The potential emergence of viral resistance to Wellcome's Zovirax (aciclovir) is the primary barrier to a switch of the product to over-the-counter status in the USA, according to speakers at a meeting of the US Food and Drug Administration's Nonprescription Drugs & Antiviral Drugs Advisory Committees on May 19. Topical Zovirax is already available OTC in Europe for treating cold sores, but in the USA the company is seeking approval to market it OTC for genital herpes (see also page 4).
The Centers for Disease Control and other critics have opposed the switch on the resistance issue, claiming that it would endanger patients and impede doctors' ability to diagnose AIDS and other conditions that mimic or accompany genital herpes. The CDC has requested a deferral of the decision because of these concerns. If the switch is eventually approved, Zovirax will become the first systemic OTC medicine in the USA for an infectious disease. A second committee hearing will be held on July 28, before the agency comes to decision.
Randy Juhl, who is chairman of the Nonprescription Drugs Advisory Committee, said that misuse of OTC Zovirax could lead to increased viral resistance and increased morbidity, and asked the FDA to look into the ways in which the drug could be misused by consumers. These may include off-label use for cold sores, fever blisters and chickenpox, suboptimal dosing, use by first-time sufferers without a physician's diagnosis, and use to prevent transmission eg by the partners of infected patients.
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