The FDA is requiring new warnings about peripheral neuropathy in the labeling of all oral and injectable fluoroquinolones. The potential for this class of antibiotics to cause peripheral neuropathy was first identified more than 10 years ago and a warning was added to their labels in 2004. The new warnings are based on a recent review of the FDA’s Adverse Event Reporting System (AERS) database.1The onset of peripheral neuropathy can occur rapidly, often within a few days of starting a fluoroquinolone, and in some patients the disorder may be permanent. Symptoms include pain, tingling,...

The prostaglandin alprostadil injected into the corpus cavernosum (Caverject - Upjohn) can produce an erection in some men with erectile dysfunction (Medical Letter, 37:83, 1995). Now a pellet (microsuppository) formulation has become available for intraurethral administration of alprostadil (MUSE [Medicated Urethral System for Erection] - Vivus). It is marketed in a sterile foil pouch containing a pellet 1.4 mm in diameter and 3 or 6 mm long within the stem of a hollow applicator, which is inserted 3 cm deep into the urethra. Pressing a button pushes the pellet into the urethra.

Celecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis and rheumatoid arthritis.

The RAS GTPase family inhibitor adagrasib (Krazati – BMS), which received accelerated approval for treatment of KRAS G12C (glycine-to-cysteine mutation at codon 12)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2022, has now received accelerated approval from the FDA for use with cetuximab for treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in adults who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Adagrasib is the first KRAS inhibitor to be approved in the US for treatment...

Dezocine (Dalgan - Astra), a new synthetic opioid agonist/antagonist structurally related to pentazocine (Talwin), was recently approved for parenteral use as an analgesic by the US Food and Drug Administration.

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.