The FDA issued a public health advisory on March 10, 2005 warning about a risk of cancer with topical formulations of tacrolimus (Protopic) and pimecrolimus (Elidel) used to treat eczema in adults and children more than 2 years old. Elidel has been heavily promoted to the general public on television. The warning was based on reports of dose-related cancer in animals and 29 reports of cancer (including 8 skin malignancies and 12 lymphomas) in adults and children treated with these immunosuppressive drugs. Cause and effect have not been established. When Protopic was first marketed, The Medical Letter warned that the possibility of an increased risk of skin malignancies and lymphoma should be kept in mind (Med Lett Drugs Ther 2001; 43:33).

Our May 24, 2004 article on use of the immune response modulator imiquimod (Aldara) for treatment of actinic keratoses stated that no systemic effects have been detected. A physician reader objected, stating that he had developed fatigue while using the cream and had heard from dermatologists that other patients had also reported systemic effects.

Solar ultraviolet (UV) light capable of injuring the skin is classified by wavelength into UVA I (340-400 nm), UVA II (320-340 nm) and UVB (290-320 nm). UVB is responsible for most of the erythema of sunburn. UVA has been implicated in the development of phototoxicity and photoaging. The FDA permits sunscreen manufacturers to claim broad-spectrum protection if their products block at least part of UVA II in addition to UVB.

Click here to view the free full article.

Imiquimod cream 5% (Aldara - 3M), an immune modifier previously approved for treatment of genital and perianal warts (Medical Letter 1997; 39:118), has now been approved by the FDA for treatment of actinic keratoses (AKs) on the face or scalp, and may also be approved soon for treatment of basal cell carcinoma. It produces apoptosis in malignant, but not normal, human keratinocytes (M Sch÷n et al, J Natl Cancer Inst 2003; 95:1138).

While more people than ever are getting tattoos, many come to regret their decision and would like to have them removed. The technology of removing tattoos is much better than it used to be, but still far from perfect. Complete removal of all pigments with restoration of normal skin color and texture is not always possible (M Kuperman-Beade et al, Am J Clin Dermatol 2001; 2:21; GM Lipper and RR Anderson in IM Freedberg et al, eds, Fitzpatrick's Dermatology in General Medicine 6th ed, New York:McGraw-Hill 2003, page 2508).

Azelaic acid 15% gel (Finacea Berlex) is now available in the US for treatment of mild to moderate rosacea. A 20% cream formulation of the drug (Azelex Allergan; Medical Letter 1996; 38:52) has been marketed here since 1996 for treatment of acne. The effectiveness of Finacea compared to its own vehicle and to metronidazole gel is discussed. Information on the drug's mechanism of action, adverse effects, dosage and cost are also included.

Alefacept (a le' fa sept; Amevive - Biogen) has been approved by the FDA for parenteral treatment of adults with moderate to severe chronic plaque psoriasis.

Pimecrolimus 1% cream (pim e kroe' limus; SDZ ASM 981; Elidel - Novartis) has been approved by the FDA for short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients at least 2 years old.