Astemizole (Hismanal - Janssen), a new antihistamine, was recently marketed in the USA for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Like terfenadine (Seldane - Medical Letter, 27:65, 1985), astemizole is claimed to be no more sedating than placebo, but the new drug offers the advantage of a once-daily dosage schedule.

An aqueous formulation of alprostadil (prostaglandin E 1 ; - Upjohn) has been approved by the US Food and Drug Administration (FDA) for injection into the corpus cavernosum to treat erectile dysfunction. The drug is also marketed as Prostin VR, an alcohol-containing formulation, for intravenous use in newborns with congenital heart disease to maintain the patency of the ductus arteriosus.

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.

In recent months, both the lay media and some medical experts have raised concerns about the effectiveness and safety of ezetimibe, a widely used drug that prevents absorption of cholesterol from the GI tract. Ezetimibe is available alone as Zetia and in combination with 10, 20, 40 and 80 mg of simvastatin (Zocor, and others) as Vytorin.

The FDA has approved ospemifene (os pem’ i feen; Osphena – Shionogi), an estrogen agonist/antagonist, for oral treatment of moderate to severe dyspareunia in postmenopausal women. Ospemifene is the fourth estrogen agonist/antagonist to be marketed in the US, but it is the only one that has an estrogen-like effect on vaginal epithelium. The other three, tamoxifen (Nolvadex, and generics), toremifene (Fareston), and raloxifene (Evista), are used for treatment and prevention of breast cancer and osteoporosis.

The FDA has approved a higher-dose intranasal naloxone formulation (Kloxxado – Hikma) for emergency treatment of opioid overdose. A single spray of the new formulation delivers 8 mg of naloxone; a formulation that delivers 4 mg per spray (Narcan) was approved in 2015.

Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the objective response rate and duration of response.

The FDA recently warned that accidental ingestion of the antitussive benzonatate (Tessalon Perles, and others) by children less than 10 years old can be fatal.1 This widely prescribed oral agent, which has been available in the US since 1958, can also cause severe morbidity and death in older children and adults, and not only in overdosage.Benzonatate is a polyglycol derivative structurally related to procaine and tetracaine. It acts peripherally on stretch receptors in the lower respiratory tract to suppress the cough reflex. If the patient chews or sucks the liquid-filled capsules or...

The FDA has approved the marketing of fentanyl sublingual tablets (Abstral – ProStrakan) for treatment of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. It is the fourth transmucosal formulation of fentanyl to become available in the US for this indication.1-3The manufacturer recommends an initial dose of 100 mcg, a maximum of 2 doses per breakthrough pain episode, and use for no more than 4 breakthrough pain episodes per day. As with all formulations of fentanyl, strong inhibitors of CYP3A4 such as clarithromycin (Biaxin, and others)...

Some readers have objected to our recommendation (Med Lett Drugs Ther 2013; 55:55) that postmenopausal women with an intact uterus who take the oral estrogen agonist/antagonist ospemifene (Osphena) to reduce the severity of dyspareunia should also take a progestin.1 Ospemifene has agonistic effects on the endometrium, and the Osphena package insert says: "Generally, when a product with estrogen agonistic effects on the endometrium is prescribed for a postmenopausal woman with a uterus, a progestin should be considered to reduce the risk of endometrial cancer."Endometrial hyperplasia has been...