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Update on Drugs and Drug News - Number 10 2000

Class Name/Company Approval Dates and Comments

Photodynamic Therapy

Aminolevulinic Acid
Levulan® Kerastick™ photodynamic therapy
Draxis Health/DUSA Pharmaceuticals

TPP – Canada issued marketing approval to Draxis Health in June 2001, for this product to treat AKs of the face and scalp. Draxis holds the rights to Levulan® in Canada from DUSA Pharmaceuticals.

Monoclonal Antibody

Schering Canada

TPP – Canada approved this monoclonal antibody for marketing in June 2001, for the treatment of severe, active and fistulizing Crohn’s Disease in adult patients who have not responded to conventional treatment.

Antifungal Agent

Butenafine HCl
Bertek Pharmaceuticals

The US FDA approved a new indication in June 2001, for this antifungal agent. It is now indicated for the treatment of the fungal infection tinea (pityriasis) versicolor caused by the yeast Pityrosporum orbiculare.

Antifungal Agent

Clotrimazole/Betamethasone Dipropionate
Taro Pharmaceuticals

The US FDA approved this antifungal/corticosteroid cream in May 2001, in the treatment of a variety of dermatological conditions. It is bioequivalent to Schering-Plough’s Lotrisone® cream.

Drug News

Drug Warning

The US FDA issued a warning to consumers in June 2001, to discontinue use of 13 Chinese herbal products containing aristolochic acid because they may present serious health hazards. The products are sold under the Treasure of the East label with the MFG No. 200008 and the manufacturer, Blue Light, Inc., has initiated a recall.

Drug Warning

The US FDA issued a drug warning in June 2001, stating that myelosuppression, including anemia, pancyptopenia and thrombocytopenia, has been reported in patients using Linezolid (Zyvox®). Complete blood counts should be monitored weekly in patients who receive this drug, particularly if they:

  • receive it for longer than two weeks
  • have pre-existing myelosuppression
  • receive concomitant drugs that produce bone marrow suppression
  • have chronic infections who have received previous or concomitant antibiotic therapy.

Antiacne Agent

The US FDA granted six additional months of marketing exclusivity to Accutane® (Isotretinoin, Hoffmann La Roche) in June 2001, through its pediatric exclusivity program. This means that exclusivity for Accutane® in the US is in effect until February 7, 2002.

Drug Interaction

In an article published in Clinical Pharmacology and Therapeutics*, Morii, et al, reported that when mycophenolate mofetil (CellCept®, Roche US Pharmaceuticals) and iron ion preparations were administered concomitantly, a remarkable reduction in mycophenolate mofetil absorption was observed. The authors hypothesize that this could be due to formation of a drug-iron complex in the GI tract. They recommend avoidance of simultaneous administration of these products.

*Clin Pharmacol Ther 68(6):613-6 (2000).

Oncologic Agent Re: Maxamine

The University of Pittsburgh Cancer Institute has reported that the immunomodulating agent Maxamine (histamine dihydrochloride), used in combination with interleukin-2 (IL-2), improved survival for stage IV malignant melanoma patients when compared to those treated with IL-2 alone. Preliminary results also indicated that treatment with Maxamine and IL-2 was safe and well tolerated and had substantially less toxicity than the high-dose regimens of IL-2.

Urticaria Re: Allegra

In June 2000 Aventis Pharmaceuticals announced that Allegra (fexofenadine HCl) 30mg tablets are now available by prescription for the relief of seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 6-11 years. The US FDA approved Allegra for this additional indication in February 2000.

In this issue:

  1. Aminolevulinic Acid (Levulan®) in Photodynamic Therapy of Actinic Keratoses
  2. Vulvovaginal Dryness and Itching
  3. Update on Drugs and Drug News - Number 10 2000