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FDA Approves Once-Daily Dosing For Anti-HIV Drug Videx PRINCETON, NJ -- November 3, 1999 -- The U.S. Food and Drug Administration has approved once-daily dosing for Bristol-Myers Squibb's Videx® (also known as ddI), an anti-HIV drug. Videx is the first once daily nucleoside analogue reverse transcriptase inhibitor (NRTI) on the market. The new 200-mg Videx, administered in doses of two tablets once a day, will be available in December. Patients must take at least two of the appropriate strength tablets to provide adequate buffering and prevent gastric acid degradation of Videx. The medication, in combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection. Videx has remained an effective antiretroviral agent in the fight against HIV since 1991. Both fatal and nonfatal pancreatitis has occurred during therapy with Videx (didanosine) used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Videx should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Other important toxicities include retinal changes, optic neuritis and peripheral neuropathy. Patients treated with Videx in combination with stavudine, with or without hydroxyurea, may be at increased risk for adverse events such as pancreatitis, peripheral neuropathy and liver function abnormalities. The most frequent side effects observed in the combination studies (A1454- 148 and Start 2) of adults taking the recommended dose of Videx include diarrhea (69 percent, 45 percent), nausea (24 percent, 53 percent), headache (20 percent, 46 percent), vomiting (8 percent, 30 percent), rash (11 percent, 30 percent), and neuropathy (22 percent, 21 percent). Related Links: Videx (didanosine) and Bristol-Myers Squibb. E-mail this page to a friend or colleague! To print, use this version