Bristol Myers Squibbs: Videx - TheBody.com's Bulletin Boards

Fatal and non-fatal pancreatitis has occurred during therapy with didanosine when used alone or in combination regimens, regardless of the degree of immunosuppression exhibited by the patient. The incidence of pancreatitis is higher in children, elderly, in patients with advanced HIV disease, in those with a previous history of pancreatitis, and in those with risk factors for pancreatitis. Fatal pancreatitis has occurred in fewer than 1% of patients. In phase III clinical studies, pancreatitis occurred in 1—7% of patients taking the recommended dose and 1—10% of patients taking higher doses. In pediatric patients, pancreatitis occurred in 9% of patients treated at entry doses < 300 mg/m2/day and in 13% of patients treated at higher doses. Pancreatitis occurred in up to 10% of elderly patients treated in an expanded access program. In studies of didanosine plus stavudine, d4T, with or without hydroxyurea, deaths due to pancreatitis occurred in treatment-naive and treatment-experienced patients without significant immunosuppression and at the recommended doses of didanosine and stavudine. Since 1998, the majority of reported cases of pancreatitis have been in patients who were receiving stavudine in combination with didanosine with or without hydroxyurea. During post-marketing surveillance, several nonfatal cases of pancreatitis with and without lactic acidosis or hepatic failure have been reported in pregnant women receiving didanosine and stavudine. Pancreatitis generally appears within 1—6 months and can manifest as symptomatic hyperamylasemia or hemorrhagic pancreatitis. Didanosine therapy should be discontinued at the first sign of pancreatitis. Symptoms may reverse 1—3 weeks after discontinuation of didanosine. The manufacturer and the FDA request that all cases of pancreatitis occurring in patients receiving didanosine be reported to Bristol-Meyers Squibb (1—800—426—7644) and the FDA via the Medwatch program (1—800—FDA—1088).

What does this say basically?

Yes it can cause pancreatitis, and and all medications have an inherent safety risk and the benefits have to be weighed against that risk. Videx is not first line, one of the reasons is due to its side effect profile. It was one of the first generation medicines available, and at the time there were few alternatives.

Clinicians and prescribers are aware of the risks, and should discuss this with their patients AND always continue to monitor for signs.

This does not mean they are harbingers of death. Ibuprofen can cause kidney failure at certain doses and certain durations. Kidney failure leads to death. Should the makers of Motrin be accused of selling death? BMS has a warning about possible probelms and even wants cases of pancreatitis reported to them and the FDA. This is not Vioxx, no warnings have been hidden.

So I feel sorry the medicine did not agree with you. But the main point here is always make informed decisions with your doctors. Never blindly take anything!

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Words are, of course, the most potent drug used by mankind.

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