The Food and Drug Administration Thursday gave doctors the go-ahead to treat infants suffering from a sometimes-fatal respiratory ailment with an anti-viral drug manufactured in Costa Mesa that also has shown promise in arresting the AIDS virus in its early stages.
The action technically would enable physicians to prescribe the drug, ribavirin, for AIDS victims, hundreds of whom regularly travel for treatment to Mexico, where ribavirin has been in use for six years.
The drug's manufacturer, ICN Pharmaceuticals in Costa Mesa, said preliminary tests indicated that ribavirin administered in oral doses could help arrest development of the AIDS virus.
However, there is no indication that the drug can actually cure the deadly disease, which destroys the body's immune system.
But Dr. Barry Gingell of New York, who has obtained oral doses of the drug from Mexico for some of his patients, said he believes the FDA's move would offer little relief for those suffering from AIDS because the agency approved the use of ribavirin only in aerosol form.
"It is a very dilute solution, and it would require AIDS patients to drink gallons of it," Gingell said. "Unfortunately, it is not going to help AIDS patients, and they're still going to have to go to Mexico."
The FDA approval of ribavirin was intended to allow its use in the treatment of respiratory syncytial virus, better known as RSV, a disease that strikes about 800,000 infants a year in this country and is believed to kill about 5,000 of them.
The agency said that only the most severe RSV cases would require treatment with ribavirin, which inhibits reproduction of the virus. The drug is administered through a laborious process, which requires patients to inhale an aerosol mist under an oxygen hood for 12 to 18 hours a day.
The FDA warned that, according to foreign studies, a small number of seriously ill infants being treated with ribavirin have developed pneumonia and cardiac arrest and some have died, although it was unclear whether the problems were related to the drug or the disease.
Ribavirin, marketed under the brand name Virazole, is the first major product developed by ICN Pharmaceuticals that has been certified for use in the United States.
Dominic Liuzzi, an ICN vice president, said that the drug already had been approved in 17 foreign countries. He said the firm will seek FDA approval for its use to fight several childhood and adult viral diseases, including influenza.
In addition, ICN plans further testing on 350 AIDS patients at domestic and foreign medical facilities, Liuzzi said. He predicted that sales of the drug could soar to hundreds of millions of dollars in the United States alone if the FDA eventually approves its wide-ranging use.
Faye Peterson, an FDA spokesman, said that doctors would not be restricted to prescribing ribavirin for RSV treatment. "Once a drug is approved for marketing, then a physician can use a drug for whatever he thinks is appropriate," she explained.
However, Gingell, who says he has treated at least 20 AIDS victims who have taken the drug, said it would do little good for AIDS carriers to inhale the aerosol. Gingell last year traveled to Mexico to pick up ribavirin for three patients too ill to make the trip themselves.
He cautioned that, even if the drug becomes widely available in oral form, it would not be considered a panacea because it would not neutralize the AIDS virus.