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.

The FDA has approved Prestalia (Symplmed), an oral fixed-dose combination of the dihydropyridine calcium channel blocker amlodipine (Norvasc, and generics) and a new salt form of the angiotensin-converting enzyme (ACE) inhibitor perindopril, for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and in those just starting therapy who are likely to need multiple drugs to control their blood pressure. The new salt form (perindopril arginine) is more stable and has a longer shelf-life than perindopril erbumine (Aceon, and...

The FDA has approved anthrax vaccine adsorbed (AVA; BioThrax – Emergent BioSolutions) for prevention of anthrax disease in adults following exposure to Bacillus anthracis and intravenous anthrax immune globulin (Anthrasil – Emergent BioSolutions) for treatment of inhalation anthrax in adults and children. AVA has been available since 1970 for prevention of anthrax disease in persons at high risk of exposure.

The FDA has approved a 10% nanoemulsion gel formulation of the porphyrin-based photosensitizer aminolevulinic acid hydrochloride (ALA; Ameluz – Biofrontera) for use in combination with a narrowband red light photodynamic therapy (PDT) lamp (BF-RhodoLED) for treatment of actinic keratoses (AKs) of mild to moderate severity on the face and scalp. A 20% ALA solution (Levulan Kerastick) approved for use in combination with blue light PDT (BLU-U) has been available in the US since 2002.

The FDA has approved an extended-release orally disintegrating tablet formulation of methylphenidate (Cotempla XR-ODT – Neos Therapeutics) for once-daily treatment of attention-defi cit/hyperactivity disorder (ADHD) in children 6-17 years old. Cotempla XR-ODT is the first extended-release orally disintegrating tablet formulation of methylphenidate to become available in the US.

Lisdexamfetamine dimesylate (Vyvanse - Shire), a prodrug in which d-amphetamine is covalently bonded to L-lysine, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years old. It was designed to have less potential than amphetamine itself for abuse, diversion or overdose toxicity. Like methylphenidate and amphetamines, lisdexamfetamine is a Schedule II controlled substance.

Ambrisentan (Letairis - Gilead), a selective endothelin type A (ET_A) receptor antagonist, has been approved by the FDA for treatment of symptomatic patients (WHO class II or III) with pulmonary arterial hypertension (PAH).

Harvesting of autogenous bone, most commonly from the iliac crest, for use as the interbody graft in spinal fusion procedures has been standard practice, but is associated with a high rate of morbidity, including graft site pain, infection, fracture, bleeding and damage to the femoral nerve. Use of recombinant human bone morphogenetic protein (rhBMP-2; Infuse Bone Graft - Medtronic) was first approved by the FDA in 2002 for single-level anterior lumbar spinal fusion in adults with degenerative disc disease who had not responded to at least 6 months of nonoperative treatment. Now it has also...

The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

Becaplermin (be kap' ler min; Regranex - Ortho-McNeil), a 0.01% topical gel formulation of recombinant human platelet-derived growth factor (rhPDGF), was recently approved by the FDA for adjunctive treatment of diabetic ulcers of the lower extremities that extend subcutaneously or beyond and have an adequate blood supply. Endogenous platelet-derived growth factor increases proliferation of cells that repair wounds and form granulation tissue.