The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The potassium-competitive acid blocker vonoprazan (Voquezna – Phathom), which was approved earlier for treatment of erosive esophagitis, has now been approved by the FDA for relief of heartburn associated with nonerosive gastroesophageal reflux disease (GERD) in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection.

Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

Granisetron, a serotonin (5-HT) antagonist similar to ondansetron, was recently approved by the US Food and Drug Administration for prevention of nausea and vomiting due to cancer chemotherapy. Although available in an oral formulation in other countries, granisetron is available here only for intravenous (IV) use.

One of our readers has suggested that more attention should have been paid to a study comparing the antiplatelet effects of immediate-release and enteric-coated aspirin that appeared in Circulation last year.1 The safety benefits of enteric-coated aspirin are unclear. It may protect against dyspepsia, but not against major gastrointestinal bleeding, which is thought to be mainly a systemic effect of prostaglandin inhibition.ANTIPLATELET EFFECTS OF ASPIRIN — Aspirin irreversibly acetylates cyclooxygenase-1, blocking thromboxane synthesis and inhibiting platelet activation and aggregation for...

Betaxolol (Kerlone - Searle), an oral beta-adrenergic blocker, was recently approved by the US Food and Drug Administration for once-daily treatment of hypertension. The new drug is beta 1 (cardio)-selective with no intrinsic sympathomimetic (partial agonist) activity. It is also available in a topical formulation for treatment of glaucoma (Betoptic - Medical Letter, 28:45, 1986). Beta-blockers currently available in the USA for treatment of hypertension are listed in the table below.

The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate response to anticholinergic therapy. Botox is also approved by the FDA for use in detrusor overactivity associated with a neurologic condition such as multiple sclerosis or spinal cord injury, and for chronic migraine, upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm, strabismus, and cosmetic reduction of wrinkles.

The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

A randomized, placebo-controlled trial evaluating the addition of the direct renin inhibitor aliskiren (Tekturna – Novartis) to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in 8606 patients with type 2 diabetes and renal impairment (ALTITUDE) was terminated prematurely by the manufacturer because the combined incidence of cardiovascular and renal events was higher in patients who received aliskiren than in those who received placebo.1Combining two different types of drugs that block the renin angiotensin system in patients at high-risk for...

The FDA has approved two new drugs for treatment of specific subtypes of acute myeloid leukemia (AML).Vyxeos (Jazz Pharmaceuticals) is a liposomal fixed-dose combination of daunorubicin and cytarabine, the standard drugs used for induction treatment of AML. It is approved for induction and consolidation treatment in adults with newly diagnosed chemotherapy- or radiation-related AML or AML with myelodysplasia-related changes. Patients with these subtypes of AML have a poor prognosis. The rationale for development of the combination was that nano-scale liposomal drug delivery vehicles prolong...