The FDA has approved a higher-dose injectable formulation of the opioid antagonist naloxone (Zimhi – Adamis) for emergency treatment of opioid overdose. A single IM or SC injection of the new formulation delivers 5 mg of naloxone; injectable formulations that deliver 0.4 mg or 2 mg of the drug have been available for years. Naloxone is also available in intranasal formulations for the same indication (see Table 1).

Armodafinil (Nuvigil – Cephalon), the R-enantiomer of the non-amphetamine stimulant modafinil (Provigil – Cephalon; Alertec – Shire in Canada), is being promoted directly to the public for treatment of excessive daytime sleepiness associated with shift work.

The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.

The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.

Alprazolam (Xanax - Upjohn), a triazolobenzodiazepine previously available in the USA for treatment of anxiety (Medical Letter 24:41, 1982), was recently approved by the US Food and Drug Administration (FDA) for treatment of panic disorder, with or without agoraphobia. According to one report, alprazolam was the fifth most widely prescribed drug in the USA last year (American Medical News, March 4, 1991, page 4).

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.

Anxiety disorders (generalized anxiety disorder, panic disorder, social anxiety disorder, and various phobias) are the most common form of psychiatric illness. They can be treated effectively with cognitive behavioral therapy (CBT) and/or pharmacotherapy.

In 2013 the FDA approved one new drug and a new combination of 2 old drugs as adjuncts to lifestyle changes for chronic weight management. Lorcaserin (lor-ca-SER-in; Belviq – Arena/Esai) is a selective serotonin 2C receptor agonist. Qsymia (Vivus) is a fixed-dose combination of the weight-loss drug phentermine and an extended-release (ER) formulation of topiramate. The new products are approved for use in obese patients (body mass index [BMI] of ≥30 kg/m2) and for patients who are overweight (BMI ≥27 kg/m2) and have one weight-related risk factor such as hypertension, dyslipidemia or...

Adults with a body mass index (BMI) between 25 and 29.9 kg/m2 are considered overweight. Those with a BMI ≥30 are considered obese. The initial recommendation for any weight loss effort is to achieve a 5-10% reduction in weight, which has been associated with a reduction in the risk of developing type 2 diabetes, hypertension, and dyslipidemia. Diet, exercise, and behavior modification are the preferred methods for losing weight, but long-term weight maintenance can be difficult. Several drugs and devices are FDA-approved for weight reduction and maintenance of weight...

A reader expressed concern that a statement in our article Naloxone (Narcan) Nasal Spray for Opioid Overdose (Med Lett Drugs Ther 2016; 58:1) might be misleading. We stated that heroin has a half-life of 2-6 minutes, which is correct, but heroin is a prodrug that is rapidly metabolized to 6-acetylmorphine and morphine. The risk of respiratory depression is related to those active metabolites, and it may persist well beyond the clearance of heroin from the blood.