Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H₁-antihistamine ketotifen, for prevention of ocular itch due to allergic conjunctivitis in contact lens users. This is the first approval for a drug-eluting contact lens. Ketotifen eye drops (Alaway, Zaditor, and others) are available over the counter.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

An inhaled, dry-powder formulation of rapid-acting human insulin (Exubera - Pfizer) has been approved by the FDA for treatment of adults with type 1 or type 2 diabetes.

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...

Several readers have raised questions about the statement in our recent article (Med Lett Drugs Ther 2012; 54:58) that long-acting insulins, like metformin and sulfonylureas, have been shown to decrease long-term cardiovascular risk. Our statement was based on the extension of the UKPDS (RR Holman et al, N Engl J Med 2008; 359:1577), which is the longest prospective trial of drug therapy in patients with type 2 diabetes. Shorter studies in older patients with long-standing diabetes did not find a reduction in cardiovascular risk with these and other drugs (The Action to Control Cardiovascular...

Clomipramine (Anafranil - Ciba-Geigy), a tricyclic antidepressant, is now available for treatment of obsessive compulsive disorder (OCD) in accordance with the new US Food and Drug Administration (FDA) procedure for promising investigational drugs (FE Young et al, JAMA, 259:2267, 1988). In other countries, clomipramine has been widely used for many years for treatment of depression.

Pentostatin (2'-deoxycoformycin; DCF; - Parke-Davis), a purine analog, was recently approved by the US Food and Drug Administration (FDA) for treatment of hairy-cell leukemia resistant to interferon alfa (Intron A; Roferon-A). is a rare (500 cases/year in the USA) form of chronic lymphocytic leukemia. Acutely ill patients may respond rapidly to interferon, but the drug is rarely curative. Another purine analog, 2-chlorodeoxyadenosine (CdA; Leustatin - Ortho Biotech), may also be approved soon for treatment of hairy-cell leukemia (JD Piro, Blood, 79:843, 1992). Fludarabine (Fludara...

Since the introduction of fluoxetine (Prozac - Medical Letter, 30:45, 1988), bupropion (Wellbutrin - Medical Letter, 31:97, 1989), sertraline (Zoloft - Medical Letter, 34:47, 1992) and paroxetine (Paxil - this issue), the choice of an antidepressant has become more difficult. Should these widely prescribed new drugs replace tricyclic antidepressants such as amitriptyline (Elavil, and others), imipramine (Tofranil, and others), or nortriptyline (Aventyl, and others) for treatment of most patients with depression?

Bupropion hydrochloride, currently available as an antidepressant (Wellbutrin - Medical Letter, 31:97, 1989; Wellbutrin SR), is now being marketed in a sustainedrelease formulation as Zyban (Glaxo Wellcome) for use as an aid in smoking cessation.