Botulinum toxin type A has been marketed in the USA since 1989 for treatment of strabismus and blepharospasm and has also been used to treat cervical dystonia and some other muscular disorders.

Rabeprazole, a benzimidazole proton pump inhibitor similar to omeprazole and lansoprazole, has been approved by the FDA for treatment of duodenal ulcers, healing and maintenance treatment of erosive or ulcerative gastroesophageal reflux disease, and for long-term treatment of chronic hypersecretory conditions, including Zollinger-Ellison syndrome

Gemtuzumab ozogamicin, a monoclonal antibody bound to a cytotoxic antibiotic, has been approved by the FDA for treatment of patients with CD33-positive acute myeloid leukemia (AML) in first relapse who are more than 60 years old and may not be able to tolerate cytotoxic chemotherapy

Methylphenidate (Ritalin, and others) is now available in a new extended-release formulation (Concerta--Alza) for treatment of attention deficit/hyperactivity disorder (ADHD).

Full-page newspaper advertisements are urging patients with high cholesterol levels who are stopping Baycol (cerivastatin) to ask their doctors about Pravachol (pravastatin), Lipitor (atorvastatin), Zocor (simvastatin) or Lescol (fluvastatin). Some advertisements come with a coupon for free medication. Lovastatin, which is available generically, has not appeared in similar advertisements. Cerivastatin was withdrawn from the market on August 8 because of post-marketing reports of 31 cases of fatal rhabdomyolysis.

An FDA Advisory Committee has recommended over-the-counter (OTC) marketing of Plan B (Barr), an emergency contraceptive "pill pack" that contains two 0.75-mg tablets of levonorgestrel to be taken 12 hours apart (Medical Letter 2000; 42:10). Plan B is one of two FDA-approved products for this indication. The Preven Emergency Contraceptive Kit (Medical Letter, 40:102, 1998) includes four tablets, each containing 0.25 mg of levonorgestrel and 50 ╡g of ethinyl estradiol; these are taken 2 at a time 12 hours apart (the "Yuzpe regimen") and are available only by...

Recombinant activated coagulation factor Vll (rFVIIa; NovoSeven - Novo Nordisk), which is marketed worldwide for treatment of bleeding episodes in hemophilia patients with inhibitors to factor VIII or IX, is now being used off-label to stop bleeding in patients who do not have hemophilia. An article in the lay press reported that one or two doses has stopped previously uncontrollable bleeding due to gunshot wounds (B Wysocki, Jr, Wall St Journal, March 17, 2004, page B1).

The phosphodiesterase type 5 (PDE5) inhibitor tadalafil (Cialis - Lilly) is now being promoted for once daily treatment of erectile dysfunction. Tadalafil differs from sildenafil (Viagra) and vardenafil (Levitra), the other PDE5 inhibitors marketed for erectile dysfunction in the US, in having a much longer duration of action.

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 required the manufacturer of Plavix, an antiplatelet drug used in addition to aspirin to prevent cardiovascular events in high-risk patients,1 to add a boxed warning to the package insert about the risk of a poor response to the drug in patients with genetic polymorphisms of the cytochrome P450 enzyme CYP2C19. Clopidogrel is a prodrug and CYP2C19 is mainly responsible for its bioactivation. The Medical Letter reported last year that several studies have found higher rates of cardiovascular events, including stent thrombosis, in patients with these polymorphisms taking...