Federal regulators and a congressional subcommittee said Friday they are investigating allegations that a Costa Mesa drug company failed to notify authorities that its antiviral drug, Virazole, caused serious side effects among some infants.
The investigations by the Food and Drug Administration and a subcommittee of the House Energy and Commerce Committee are the latest in a string of setbacks for ICN Pharmaceuticals Inc.
The investigations come as the company is aggressively trying to convince regulators that Virazole may also have some effect against AIDS. And just last week the company confirmed that the Securities and Exchange Commission is looking into possible illegal trading of its stock.
"Certainly the company is concerned," a spokesman said about the government probes. ICN Chairman Milan Panic and President Lawrence Panitz were in Europe last week and could not be reached for comment.
(In trading on the New York Stock Exchange last week, ICN shares tumbled 25% to $17 from $22.625.)
According to a congressional staff member, the subcommittee on oversight and investigations received allegations earlier this month that ICN had failed to report adverse reactions among infants and children receiving Virazole for a rare and once-deadly lung ailment. The reactions are said to include fluid retention and heart failure.
The staff member declined to provide details of the allegations. The committee has asked the FDA for all its records on the drug and its use against the virus in infants.
Press Kit Recalled
In early 1986, the agency ordered the firm to recall and amend a press kit that it said contained "false and misleading" claims that "grossly exaggerated" Virazole's uses while minimizing its side effects.
Although the subcommittee's inquiry is focusing on the drug's use with infants, the panel is also seeking FDA information on the drug's proposed use as a treatment for patients with AIDS symptoms.
Last year, ICN asked the FDA for expedited approval to sell Virazole on a "compassionate care" basis to pre-AIDS patients, and it was one of the first companies to conduct widespread clinical trials of its drug on patients with symptoms of the disease.
In a controversial move, ICN officials disclosed in a Jan. 9 press conference that the clinical trials showed that Virazole could delay the progress of AIDS when given to patients with early signs of the disease. They said the drug was "without significant side effects."