ICN Loses Effort to Block Ribavirin ‘Hazard Alert’ : Health: Judge supports state’s choice of words to warn hospitals of the drug’s possible danger to pregnant women.

Costa Mesa-based ICN Pharmaceuticals lost a bid in Sacramento County Court on Thursday to prevent the state from issuing a “Hazard Alert” to California hospitals about the health threat that ICN’s controversial drug ribavirin may pose for pregnant women.

Officials from the Department of Health Services said they intend to issue the three-page letter today to more than 500 acute-care hospitals, where pregnant workers and visitors can be accidentally exposed to the drug, a fine white powder used to treat a seasonal childhood respiratory ailment.

The alert cites scientific studies showing that ribavirin causes birth defects in animals exposed to even low doses. It warns that the antiviral drug may accidentally escape from oxygen tents, where it is administered for long periods as an inhalant to children suffering from respiratory syncytial virus.

ICN’s primary objection to the health department action, however, had to do with the words Hazard Alert printed at the top of the letter. The phrase was “inflammatory” and would scare hospital workers into not using ribavirin, argued ICN attorney Henry Ben-Zvi of Los Angeles.

“There is a possibility that babies will die because of this,” said Ben-Zvi, in asking for a temporary restraining order against the state.

But Superior Court Judge Richard K. Park rejected the company’s arguments and denied the request.

“If there is some risk to pregnant workers, why shouldn’t they use a title that gets their attention?” Park reasoned.

The legal scuffle over ribavirin is the latest twist in the short history of a drug that, at one time, was touted as a potential treatment for persons infected with the HIV virus that causes AIDS.

Speculation over its efficacy in fighting the incurable disease has continued even though the company abandoned its efforts in March to receive Food and Drug Administration approval to market the drug to people with AIDS-related symptoms in the United States.

Despite that decision, the company announced in June that the country of Ireland had approved the sale of ribavirin to AIDS sufferers there--an announcement that touched off an immediate run on ICN stock, which hiked its value 86% in just 12 days.

Thursday’s decision in Sacramento, however, dealt strictly with the use of ribavirin to combat the childhood respiratory ailment.

Deputy Atty. Gen. Eileen Ceranowski said the health department had notified ICN as early as February about issuing an alert, and even changed some of the wording at the company’s request to say that ribavirin has been found to be a “life-saving drug” in severe cases of the respiratory virus.

She maintained, however--and the judge agreed--that the health department had every right to use the Hazard Alert phrase at the top of its letter.