The FDA has approved a transmucosal tablet formulation of fentanyl citrate (Fentora - Cephalon) for management of breakthrough pain in opioid-tolerant patients with cancer. An oral transmucosal fentanyl lozenge on a stick (Actiq, and others) is also available for this indication, and is widely used off-label for chronic, non-cancer pain as well.

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

Concerns have surfaced again at the FDA and in the media about the safety of acetaminophen and the multiplicity of products on the market in the US that contain various amounts of it.

The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Dalbavancin (Dalvance – Durata) is a long-acting intravenous (IV) lipoglycopeptide antibiotic similar to telavancin (Vibativ). Tedizolid phosphate (Sivextro – Cubist) is an IV and oral oxazolidinone antibacterial drug similar to linezolid (Zyvox). A third IV antibiotic, oritavancin (Orbactiv), recently approved by the FDA for the same indication, will be reviewed in a future...

Pharmacologic management of opioid withdrawal symptoms can reduce the intensity of drug craving and improve treatment retention in patients with opioid use disorder who will receive maintenance treatment. Withdrawal management without subsequent maintenance treatment is associated with high rates of relapse, overdose death, and HIV and/or hepatitis C virus infection. Several guidelines on management of opioid withdrawal are available. Maintenance treatment of opioid use disorder was reviewed in a previous issue.

The copper T 380A (ParaGard - GynoPharma), a new intrauterine contraceptive device (IUD) soon to be marketed in the USA, will be one of only two IUDs available in this country. Progestasert (Alza), which gradually releases progesterone (Medical Letter, 18:65, 1976), is the other.

Cerebral arterial spasm frequently causes ischemic neurological damage after subarachnoid hemorrhage from a ruptured intracranial aneurysm. Nimodipine (Nimotop - Miles), a 1,4-dihydropyridine calcium-entry blocker, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of such patients; an intravenous preparation is available only for investigational use.

Clozapine (Clozaril - Sandoz), a dibenzodiazepine antipsychotic drug that has been available in Europe for many years, was recently approved for marketing by the US Food and Drug Administration. Because of its toxicity, the labeling for clozapine recommends using the drug only for schizophrenic patients who have not responded adequately to standard antipsychotic drugs or have had intolerable adverse effects.

Bepridil hydrochloride (Vascor - McNeil Pharmaceutical/Wallace Laboratories), a calcium-channel blocking agent chemically unrelated to verapamil (Calan, and others), nifedipine (Procardia, and others), or other drugs in this class, was recently approved by the US Food and Drug Administration for oral treatment of chronic stable angina pectoris. Because of its potential adverse effects, the labeling recommends reserving the drug for patients who fail to respond optimally to or are intolerant of other antianginal agents.

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.