Nizatidine (Axid - Lilly), a new H2-receptor antagonist similar to cimetidine (Tagamet), ranitidine (Zantac) and famotidine (Pepcid), was recently approved by the US Food and Drug Administration for treatment of active duodenal ulcer and for maintenance therapy after healing. Cimetidine, ranitidine and famotidine are also approved for treatment of pathological hypersecretory conditions such as Zollinger- Ellison syndrome; cimetidine is approved in addition for treatment of gastric ulcers.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

Current guidelines recommend use of a proton pump inhibitor (PPI) to decrease the risk of gastrointestinal bleeding in patients taking clopidogrel (Plavix) with aspirin. A recent issue of The Medical Letter considered whether omeprazole (Prilosec, and others) or other PPIs could interfere with the antiplatelet effect of clopidogrel. The conclusion was that patients taking both drugs should probably continue to do so until more data became available. Several new publications require reconsideration of that recommendation.

Vilazodone (Viibryd – Forest), a selective serotonin reuptake inhibitor (SSRI) and partial 5-HT_1A receptor agonist, has been approved by the FDA for treatment of depression. It has been claimed to have no sexual side effects and not to cause weight gain.

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved Roxybond (Daiichi Sankyo), an short-acting (SA) oxycodone formulation with abuse-deterrent properties, for treatment of pain requiring management with an opioid. Roxybond is the first SA opioid to be approved as an abuse-deterrent product. Oxaydo, another IR oxycodone formulation, has properties that discourage its intranasal and intravenous use, but is not considered an abuse-deterrent product by the FDA. Use of opioids for treatment of pain was reviewed in a recent issue.

Misoprostol (Cytotec, and generics), a prostaglandin E₁ analog FDA-approved for prevention of NSAID-induced gastric ulcers and, when taken with mifepristone (Mifeprex), for termination of early intrauterine pregnancy, has also been used off-label for years for medical management of first-trimester spontaneous abortion (miscarriage).

The antiplatelet drug clopidogrel (Plavix, and others) reduces major cardiovascular events, but can cause bleeding. Proton pump inhibitors (PPIs) are often used with clopidogrel to prevent gastrointestinal bleeding, however, some evidence suggests that PPIs may interfere with the activation of clopidogrel and diminish its antiplatelet effect. FDA-approved labeling recommends avoiding concurrent use of the PPIs omeprazole and esomeprazole with clopidogrel.

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

Rofecoxib (Vioxx - Merck) has been withdrawn from the market due to an increased risk of cardiovascular complications associated with its long-term use. The question remains whether all selective COX-2 inhibitors carry the same risk. Full-page advertisements in newspapers for celecoxib (Celebrex - Pfizer), the most widely used COX-2 inhibitor, assure the public that it does not.