Seasonale (Barr), the first "extended-cycle" oral contraceptive, is now available in the US for pregnancy prevention. Active tablets containing 30 ╡g of ethinyl estradiol and 0.15 mg of levonorgestrel are taken for 84 consecutive days, followed by 7 days of inactive tablets, allowing for withdrawal bleeding only four times a year. Other combination oral contraceptives are dispensed as 21 days of active tablets and 7 days of placebo or no tablets, resulting in 13 withdrawal bleeding episodes each year.

The FDA has licensed a 13-valent conjugate pneumococcal vaccine (PCV13; Prevnar 13 – Pfizer) for the prevention of invasive pneumococcal disease (IPD) in infants and children <6 years old. It replaces Prevnar (PCV7). An unconjugated 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23 – Merck) is FDA-approved for use in adults.

Olaratumab (Lartruvo – Lilly), a platelet-derived growth factor receptor alpha (PDGFR-α) blocking monoclonal antibody, has received accelerated approval from the FDA for use in combination with the anthracycline doxorubicin for first-line treatment of adults with soft-tissue sarcoma histologic subtypes considered susceptible to anthracyclines. Approval is limited to locally advanced or metastatic soft-tissue sarcomas that are not amenable to curative radiotherapy or surgery, and is contingent on verification of clinical benefit in a confirmatory phase 3 trial.

The FDA has approved lutetium Lu 177 dotatate (Lutathera – Advanced Accelerator Applications), a radiolabeled somatostatin analog, for treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEPNETs) in adults.

Yutiq (Eyepoint), an intravitreal implant containing the corticosteroid fluocinolone acetonide, has been approved by the FDA for treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. It is the third fluocinolone acetonide intravitreal implant to be approved in the US; Retisert, which is approved for the same indication as Yutiq, and Iluvien, which is approved for treatment of diabetic macular edema, were approved earlier. A dexamethasone intravitreal implant (Ozurdex) is approved by the FDA for treatment of noninfectious uveitis and macular...

After 53 years of dedicated service, Mark Abramowicz, M.D., President of The Medical Letter, will retire at the end of 2025.

The FDA has required manufacturers of propoxyphene-containing products (Darvon, and others) to strengthen boxed warnings to include the potential for overdose.1 This action followed disclosure of fatal overdoses linked to propoxyphene-containing products taken alone or concurrently with other CNS depressants, including alcohol. Many of the overdoses occurred in patients with a history of emotional instability or suicide attempts. Accumulation of metabolites of propoxyphene can lead to central nervous system, cardiac and respiratory depression; convulsions and cardiotoxicity have occurred.A...

The US Food and Drug Administration recently licensed a new Salk-type injectable polio vaccine (Poliovirus Vaccine Inactivated - Connaught) that is more potent in its antigenicity than any other inactivated polio vaccine (IPV) previously available in the USA. Live oral polio vaccine (OPV) has been the preferred vaccine for routine immunization in the USA since the early 1960's. Its advantages over IPV have included ease of administration, superior immunogenicity, induction of gastrointestinal immunity, increased immunization through spread of vaccine virus to unimmunized susceptible ...

The US Food and Drug Administration recently approved the marketing of a cervical cap (Prentif Cavity-Rim Cervical Cap - Lamberts Ltd, England), a contraceptive device that has been used in one form or another for many years (JP Koch, Contraception, 25:161, 1982). The cap is being distributed in the USA and Canada by Cervical Cap (CxC), Ltd, PO Box 38003-292, Los Gatos, CA 95031, telephone 408-358-6264; the distributor will make the caps available only to practitioners who have attended training seminars.

Most patients with diabetes mellitus now test their own blood glucose. In recent years, meters commercially available for self-testing have become smaller and easier to use.