The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The FDA has approved florbetapir F18 (flor bay´ ta pir; Amyvid – Lilly), an intravenous radioactive diagnostic agent used with positron emission tomography (PET) scans, to estimate β-amyloid neuritic plaque density in adults being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline.

The results of a recently published study suggest that taking the oral direct thrombin inhibitor dabigatran etexilate (Pradaxa) with either simvastatin (Zocor, and others) or lovastatin (Altoprev, and others) increases the risk of major hemorrhage.

The adeno-associated virus (AAV) vector-based gene therapy delandistrogene moxeparvovec-rokl (Elevidys – Sarepta) received accelerated approval from the FDA in 2023 for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. It has now received full approval for use in ambulatory patients ≥4 years old and accelerated approval for use in nonambulatory patients with DMD.

Full-page advertisements in newspapers are urging patients with type 2 diabetes coming off Rezulin to ask their doctors to switch to Avandia or Actos. Troglitazone was withdrawn from the market on March 21 because of rare but severe hepatic toxicity.

Some patients may be asking healthcare providers about the surgical techniques to enlarge the penis that are widely promoted on the Internet. Phalloplasty was first used to treat traumatic or surgical amputation (for cancer), epispadias and Peyronie's disease (JP Yurkanin et al, J Urol 2001; 166:1769).

Pantoprazole, the fourth benzimidazole proton pump inhibitor to become available in the United States, has been marketed for short-term oral treatment of erosive gastroesophageal reflux disease (GERD).

Desloratadine (des lor at' a deen; Clarinex - Schering), an active metabolite of the H1-receptor antagonist loratadine (Claritin), has been approved by the FDA for oral treatment of allergic rhinitis and chronic urticaria in patients at least 12 years old. The patent for loratadine expires in December 2002, and generic or over-the-counter versions are expected.

The FDA has approved use of gamma hydroxybutyrate (sodium oxybate is the official generic name; Xyrem - Orphan Medical) for oral treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyrate (GHB), a metabolite of gamma-aminobutyric acid (GABA), is a central-nervous-system depressant marketed in Europe for use in general anesthesia. In recent years it has been notorious for its use in "date-rape" (Medical Letter 2002; 44:21). Xyrem is a Schedule III controlled substance.

Atomoxetine (Strattera - Lilly) is the first non-stimulant drug to be approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD). Unlike other drugs approved for use in ADHD, it is not a controlled substance and is approved for use in adults as well as children. Older non-stimulant drugs that have been used to treat ADHD, although not FDA-approved, include the alpha₂-agonist clonidine (Catapres, and others) and the tricyclic antidepressant desipramine (Norpramin, and others) (Medical Letter 1996; 38:109).