The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.

Amlodipine (am loe' di peen) besylate (Norvasc - Pfizer), a dihydropyridine calcium-channel blocker, has been approved by the US Food and Drug Administration for once-daily oral treatment of hypertension, chronic stable angina, and vasospastic (Prinzmetal's) angina.

Losartan potassium (Cozaar - Merck), the first angiotensin II receptor antagonist, has been approved for oral treatment of hypertension by the US Food and Drug Administration. It will be marketed both alone and in a fixed-dose combination with the diuretic hydrochlorothiazide (Hyzaar).

Repaglinide (Prandin - Novo Nordisk) is a new oral glucose-lowering agent for treating type 2 diabetes (formerly called non-insulin-dependent diabetes mellitus or NIDDM). It has been approved by the FDA for monotherapy or for use in combination with metformin.

Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.

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.

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.

Efalizumab (Raptiva - Genentech/XOMA), a humanized monoclonal antibody that inhibits T-cell activation, has been approved by the FDA for treatment of adults with moderate to severe chronic plaque psoriasis.

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.

Entecavir (Baraclude - Bristol-Myers Squibb), a nucleoside analog, has been approved by the FDA for treatment of adults with active chronic hepatitis B virus (HBV) infection.