Tiopronin (Thiola - Mission), a thiol compound (mercaptopropionyl glycine) that solubilizes cystine by reacting with it to form a mixed disulfide, is now available in the USA for treatment of refractory cystinuria.

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

Many patients ask their healthcare providers 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 vitamins.

The US Department of Health and Human Services, in conjunction with the US Department of Agriculture, has released the latest update of its Dietary Guidelines (www.health.gov). The emphasis this time is on weight loss through calorie restriction and exercise. A low-fat intake is recommended; a low-carbohydrate diet is not. Fruits, vegetables and whole grains are encouraged. A review of Diet, Drugs and Surgery for Weight Loss appeared in the December 2003 issue of Treatment Guidelines from The Medical Letter.

Six years after an FDA advisory committee recommended development of a combination tablet containing an oral contraceptive and folic acid,1 the FDA has approved Beyaz (Bayer), a combination of the oral contraceptive Yaz2 with 451 mcg of levomefolate calcium, the primary metabolite of folic acid.3 According to the FDA, an unpublished double-blind, randomized U.S. trial in 379 healthy women 18-40 years old found that the combination increased serum folate levels. In an unpublished German study using a similar oral contraceptive/ levomefolate combination (summarized in the package insert), folate...

The FDA has approved a fixed-dose, orally inhaled combination of the long-acting anticholinergic tiotropium and the long-acting beta2-adrenergic agonist olodaterol (Stiolto Respimat — Boehringer Ingelheim) for long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Tiotropium (Spiriva Handihaler, Spiriva Respimat) and olodaterol (Striverdi Respimat) are also available separately for once-daily treatment of...

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.

The FDA has approved lutetium lu 177 vipivotide tetraxetan (Pluvicto – Novartis) for treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adults previously treated with androgen receptor (AR) pathway inhibitors and taxane-based chemotherapy.

Omega-3 (n-3) polyunsaturated fatty acids (PUFAs), mainly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are essential human nutrients. The main dietary source of PUFAs is fatty fish such as salmon, but small amounts may be converted from α-linolenic acid in nuts, seeds, and plant oils such as canola or flaxseed oil. An increased intake of these fatty acids has been shown to modify membrane function, inhibit thrombus formation, decrease inflammation, lower plasma triglycerides, and alter the electrical activity of the myocardium.

The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...