Tizanidine (Zanaflex - Athena Neurosciences) has been approved by the US Food and Drug Administration for oral treatment of increased muscle tone associated with spasticity. It has been available in Europe and Japan for 12 years as a short-term muscle relaxant.

A cyclosporine 0.05% ophthalmic emulsion (Restasis - Allergan) has been approved by the FDA for use in patients with dry eye disease (keratoconjunctivitis sicca). This review begins with a discussion of the causes of dry eye disease and includes sections on the pharmacology, adverse effects and clinical trial results for ophthalmic cyclosporine. Cost information and recommendations for administering the drug are also presented. The review concludes with an overall assessment of the drug's efficacy, safety and cost.

Even though it is unlikely that people living in the US will be at risk of significant radiation exposure from the nuclear accident in Japan, some readers have suggested a review of the use of potassium iodide (KI) in such circumstances. Potassium iodide taken orally before or at the time of exposure can limit or prevent uptake of radioactive iodine by the thyroid gland.

The FDA has approved tisagenlecleucel (Kymriah — Novartis), an individualized, genetically-modified cellular product, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≤25 years old. The patient's own T cells are genetically modified to express chimeric antigen receptors (CAR) and then reinfused. Kymriah is the first CAR T-cell immunotherapy to become available in the US. A CAR T-cell product for B-cell non-Hodgkin's lymphoma is expected to be approved soon.

The FDA has approved a new formulation of glucagon (Gvoke – Xeris) for subcutaneous treatment of severe hypoglycemia in patients ≥2 years old with diabetes. Conscious patients with symptoms of hypoglycemia can take oral glucose. Glucagon is usually administered by a caregiver to an unresponsive patient. The new formulation is available in a single-use prefilled syringe (Gvoke PFS) and is expected to become available in a single-use auto-injector (Gvoke HypoPen) in 2020. Unlike previously available injectable glucagon products (Glucagon Emergency Kit, and others), Gvoke does not...

Many patients ask their physicians whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamin supplements.

Cerebral arterial spasm frequently causes ischemic neurological damage after subarachnoid hemorrhage from a ruptured intracranial aneurysm. Nimodipine (Nimotop - Miles), a 1,4-dihydropyridine calcium-entry blocker, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of such patients; an intravenous preparation is available only for investigational use.

A vaccine to prevent hepatitis A (Havrix - SmithKline Beecham), previously licensed in more than 40 countries, including Canada, is now available in the United States. A similar vaccine manufactured by Merck is investigational in the USA.

Lispro insulin (Humalog - Lilly), a synthetic insulin analog, has been approved for marketing by the US Food and Drug Administration. Prepared by recombinant DNA methods using E. coli, lispro differs from human insulin in having lysine and proline at positions 28 and 29 on the beta-chain, reversed from their natural position. The new drug has biologic effects similar to unmodified insulin, but is absorbed more rapidly after subcutaneous injection.

Creatine, a natural amino acid derivative, and androstenedione, a testosterone precursor, are marketed as 'dietary supplements' in health food stores and are widely believed to enhance athletic performance. Both have been in the news recently because Mark McGwire, the baseball home-run record-setter, reportedly has said he takes both. Neither has been approved for any indication by the US Food and Drug Administration (FDA).