A new once-daily formulation of gabapentin (Gralise – Depomed) has been approved by the FDA for treatment of postherpetic neuralgia (PHN). Immediate-release (IR) gabapentin (Neurontin, and others), which has been available in the US since 1994, is also approved for this indication, but is taken three times a day. Extended-release gabapentin enacarbil (Horizant) was recently approved by the FDA for treatment of restless legs syndrome.

The results of the AIM-HIGH trial conducted by the US National Heart, Lung and Blood Institute (NHLBI) were recently published. The goal of the trial was to test whether addition of niacin to intensive statin therapy would further reduce the risk of cardiovascular disease. The trial was stopped prematurely after an average follow-up of 3 years because niacin therapy had not shown any clinical benefit.

The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Glucarpidase has been available in the US since 2007 under a compassionate use open-label treatment protocol (Clinical Trials and Consulting Services, 1-877-398-9829), which will remain in effect until the drug becomes commercially available later this year. There is currently a shortage of IV methotrexate in the US.

Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

Clopidogrel (Plavix), which prevents arterial thrombosis by inhibiting platelet activation, is commonly prescribed (usually with aspirin) for months after acute coronary syndromes and stent implantation. It may also, however, increase the risk of bleeding. Therefore, a proton pump inhibitor (PPI) such as omeprazole (Prilosec, and others) is often given concurrently to decrease the risk of gastrointestinal (GI) bleeding. Some reports have suggested that omeprazole may interfere with the antiplatelet effect of clopidogrel.

Every pharmaceutical drug is a dose-dependent poison. This article describes the clinical presentation and treatment of some dangerous overdoses commonly reported in adults.

Pravastatin - Bristol-Myers Squibb) and simvastatin (Zocor -Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have now been marketed in the USA for treatment of hypercholesterolemia. Lovastatin (Medical Letter, 29:99, 1987) is the most frequently prescribed of all cholesterol-lowering drugs in the USA. Pravastatin and simvastatin were previously reviewed in The Medical Letter when they became available in Canada (volume 33, page 18, 1991).

Flosequinan (Manoplax - Boots), a fluoroquinolone derivative, is now available in the USA for treatment of congestive heart failure. Labeling approved by the US Food and Drug Administration recommends the drug only for patients who cannot tolerate or have not responded adequately to an angiotensin-converting enzyme (ACE) inhibitor.

Ketorolac (kee' toe role ak) tromethamine 0.5%, a nonsteroidal anti-inflammatory drug (NSAID) previously available for parenteral and oral administration (Toradol - Medical Letter, 32:79, 1990), has now been approved for ophthalmic use (Acular - Allergan, Fisons) to relieve itching in seasonal allergic conjunctivitis. NSAIDs decrease prostaglandin concentrations in the eye, which theoretically might contribute to a decrease in itching. Several other NSAIDs are available for ophthalmic use in the USA, but none is marketed for this indication. Flurbiprofen (Ocufen) and suprofen (Profenal) ...

Terazosin (Hytrin - Abbott), a postsynaptic alpha 1 -adrenoreceptor blocker previ-ously available for treatment of hypertension (Medical Letter, 29:113, 1987), has now been approved by the US Food and Drug Administration (FDA) for treatment of benign prostatic hyperplasia (BPH). Although not previously approved by the FDA, terazosin and other alpha-blockers such as prazosin (Minipress, and others) or doxazosin (Car-dura) have been used for this indication for many years.