Gemcitabine (jem site a been) hydrochloride (Gemzar - Lilly), a nucleoside analog, has been approved by the US Food and Drug Administration for intravenous (IV) use in the first-line treatment of locally advanced or metastatic adenocarcinoma of the pancreas and in patients with pancreatic cancer previously treated with fluorouracil (Adrucil, and others). No previously available drug has had more than minor activity in treating this disease.

Donepezil hydrochloride (Aricept - Eisai), a piperidine-based acetylcholinesterase inhibitor, is now being marketed for oral treatment of cognitive symptoms in patients with mild to moderate dementia due to Alzheimer's disease. Donepezil is the second drug approved for this indication; tacrine hydrochloride (Cognex), also an acetylcholinesterase inhibitor, has been available in the USA for four years (Medical Letter, 35:87, 1993).

Pentosan polysulfate sodium (Elmiron - Baker Norton), a semi-synthetic mucopolysaccharide structurally similar to heparin, has been approved by the US Food and Drug Administration for oral treatment of interstitial cystitis.

A reader expressed concern that a statement in our article Naloxone (Narcan) Nasal Spray for Opioid Overdose (Med Lett Drugs Ther 2016; 58:1) might be misleading. We stated that heroin has a half-life of 2-6 minutes, which is correct, but heroin is a prodrug that is rapidly metabolized to 6-acetylmorphine and morphine. The risk of respiratory depression is related to those active metabolites, and it may persist well beyond the clearance of heroin from the blood.

The FDA has required manufacturers of the oral P2Y₁₂ platelet inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta) to warn in the product labels that the absorption of these drugs may be delayed or reduced when taken with an opioid agonist.

The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.

View the Comparison Chart: Safety of Drugs for IBS in Pregnancy and Lactation

Remestemcel-L (Ryoncil – Mesoblast), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, has been approved by the FDA for treatment of steroid-refractory acute graft-versus-host disease (GVHD) in patients ≥2 months old. Steroid-refractory GVHD is associated with a poor prognosis, organ damage, and death, particularly in pediatric patients. Remestemcel-L is the first cellular therapy to be approved in the US for this indication and the only treatment of any kind to be approved for GVHD in children <12 years old.

As cocaine continues to be widely available in the USA (Medical Letter, 28:69, 1986), new problems associated with its use continue to emerge. Some recent reports indicate that use of the drug during pregnancy can damage the fetus, lead to abortion or premature labor, and cause toxic effects in the newborn infant.

Urofollitropin (Metrodin - Serono), a human gonadotropin, is the latest drug to be approved by the US Food and Drug Administration (FDA) for induction of ovulation in various clinical situations, including in vitro fertilization (IVF).