The FDA has approved the pyrimidine analog uridine triacetate (Vistogard – Wellstat Therapeutics) for emergency treatment of a fluorouracil (5-FU) or capecitabine (Xeloda, and generics) overdose or severe toxicity that occurs within 96 hours following administration of one of these drugs. Fluorouracil is a cytotoxic antimetabolite used to treat breast, colorectal, and other cancers; capecitabine is an oral prodrug of fluorouracil.Uridine triacetate, a prodrug, is deacetylated to uridine after oral administration. Excess circulating uridine is converted into uridine triphosphate, which...

Nexplanon, a single-rod contraceptive implant containing the progestin etonogestrel, has now been approved for prevention of pregnancy for up to 5 years. It was previously approved for up to 3 years of use.

Pregnant women now often receive promotional material from private cord blood banks urging them to save and store their babies' cord blood.

The Medical Letter reported last year that sildenafil (Viagra - Pfizer) appeared to be effective for idiopathic pulmonary arterial hypertension (PAH), but confirmation from a controlled trial was needed. Now the results of such a study are about to be published, and the drug has been approved by the FDA for this indication under the trade name Revatio.

The FDA has licensed Adacel (Aventis Pasteur) and Boostrix (GlaxoSmithKline), two new combination vaccines that include tetanus toxoid, diphtheria toxoid and acellular pertussis antigens (Tdap), for use as a booster in adolescents and adults. In the past, older children and adults were not re-immunized against pertussis because of concerns about reactions to the whole-cell vaccine previously used in younger children. The CDC Advisory Committee on Immunization Practices (ACIP) and the American Academy of Pediatrics (AAP) have recommended that either of the new Tdap vaccines replace routine...

Pregabalin (Lyrica - Pfizer) is the first drug approved by the FDA for management of fibromyalgia. When it was first marketed, pregabalin, which is structurally similar to gabapentin (Neurontin, and others), was approved for treatment of neuropathic pain associated with postherpetic neuralgia and diabetic peripheral neuropathy and for adjunctive treatment of partial onset seizures in adults with epilepsy. It has also been prescribed off-label for other types of neuropathic pain such as sciatica.

The FDA has licensed 4 new monovalent vaccines for prevention of respiratory illness caused by a new influenza A H1N1 virus that appears to be derived from a swine strain. The 5th vaccine should be licensed soon. All of these vaccines are expected to become available in October. An intranasal formulation is expected in the first week of October.

Recent news articles about mercury in fish may lead some patients to seek more information from their healthcare providers. For most Americans, seafood is the major source of exposure to mercury. The mercury in seafood is in the form of methylmercury, a potential neurotoxin formed by the organification of elemental mercury by marine microorganisms like plankton, which are then consumed by aquatic animals and concentrated up the food chain.

The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in another extended-release formulation (Ultram ER) and in immediate-release tablets alone (Ultram, and others) and combined with acetaminophen (Ultracet, and others).

The FDA has approved gepotidacin (Blujepa – GSK), a triazaacenaphthylene bacterial type II topoisomerase inhibitor, for oral treatment of uncomplicated urinary tract infections (uUTI) in female patients ≥12 years old who weigh ≥40 kg. Gepotidacin is the first triazaacenaphthylene antibiotic to be approved in the US.