Gastrointestinal gas may cause symptoms when excessive amounts become trapped in the stomach and intestinal tract. Simethicone (Gas-X, Maalox Anti-Gas, Mylanta Gas Relief, Mylicon, Phazyme), sold over-the-counter in capsules, tablets and infant drop formulations, is being heavily advertised to the public for symptomatic treatment of flatulence and gastric bloating. According to a recent press release, 'Phazyme works fast so people can continue living active lives and eating the foods they love without fear of embarrassment.' Products that combine one or more antacids with simethicone...

Glatiramer acetate (Copaxone - Teva Marion Partners), formerly known as copolymer-l, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (MS). Interferon β-1b (Betaseron) and interferon β-1a (Avonex - Medical Letter, 38:63, 1996) were previously approved for this indication.

Dolasetron (Anzemet - Hoechst Marion Roussel), a selective serotonin (5-HT3) receptor antagonist similar to ondansetron (Zofran) and granisetron (Kytril - Medical Letter, 36:61, 1994) is now available for both oral and intravenous use in prevention of nausea and vomiting due to cancer chemotherapy. A 5-HT3 antagonist plus dexamethasone (Decadron, and others) is the most effective regimen for prevention of acute vomiting caused by cancer chemotherapy. Dolasetron has also been approved by the FDA for prevention and treatment of postoperative nausea and...

Temozolomide has received accelerated approval from the FDA for oral treatment of adults with anaplastic astrocytoma that has relapsed after treatment with a nitrosourea (lomustine or carmustine) and procarbazine.

Once-a-week formulations of alendronate (Fosamax) in 35- and 70-mg tablets have now been approved by the FDA and are being heavily promoted for prevention and treatment of postmenopausal osteoporosis. A new formulation of risedronate (Actonel) for once-a-week use is under development and may be available next year.

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 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.

The FDA has approved the antiprogestin mifepristone (Korlym – Corcept Therapeutics) for control of hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome who have type 2 diabetes/ glucose intolerance and have not responded to, or are not candidates for, surgery. Formerly known as RU 486, mifepristone is also available in a lower strength as Mifeprex for use in terminating an early intrauterine pregnancy.

Probiotics are live, nonpathogenic microorganisms (usually bacteria or yeasts) marketed as dietary supplements. They have not been approved by the FDA for any indication. Since our last article on this subject, some new data have become available.

The FDA has approved Diclegis (Duchesnay), a fixed-dose, delayed-release combination of the H1-antihistamine doxylamine and the vitamin B6 analog pyridoxine, for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. It is only available by prescription. Doxylamine and pyridoxine, both currently available over the counter, were previously available by prescription in a fixed-dose combination (Bendectin) for morning sickness. Bendectin was voluntarily withdrawn in the US in 1983 because of claims of teratogenicity that have since been...