Drug Firm to Alter Claims for Ribavirin at FDA Order

A Costa Mesa drug manufacturer will revise a press release for a newly approved anti-viral agent after the U.S. Food and Drug Administration criticized claims of the drug’s effectiveness as false or misleading, a company spokesman said Sunday.

“We will comply with and satisfy the concerns of the FDA,” said Dominic Liuzzi, vice president and director of corporate communications for ICN Pharmaceuticals Inc.

For the second time in agency history, the FDA has taken the unusual action of ordering the recall of a press release, this one issued by ICN Pharmaceuticals for its patented drug ribavirin, which some medical researchers say has shown promise in arresting the AIDS virus in its early stages.

FDA spokesman William Grigg said Sunday the recall was ordered late last month because the press release contained “false or misleading claims” of the drug’s effectiveness against a range of viral illnesses and minimized potentially life-threatening side effects for its only approved use in the United States.

Considered an Advertisement

Grigg said the press release was viewed as product advertisement even though it was sent only to the media and potential investors as part of a press kit announcing the FDA approval of the drug, which is sold under the trade name Virazole.

“What we’re asking (ICN) to do is send a corrected press release to all those who received the original,” said Grigg, director of press relations for the FDA, which has regulatory responsibility over advertisement of prescription drugs.

Failure to do so could result in FDA seizure of the drug for product mislabeling, Grigg said.

The FDA’s first such recall order for a press release was issued in July, 1982, for the drug Oraflex, which was widely used in the treatment of arthritis. Grigg said enforcement action was never taken because Eli Lilly & Co. pulled the drug off the market a week later over reports linking it to deaths from liver and kidney damage.

Incorporated in 1960, ICN Pharmaceuticals manufactures about 350 products and has plants and marketing operations in Mexico, Canada and Europe. It employs more than 300 in its Costa Mesa headquarters.

Treatment for Infants

Virazole, in diluted aerosol form, won FDA approval for general use last Jan. 2 in the treatment of infants suffering from respiratory syncytial virus or RSV. In February, the agency also approved clinical tests of the drug in oral form on 350 patients with pre-AIDS symptoms at nine medical centers across the nation.

In a March 24 letter to ICN Pharmaceuticals, the FDA objected to the allegedly false claim that Virazole was “so free of side effects that it could be used in premature infants,” Grigg said.

The press release failed to include the specific FDA-approved language that Virazole “is only to be used in infants who have a very serious form of the disease,” Grigg said.

“Indeed there are studies that suggest the product may have some rather serious side effects,” he said. “Severe breathing difficulties and death were reported in some of the studies of the product, and it’s not clear whether those results came from the underlying disease or from the product itself. Which is why the labeling the company agreed to says this product should be used only in very serious cases of RSV, and not in those that are rather mild.”

The FDA also objected to the following statement in the company’s January press kit to the media and investors:

“Virazole holds a great potential because of its broad-spectrum anti-viral action. The drug’s usefulness in combating respiratory syncytial virus, influenza, measles, chicken pox, herpes simplex and herpes zoster, hepatitis A, Lassa fever and sand fly fever has been demonstrated in worldwide clinical research.”

In 17 other countries where ICN Pharmaceuticals markets the drug, Liuzzi said, it has been used to inhibit reproduction of a broad spectrum of viruses.

Use of the drug as possible agent in treating Acquired Immune Deficiency Syndrome has prompted many patients with AIDS and AIDS-related complex (ARC) to buy ribavirin in Mexico.

Advertising Subject to Approval

But Grigg said that notwithstanding whether a prescription medicine has potential for wider application, manufacturers may not advertise a product for use beyond the scope of FDA approval.

“I do want to make clear that if scientists have suggestions of this product’s broader uses, they are free to discuss these sorts of things,” Grigg said.

Liuzzi said Sunday the firm will respond to the FDA by the deadline Friday and will work on a revised news release acceptable to the agency.

“We had no intention of misrepresenting the presentation of this drug” as it is approved for use by the FDA, Liuzzi said. “What we want to do is clear this matter up as quickly as possible.”