Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - September 27, 1991
Karen Malone - (301) 443-3285
Foscarnet is the second drug approved for use in AIDS patients with CMV retinitis. Ganciclovir has been approved since June 1989 for treating the disease, but a significant number of patients are unable to tolerate treatment with the drug because of the adverse effects it can have on the production of critical blood cells.
Clinical studies have demonstrated that foscarnet can benefit patients with CMV retinitis. Although a clinical study comparing the relative efficacy of foscarnet to ganciclovir is underway, no definitive data are yet available. Foscarnet, like ganciclovir, is not a cure for CMV retinitis, but can significantly delay the progression of the disease.
Dr. Sullivan said, "Today's approval is the latest in a series of AIDS-related drug developments that bring renewed hope to many with AIDS. In particular, it could help improve the quality of life for those AIDS patients whose eyesight is at risk from CMV retinitis."
FDA Commissioner David A. Kessler, M.D., said, "The availablity of an alternative treatment for this disease adds a new dimension in the fight against AIDS, as it gives patients and physicians more options in combating this disease. FDA is determined to help broaden the array of drugs to treat AIDS and related conditions."
Foscarnet has been available since August 1990 to physicians treating AIDS patients with CMV retinitis who are unresponsive to ganciclovir. The drug was made available through FDA-sanctioned open study protocols sponsored by the drug's manufacturer, Astra Pharmaceutical Products, Inc., of Westborough, Mass. Astra will market the product under the trade name FOSCAVIR.
Some serious toxicity problems have been associated with foscarnet. In particular, prescribing physicians should pay very close attention to any signs of nephrotoxicity (kidney damage), abnormal electrolyte levels in the blood or seizures in patients treated with the drug.
This is the eighth drug approval for treatment of an AIDS or AIDS related condition. The other seven are:
- zidovudine (AZT) for treating infection with the AIDS virus,
- ganciclovir for the treatment of sight-threatening CMV retinitis,
- aerosolized pentamidine for use in preventing the occurrence and recurrence of Pneumocystis carinii pneumonia,
- injectable pentamidine for the treatment of Pneumocystis carinii pneumonia,
- recombinant human alfa interferon for the treatment of Kaposi's Sarcoma,
- fluconazole for the treatment of candidiasis and cryptoccocal meningitis, and
- erythropoietin for the treatment of the severe anemia sometimes associated with zidovudine treatment.
FDA is one of the Public Health Service agencies within HHS.
910927
FD910901
SOURCE: Food and Drug Administration (FDA).
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