Unlike new drugs, new techniques for surgery do not need the approval of any government agency. Laparoscopic cholecystectomy, made possible by the development of miniaturized television cameras, is one such technique that has recently attracted widespread interest (LW Way, N Engl J Med, 323:1273, Nov 1, 1990; R Winslow, Wall St J, 216:1, Dec 10, 1990).

Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

Gastrointestinal gas may cause symptoms when excessive amounts become trapped in the stomach and intestinal tract. Simethicone (Gas-X, Maalox Anti-Gas, Mylanta Gas Relief, Mylicon, Phazyme), sold over-the-counter in capsules, tablets and infant drop formulations, is being heavily advertised to the public for symptomatic treatment of flatulence and gastric bloating. According to a recent press release, 'Phazyme works fast so people can continue living active lives and eating the foods they love without fear of embarrassment.' Products that combine one or more antacids with simethicone...

Prosorba, an antibody-adsorbing column used with plasmapheresis, has been approved by the FDA for treatment of moderate-to-severe rheumatoid arthritis in patients refractory or intolerant to methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs).

Linaclotide (lin´´ a kloe´ tide; Linzess – Ironwood/Forest), a guanylate cyclase-C receptor agonist, was recently approved by the FDA for oral treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in adults. It is the second drug approved for this indication; lubiprostone (Amitiza), a metabolite of prostaglandin E1, was the first.

Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been identified as an active ingredient. Herbal supplements containing ashwagandha, which is also known as winter cherry and Indian ginseng, are widely promoted now in the US for treatment of pain, anxiety, stress, fatigue, sleep disturbances, cognitive decline, diabetes, arthritis, male infertility, and various cancers.

Transdermal fentanyl (Duragesic, and others) offers a convenient delivery system for patients with chronic pain1 but it has some drawbacks. One is that exposing the patch to heat, either from an external source, increased exertion or possibly high fever, could increase release of the drug, which might lead to an overdose and fatal respiratory depression.2 A recent article in the NY Times about this problem may have aroused the concerns of some patients using the patches.3First approved for marketing by the FDA in 19914, transdermal fentanyl provides continuous delivery of the drug for about 3...

The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.

Essure (Bayer) is the only nonsurgical, permanent contraceptive available in the US. The coil-like devices are placed hysteroscopically in both fallopian tubes and, after several months, scar tissue causes tubal occlusion.1 In 2016, the FDA required Bayer to revise the device's labeling to include a patient decision checklist and a boxed warning about the risks of uterine and fallopian tube perforation, migration of the device to the abdominal or pelvic cavity, persistent pain, and hypersensitivity reactions. Some women were apparently not being informed of these risks before implantation of...

The FDA has expanded its Emergency Use Authorization for the mRNA COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to include administration of a booster dose in children 5-11 years old who completed a primary series of the Pfizer vaccine ≥5 months previously.