Trimetrexate glucuronate (Parke-Davis), an investigational drug, is now available in the USA from the National Institute of Allergy and Infectious Diseases (NIAID) for treatment of selected AIDS patients with Pneumocystis carinii pneumonia (PCP). For this indication, trimetrexate is always used concurrently with leucovorin (Wellcovorin; and others).

The Norplant System (Wyeth-Ayerst) for subdermal delivery of the synthetic progestin levonorgestrel was recently approved by the US Food and Drug Administration for use as a long-term contraceptive.

Quinapril (Accupril - Parke-Davis), an angiotensin-converting enzyme (ACE) inhibitor, has been approved by the US Food and Drug Administration (FDA) for treatment of hypertension. ACE inhibitors are now widely used for this indication (Medical Letter, 33:33, 1991).

Tamoxifen, anti-estrogen used for many years in the treatment of breast cancer, has now been approved by the FDA for reducing the incidence of breast cancer in women at increased risk of developing the disease.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

The thiazolidinediones rosiglitazone (Avandia) and pioglitazone (Actos) are peripheral insulin sensitizing agents used to treat hyperglycemia in patients with type 2 diabetes; one or the other is often used as a second or third agent with metformin (Glucophage, and others) and/or a sulfonylurea such as glimepiride (Amaryl, and others). A recent report suggested that rosiglitazone may increase the incidence of myocardial infarction (MI) and cardiovascular mortality.

Felodipine (Plendil - Merck), an extended-release preparation of a dihydropyridine calcium-channel blocker was recently marketed in the USA for oral treatment of hypertension. An immediate-release formulation is available in some other countries.

Acarbose (Precose -Bayer), an oral alpha-glucosidase inhibitor that has been available in Europe for several years, was recently approved by the US Food and Drug Administration (FDA) for treatment of non-insulin-dependent diabetes mellitus (NIDDM).

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.

Cerebral arterial spasm frequently causes ischemic neurological damage after subarachnoid hemorrhage from a ruptured intracranial aneurysm. Nimodipine (Nimotop - Miles), a 1,4-dihydropyridine calcium-entry blocker, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of such patients; an intravenous preparation is available only for investigational use.