (ACE) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for once-daily treatment of . Two other ACE inhibitors, captopril (Capoten - Squibb) and e

Recombinate (Baxter) and Kogenate (Miles), two recombinant-DNA-derived Factor VIII (rFVIII) preparations, were recently approved for marketing by the US Food and Drug Administration. Clotting factor concentrates are generally prepared from large plasma pools obtained from thousands of donors. Without adequate inactivation of viruses, these concentrates can transmit hepatitis B, hepatitis C, and the human immunodeficiency virus (HIV), among others. The new recombinant products, which include human albumin added as a stabilizer, are claimed to be free of blood-borne viruses.

Etravirine (Intelence - Tibotec), a new non-nucleoside reverse transcriptase inhibitor (NNRTI), has received fast-track FDA approval for use in combination therapy in treatment-experienced adults who have HIV-1 infection resistant to an NNRTI and other antiretroviral agents.

The FDA has approved an intravenous (IV) formulation of acetaminophen (Ofirmev – Cadence) for use in patients ≥2 years old for management of pain either as monotherapy (mild to moderate pain) or with an opioid (moderate to severe pain) and for reduction of fever.

The FDA has approved tavaborole 5% solution (Kerydin – Anacor Pharmaceuticals) for topical treatment of toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. It is the first oxaborole antifungal drug to be approved for this indication.

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.