ClassName/CompanyApproval Dates and Comments

Antiviral Agents

Valacyclovir HCl



The US FDA approved a shorter course of therapy for this antiherpes
drug in July 2001. Instead of taking Valtrex® tablets twice/day for
five days, the new 500mg. caplets can now be prescribed as a 3-day
course administered twice daily.

Anti-acne Agents

Tretinoin Gel

Retin-A® Micro® Microsphere

AP Phrama/Johnson & Johnson Canada

TPP – Canada approved this gel for marketing in Canada in July
2001, for the treatment of acne.

Oral Contraceptive

Drospirenone/Ethinyl Estradiol



The US FDA approved this low-dose monophasic, oral contraceptive
in July 2001. It is the first and only birth control pill that contains the
progestin drospirenone, which exhibits antimineralocorticoid activity
and influences water and electrolyte balance. As a result, Yasmin®
reduces sebum output and does not cause the weight gain that other
contraceptives do. Women with kidney, liver or adrenal disease should
be cautioned against taking this product.

Enzyme Replacement Therapy

Agalsidase Beta



The European Commission of the European Union granted marketing
authorization to this product in July 2001, for long-term enzyme
replacement therapy in patients with a confirmed diagnosis of Fabry

Drug News

Antibacterial Agents

In a double-blind, placebo-controlled trial, recently reported in the New England Journal of Medicine*, the
administration of a single 200mg dose of doxycycline within 72 hours after a tick bite from Ixodes scapularis
was more effective than placebo in preventing the development of Lyme disease.
*Nadelman RB, et al. N Engl J Med 345(2):79 (2001 July 12)


Rapamune® (Sirolimus, Wyeth-Ayerst Laboratories), a transplant immunosuppressant, became available in
August 2001, as a 1mg tablet for the US market in addition to the oral solution. This product is indicated for
the prevention of acute organ rejection in kedney transplant patients and is recommended for use in a
regimen that includes cyclosporine and corticosteroids.

Herbal Preparations

In an article published in the Journal of the American Medical Association*, Ang-Lee, et al, reviewed the
literature on commonly used herbal medications in the context of the perioperative period. The authors found
that complications can arise from direct effects, pharmacodynamic effects, and from pharmacokinetic
effects. Direct effects include bleeding (garlic, gingko, ginseng), cardiovascular instability (ephedra), and
hypoglycemia (ginseng). Pharmacodynamic herb-drug interactions include potentiation of the sedative effect
of anesthetics by kava and valerian and pharmacokinetic herb-drug interactions include increased
metabolism of many drugs used in the perioperative period by St. John’s wort. The authors conclude that
physicians should explicitly elicit and document a history of herbal medication use and be familiar with the
potential perioperative effects of these commonly used herbal medications.
*JAMA 286(2):208-16 (2001 Jul 11).