A fixed-dose combination of two antihyperglycemic drugs, glyburide and metformin, has been approved by the US FDA for initial treatment of type 2 diabetes or when glucose control is unsatisfactory with either drug alone

Ponatinib (Iclusig – Ariad), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome- positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to prior tyrosine kinase inhibitor therapy. It is the fifth tyrosine kinase inhibitor approved for the treatment of CML or Ph+ ALL.

The FDA has approved abaloparatide (Tymlos – Radius Health), a synthetic analog of human parathyroid hormone related peptide, for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. Abaloparatide is the second parathyroid hormone receptor agonist to be approved for this indication; teriparatide (Forteo – Lilly), a recombinant parathyroid hormone analog, was the first. They are the only drugs approved for treatment of osteoporosis that stimulate bone formation. Other drugs used for this indication inhibit bone resorption.

Mirvetuximab soravtansine-gynx (Elahere – Immuno-Gen), an antibody-drug conjugate, has received accelerated approval by the FDA for treatment of folate receptor (FR) alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy. Accelerated approval was based on the overall response rate and median duration of response.

The FDA has approved iDose TR (Glaukos), an intracameral implant containing the prostaglandin analog (PGA) travoprost, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Travoprost is also available as a topical ophthalmic solution (Travatan Z, and generics) for the same indication. iDose TR is the second ocular implant to become available in the US for this indication; Durysta, an intracameral implant containing the prostaglandin analog bimatoprost, was the first.

New guidelines from The National Cholesterol Education Program recommend, as a therapeutic option, lowering treatment goals for LDL cholesterol (LDL-C) from <100 mg/dL to <70 mg/dL for patients at very high risk for coronary heart disease and from 130 mg/dL to <100 mg/dL for those at moderately high risk. A likely consequence of these recommendations is increased use of statins and use of higher doses with a concomitant increase in adverse effects.

The antiplatelet agents aspirin and clopidogrel (Plavix, and others) are used in most patients undergoing percutaneous coronary intervention (PCI) to prevent stent thrombosis and to reduce the occurrence of peri-, post-procedural and late cardiovascular events. Despite a large number of randomized trials of these agents in such patients, the optimal dosage and duration of treatment with these drugs, and whether other drugs should be added, is unclear.

Many prescriptions for eye drops call for instillation of 1-2 drops. But Medical Letter consultants in ophthalmology seem to agree that all eye drops should generally be given in doses of only one drop. The volume of a single drop can vary with the viscosity of the solution, the design of the dropper, and patient technique. The average volume of a drop is 35-50 microliters, but can be as high as 75 microliters. An eye brimming with fluid holds 30 microliters at best, so even one drop is often an overdose. A second either washes out the first or increases the possibility of systemic toxicity,...

The FDA has approved icatibant (Firazyr – Shire), a selective bradykinin B2 receptor antagonist, for treatment of acute attacks of hereditary angioedema (HAE). HAE is a rare autosomal dominant disorder (estimated prevalence 1:10,000-50,000) in which patients experience recurrent and frequently unpredictable attacks of angioedema lasting 2-5 days, typically involving the extremities, gastrointestinal tract, genitalia, face, oropharynx or larynx. Laryngeal edema may be life-threatening. HAE is usually caused by a mutation of the C1-inhibitor (C1-INH) gene. C1-INH is a serine proteinase...

The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product (Absorica – Cipher/Ranbaxy) for treatment of severe, recalcitrant nodular acne.Isotretinoin can completely clear severe nodulocystic lesions, in some cases leading to remission that can persist for years after treatment is stopped. Mucocutaneous adverse effects include dry skin, dry eye, epistaxis, nasopharyngitis, cheilitis, alopecia, eczema, skin fragility and photosensitivity. Musculoskeletal symptoms,...