The FDA has warned that eluxadoline (Viberzi – Allergan), a mu-opioid receptor agonist and delta-opioid receptor antagonist approved in 2015 for treatment of irritable bowel syndrome with diarrhea (IBS-D),1 should not be used in patients without a gallbladder because of an increased risk of serious pancreatitis.2As of February 2017, the FDA had received reports of 118 cases of serious, nonfatal pancreatitis and 2 deaths associated with use of eluxadoline. Both deaths occurred in patients without a gallbladder who developed severe abdominal pain and vomiting shortly after taking the first...

The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since 2015 for emergency treatment of opioid overdose. Generic formulations of Narcan have also been approved; the manufacturers of these products will be required to switch them to OTC status and amend their labeling accordingly. Kloxxado, an 8-mg naloxone nasal spray, remains available only by prescription.

A fixed-dose combination of oxycodone 5 mg and ibuprofen 400 mg (Combunox - Forest Laboratories) is now available and is being heavily advertised for short-term treatment of moderate to severe acute pain.

The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults with treatment-resistant depression (TRD). This is the first FDA approval for esketamine, which is the S-enantiomer of the intravenous anesthetic ketamine (Ketalar, and generics). In recent years, IV ketamine has been increasingly used (off-label) for treatment of TRD.

On January 10, 2013, the FDA issued a news release to announce that it was requiring the manufacturers of the zolpidem-containing products Ambien, Ambien CR, Edluar and Zolpimist, which are all approved for treatment of insomnia, to lower the doses for women and to recommend in their labeling consideration of a lower dose for men. No change will be required in the dose of Intermezzo, a low-dose sublingual formulation of zolpidem for middle-of-the-night awakening, which is already recommended in a lower dose for women.

The FDA has approved a subcutaneously injected, extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Brixadi – Braeburn) for once-weekly or once-monthly treatment of moderate to severe opioid use disorder. Brixadi is the second subcutaneously injected buprenorphine formulation to be approved in the US; Sublocade, which is administered once monthly, was the first. Buprenorphine is also available for treatment of opioid use disorder in sublingual formulations with and without the opioid antagonist...

On February 9, 2005, Health Canada suspended the marketing of Adderall XR (Shire), a mixture of amphetamine salts used to treat attention-deficit hyperactivity disorder (ADHD) (Med Lett Drugs Ther 1994; 36:109). The immediate-release form of Adderall was never marketed in Canada. The withdrawal was based on 20 reports internationally of sudden death in patients taking the drug. These deaths, 14 of them in children, were not linked to overdose or abuse. The FDA decided that the number of sudden deaths was no greater than expected among the large number of people taking the drug, but because 5...

Esketamine (Spravato – Janssen), an intranasal N-methyl-D-aspartate (NMDA) receptor antagonist that was previously approved by the FDA for treatmentresistant depression,1 has now been approved for treatment of depressive symptoms in adults with major depressive disorder (MDD) and acute suicidal ideation or behavior. Esketamine is the S-enantiomer of the anesthetic ketamine (Ketalar, and generics). It is the first drug to be approved for this indication. Most clinical trials of antidepressants have excluded patients with acute suicidal ideation.

Percutaneous transluminal coronary angioplasty (PTCA), in which a balloon catheter distends the vessel at the site of obstruction (Medical Letter, 25:97, 1983), is now an established therapeutic option for treatment of patients with coronary artery disease, especially those with single-vessel disease. Major problems related to PTCA include acute occlusion during the procedure (usually caused by dissection), restenosis at the site of angioplasty, and inability to treat complete occlusions and long or ostial lesions. Some cardiologists have tried using lasers during PTCA to deal with these...

Clobazam (Onfi – Lundbeck), an oral benzodiazepine, has been approved by the FDA for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥2 years old. It has been available in Canada (Frisium) and other countries for years for treatment of anxiety and many types of epilepsy.