HIV Digest	HIV Digest Archive

Physicians and researchers have received a warning from Bristol-Myers Squibb about the risk of pancreatitis in patients taking ddI (Videx®)-- a risk which may be increased if they are also taking d4T, with or without hydroxyurea (Hydrea®).

ddI has been known to cause pancreatitis in some patients since before the drug was approved in 1991. The new warning follows four deaths from pancreatitis in recent clinical trials. All four of these patients had a CD4 count greater than 500, and a viral load less than 200 copies. All four were also taking d4T; and two of the four were in a 68-patient study arm which included ddI, d4T, and hydroxyurea (600 mg BID). Three of the four who died had known risk factors for pancreatitis before they started the treatment. If pancreatitis occurs it is important to stop the drugs and get medical attention immediately.

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The letter to researchers includes the following "Patient Management" section: "The clinical outcome of pancreatitis may be improved by early identification of the clinical and laboratory signs and symptoms of pancreatitis (abdominal pain, nausea, vomiting, elevated serum amylase and lipase levels) and prompt initiation of appropriate supportive care, including stopping all oral intake. Didanosine, stavudine and hydroxyurea should be suspended in patients with suspected pancreatitis. Reinstitution of stavudine and/or hydroxyurea after a diagnosis of confirmed pancreatitis should be undertaken with caution. Didanosine should be permanently discontinued in patients with confirmed pancreatitis.

"Some of the known risk factors for pancreatitis include: History of pancreatitis Ongoing alcohol abuse Morbid obesity Hypertriglyceridemia Chole-lithiasis Endoscopic retrograde cholangiopancreatography (ERCP) Other medications known to cause pancreatitis (e.g., pentamidine) Medications known or thought to increase exposure to didanosine (e.g. hydroxyurea, allopurinol) "In addition, patients with advanced HIV infection are at increased risk for pancreatitis and should be followed closely. When treatment with life-sustaining drugs known to cause pancreatitis is required, suspension of didanosine therapy is recommended."

The complete FDA letter to the company is available at www.fda.gov/cder/warn/oct99/8409.pdf.

Editor's Note: from AIDS Treatment News