Fentanyl buccal soluble film (Onsolis – Meda) has been approved by the FDA for treatment of breakthrough pain in adult cancer patients who are already taking and are tolerant to around-the-clock opioid therapy. It is designated as a Schedule II controlled substance Two other oral transmucosal formulations of fentanyl are already available for this indication.

Chemotherapy can result in premature menopause and infertility in young women. Pretreatment fertility counseling followed by appropriate action may prevent some of these undesirable consequences.

The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli. It is not recommended for treatment of diarrhea that is complicated by fever and/or bloody stools. Topical and injectable formulations of rifamycin have been used in Europe for other indications for many years.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

The US Department of Health and Human Services, in conjunction with the US Department of Agriculture, has released the latest update of its Dietary Guidelines (www.health.gov). The emphasis this time is on weight loss through calorie restriction and exercise. A low-fat intake is recommended; a low-carbohydrate diet is not. Fruits, vegetables and whole grains are encouraged. A review of Diet, Drugs and Surgery for Weight Loss appeared in the December 2003 issue of Treatment Guidelines from The Medical Letter.

The Medical Letter review of Palladone (hydromorphone HCl) extended-release capsules (March 14, 2005) warned that a lethal dose could be released if the new formulation was taken with alcohol. Because of that risk, the FDA asked the manufacturer (Purdue) to withdraw the drug from the market (FDA News. July 13, 2005; FDC Reports – “The Pink Sheet” July 18, 2005; 67:3).

Our article on Antiviral Drugs for Prophylaxis and Treatment of Influenza (Med Lett Drugs Ther 2005;47:93) mentioned possible use of amantadine (Symmetrel, and others) and rimantadine (Flumadine, and others), but warned that the incidence of resistance has increased substantially. The CDC recently issued a Health Alert (www.cdc.gov) saying that current evidence indicates that a high proportion of circulating influenza A viruses in the US are now resistant to amantadine and rimantadine and they should not be used for this indication, at least this year. Click here to go to this update...

The FDA has approved crofelemer (kroe fel’ e mer; Fulyzaq – Salix), a chloride channel inhibitor derived from the red sap of the South American plant Croton lechleri, for symptomatic relief of noninfectious diarrhea in patients with HIV taking antiretroviral drugs. It is the first drug approved for relief of antiretroviral-induced diarrhea and the first oral botanical drug approved by the FDA.

The FDA has approved an over-the-counter (OTC) 0.025% ophthalmic formulation of the selective alpha₂-adrenergic agonist brimonidine tartrate (Lumify – Bausch & Lomb) for treatment of ocular redness in adults and children ≥5 years old. Lumify is the first brimonidine product to be approved for OTC use.

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.