Use of epoetin alfa, a recombinant human erythropoietin, is being promoted directly to consumers in vague advertisements that promise renewed energy and improved work capacity. Epoetin is approved by the FDA for treatment of anemia due to chronic renal failure, cancer chemotherapy or HIV treatment, and before elective non-cardiac surgery. It is also used illicitly by competitive athletes to increase their endurance.

Botulinum toxin type A (Botox Cosmetic - Allergan) has received formal approval from the FDA for treatment of glabellar ("frown") lines in adults not more than 65 years old, and is being heavily advertised. Even before this approval, cosmetic use of botulinum toxin to reduce wrinkles on the face and neck had become a popular alternative to cosmetic surgery (Medical Letter 1999; 41:63). Botulinum toxin type A (Botox) and type B (Myobloc) are approved for treatment of cervical dystonia (Medical Letter 2001; 43:53), and type A has been approved since 1989 for treatment of strabismus and...

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

High plasma homocysteine concentrations, like high cholesterol, have been associated with an increased risk of cardiovascular disease and death (O Nygσrd et al, N Engl J Med 1997; 337:230; RS Vasan et al, JAMA 2003; 289:1251). In one meta-analysis, 25% lower plasma homocysteine concentrations were associated with 11% less coronary heart disease and 19% less stroke (Homocysteine Studies Collaboration, JAMA 2002; 288:2015). Should we be trying to lower serum homocysteine concentrations in our patients?

Epinastine HCl, an H₁-receptor antagonist and mast cell stabilizer, has been approved by the FDA for use in a 0.05% ophthalmic solution (Elestat - Allergan/Inspire) for prevention of itching associated with allergic conjunctivitis. The drug is available orally in Europe and Asia.

The FDA has approved pegaptanib sodium (Macugen - Pfizer/Eyetech) as an intravitreous injection for treatment of all subtypes of neovascular (wet) age-related macular degeneration (AMD). The only other approved treatment for this condition is photodynamic therapy with intravenous verteporfin (Visudyne), which is recommended only for patients with one subtype (predominantly classic) of neovascular AMD.

Femcon Fe (Warner Chilcott) is being advertised as the world's only chewable oral contraceptive. It was formerly marketed as Ovcon 35 Fe. Each packet provides 21 tablets containing 0.4 mg norethindrone and 35 mcg ethinyl estradiol, and 7 tablets with only 75 mg of ferrous fumarate. Femcon Fe has the same active hormonal ingredients as Ovcon 35 (Warner Chilcott), which has been available since 1976, and its generic equivalent Balziva (Barr); neither formulation contains iron. The spearmint-flavored Femcon Fe pill can be chewed or swallowed whole. According to the package labeling, if the pill...

The FDA has approved calcitriol ointment (Vectical - Galderma), a vitamin D analog, for topical treatment of mild-to-moderate plaque psoriasis in adults ≥18 years old. Ointments are generally considered more potent than creams or solutions.

Combination oral contraceptives increase the risk of venous thromboembolism (VTE). Their benefits, in addition to preventing pregnancy, include lowering the risk of ovarian and endometrial cancer, reducing dysfunctional uterine bleeding and increasing serum hemoglobin concentrations. Are these benefits worth the risk? And are some combination oral contraceptives safer than others?

The FDA has approved pralatrexate (Folotyn – Allos), an intravenous (IV) antifolate, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the first drug approved by the FDA specifically for this indication.