Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Questions have been raised in the US press recently about the safety of Canadian drugs. The process of drug approval in Canada is similar to that in the US (D Paul, Int J Med Marketing 2001; 1:224). More than 90% of drugs available in Canada have also been approved by the FDA. Most of these drugs come from the same manufacturers as drugs in the US. Health Canada takes longer on average to release drugs than the FDA does; more than half the drugs discontinued for safety reasons by the FDA between 1992 and 2001 had not been approved for use in Canada (NS Rawson and KI Kaitin, Ann Pharmacother...

Bivalirudin is being promoted as an intravenous (IV) anticoagulant that can be used instead of heparin in patients with unstable angina undergoing coronary angioplasty.

Echinacea, a plant also called purple coneflower, is widely used as a dietary supplement for prevention and treatment of colds.

Fondaparinux (Arixtra - Organon Sanofi-Synthelabo), a synthetic analog of heparin, has been approved by the FDA for prevention of deep vein thrombosis (DVT) after hip fracture surgery or knee or hip replacement.

Fulvestrant (Faslodex -- AstraZeneca), an estrogen receptor antagonist given intramuscularly (IM) once a month, was recently approved by the FDA for treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progession on tamoxifen (Nolvadex, and others) or another antiestrogen.

Alefacept (a le' fa sept; Amevive - Biogen) has been approved by the FDA for parenteral treatment of adults with moderate to severe chronic plaque psoriasis.

Laparoscopic surgery has become increasingly popular for the treatment of gastroesophageal reflux disease (GERD). The usual surgical procedure, a Nissen fundoplication, prevents reflux into the esophagus. The review compares medical treatment with a proton pump inhibitor vs. surgical therapy as well as open vs. the new laparoscopic technique. Morbidity and mortality with the procedures are discussed.

Low-dose aspirin is widely used as an antiplatelet drug to reduce the risk of cardiovascular disease (Medical Letter 2000; 42:18). Recent reports suggest that the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (Motrin, and others) may decrease the efficacy of aspirin for this indication. The manufacturer of Tylenol is capitalizing on these reports by advertising that aspirin-taking patients who need pain relief should use acetaminophen instead of ibuprofen.

Some Medical Letter consultants have suggested that our recent article on dermal fillers (Med Lett Drugs Ther 2007; 49:39) should have included stronger warnings about the risk of fillers that are not biodegradable, such as Artefill. The polymethylmethacrylate (PMMA, the same material that makes up Plexiglas) beads in Artefill can over time, even with the best technique, cause foreignbody granulomas and hypertrophic scarring, which may require surgical removal. Granulomas and nodules have been especially frequent when Artefill was injected into the lips. Complications are less likely with...