The ability of grapefruit juice to increase serum concentrations of drugs was first discovered during a study of the effect of ethanol on felodipine (Plendil) pharmacokinetics. Double-strength grapefruit juice used to disguise the taste of ethanol resulted in higher than expected serum concentrations of felodipine (DG Bailey et al, Clin Invest Med 1989; 12:357).

Cetuximab (Erbitux - ImClone Systems/Bristol-Myers Squibb), an epidermal growth factor receptor (EGFR) inhibitor, and bevacizumab (Avastin - Genentech), the first vascular endothelial growth factor angiogenesis inhibitor, have recently been approved by the FDA for treatment of patients with metastatic colorectal cancer. Cetuximab is approved for treatment of patients with EGFR-expressing tumors, either in combination regimens with irinotecan (Camptosar)when the cancer has progressed on irinotecan-based therapy, or as monotherapy for those who cannot tolerate irinotecan. Bevacizumab is approved...

Tinidazole (Tindamax - Presutti Labs), an oral antiprotozoal drug similar to metronidazole (Flagyl, and others), has been approved by the FDA for treatment of trichomoniasis in adults and for treatment of giardiasis, intestinal amebiasis and amebic liver abcess in adults and children more than 3 years old. Tinidazole has been widely used outside of the US for decades under the trade name Fasigyn (Pfizer).

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), has been approved by the FDA for treatment of major depressive disorder in adults, and more recently for diabetic peripheral neuropathy as well. The Medical Letter will review its role in diabetic neuropathy in a future issue.

Acamprosate calcium (Campral - Forest) is now being marketed for oral use to maintain abstinence from alcohol. It has been used in France and other countries since 1989.

Alprazolam, a short-acting benzodiazepine, is one of the most widely prescribed drugs in the US. It is approved by the FDA for treatment of anxiety and panic disorder. An extended-release formulation, Xanax XR, which can be taken once a day, recently became available for panic disorder.

A once-daily extended-release (ER) oral formulation of the opioid analgesic hydromorphone hydrochloride (Palladone - Purdue Pharma) has been approved by the FDA for treatment of opioid-tolerant patients with persistent moderate to severe pain. Hydromorphone HCl, a semisynthetic congener of morphine and active metabolite of hydrocodone that has been used since the 1920s, is also available in immediate-release oral, injectable and suppository forms (Dilaudid, and others).

The FDA has approved a conjugated polysaccharide vaccine, Menactra (Sanofi-Pasteur), for protection against disease caused by Neisseria meningitidis in people 11-55 years old, and the manufacturer has applied for approval for use in children 2 to 10 years old. An unconjugated meningoccocal polysaccharide vaccine (Menomune - Sanofi-Pasteur) has been licensed in the US since 1981.

Dehydroepiandrosterone (DHEA), an endogenous adrenal steroid, is marketed as a dietary supplement in the US. It is widely promoted to reverse the effects of aging (loss of muscle, memory and libido) and has been used by athletes as a substitute for anabolic steroids. DHEA is banned by the International Olympic Committee, National Collegiate Athletic Association, National Football League and other sports organizations, but it was specifically exempted from becoming a controlled substance in the Anabolic Steroid Control Act of 2004.

Micafungin sodium (Mycamine - Astellas), the second echinocandin antifungal to become available in the US, has been approved by the FDA for intravenous treatment of esophageal candidiasis and prophylaxis of invasive Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT).