Caduet (Pfizer), a combination of the calcium-channel blocker amlodipine (Norvasc - Pfizer) and the HMG-CoA reductase inhibitor (statin) atorvastatin (Lipitor - Pfizer), is now available in the US. It was approved by the FDA for use in patients with indications for treatment with both amlodipine, which is used to treat hypertension and/or angina pectoris, and atorvastatin, which is used to treat dyslipidemia. The combination is bioequivalent to the 2 components taken separately.

Atomoxetine (Strattera - Lilly), a nonstimulant drug that is not a controlled substance, was approved by the FDA in early 2003 for the treatment of attention deficit hyperactivity disorder (ADHD). At that time, The Medical Letter concluded that it was unclear whether atomoxetine was as effective as stimulants such as methylphenidate (Concerta, and others) (Medical Letter 2003; 45:11). Since then, the drug has been heavily advertised directly to the public for use in both children and...

Our May 24, 2004 article on use of the immune response modulator imiquimod (Aldara) for treatment of actinic keratoses stated that no systemic effects have been detected. A physician reader objected, stating that he had developed fatigue while using the cream and had heard from dermatologists that other patients had also reported systemic effects.

At a US Senate hearing prompted by the withdrawal of Vioxx, an FDA officer cited 5 drugs as potentially dangerous. It may be useful to revisit Medical Letter reviews of these drugs.

Patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) may be asking their health care providers if they should continue, and some may be asking for alternatives. For most patients taking nonspecific NSAIDs, it would be reasonable to continue. For those who are taking the COX-2 selective celecoxib (Celebrex) because they cannot tolerate the gastrointestinal (GI) effects of nonspecific NSAIDs, it seems reasonable to continue at doses no higher than 100 mg b.i.d. or 200 mg once daily; at these dosages cardiovascular risk has been no higher than with placebo. All NSAIDs, including COX-2...

Statins have been shown to reduce the risk of stroke in patients at high risk for cardiovascular disease (Treat Guidel Med Lett 2005; 3:15). A recent issue of The New England Journal of Medicine includes the results of a study sponsored by the manufacturer in which 80 mg of atorvastatin (Lipitor – Pfizer) or placebo was given to 4731 patients without coronary artery disease who had had a stroke or transient ischemic attack (TIA) within one to six months before study entry (The Stroke Prevention by Aggressive Reduction in Cholesterol Levels [SPARCL] Investigators. High-dose atorvastatin after...

Tegaserod maleate (Zelnorm – Novartis), a partial serotonin 5-HT4 receptor agonist that increases gastrointestinal motility, was approved by the FDA in 2002 for short-term treatment of constipation-predominant irritable bowel syndrome in women,1 and in 2004 for treatment of chronic constipation in adults ≤65 years old. Its efficacy has not been impressive statistically, but according to Medical Letter consultants some patients with slow-transit constipation have benefited from taking the drug. Diarrhea has been its main adverse effect.2The FDA now has requested that the manufacturer stop...

Renal colic is a common problem in emergency departments. Stones <5 mm in diameter often pass spontaneously; stones >10 mm in diameter generally do not. The usual treatment for stones that do not pass is ureteroscopy with laser lithotripsy or shockwave lithotripsy. Some clinicians have suggested that off-label use of an oral alpha-adrenergic blocker such as tamsulosin (Flomax, and others) or calcium channel blocker such as nifedipine (Procardia XL, and others) could be tried first, with or without a corticosteroid. Both adrenoreceptors and calcium channels may have a role in the...

The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

Casimersen (Amondys 45 – Sarepta), an IV antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 45 skipping (DMD-45), which occur in ~8% of DMD cases. Casimersen is the first drug to be approved for this indication and the fifth to be approved for treatment of DMD; the IV antisense oligonucleotides eteplirsen (Exondys 51), golodirsen (Vyondys 53), and viltolarsen (Viltepso) and the oral corticosteroid deflazacort (Emflaza) were...