A letter correcting what federal authorities said were false and misleading claims about the drug Virazole in a press release issued by ICN Pharmaceuticals Inc. has been approved by the U.S. Food and Drug Administration and is being distributed to recipients of the original release, ICN officials said Tuesday.
The statements were made in early January in a press kit announcing the FDA's Jan. 2 approval of Virazole as a treatment for an infant respiratory ailment.
The FDA criticized ICN's claim that Virazole "was so free of side effects that it could be used in premature infants." The agency also said ICN "grossly exaggerated the efficacy of Virazole" in treating unapproved diseases.
Virazole generally is safe, but "several serious adverse events" have occurred among severely ill infants receiving the drug, stated Tuesday's correction, which is being mailed to news organizations and securities analysts.
"Although the role of Virazole aerosol in these events has not been determined, the approved labeling clearly warns against use in patients requiring assisted ventilation," the letter continued.
Before the mailing, the FDA reviewed and approved the correction, said Faye Peterson, an FDA spokeswoman.