Bristol-Myers Squibb, the manufacturer of Videx (ddI), has issued a stronger warning regarding the risk of pancreatitis for patients taking Videx. This warning comes after four people died from pancreatitis in a recent clinical trial of combination therapies using Videx as one of the drugs in the combination. All four of the people had T-cell counts above 500 and were taking Zerit (d4T) as a second drug in the combination. Two of the four were also taking hydroxyurea to improve the bioavailabilty of the drugs, and three of the four had a previous history of pancreatitis.
The pancreas is a gland that secretes pancreatic juice into the intestine, which is critical for proper digestion. Pancreatitis is an inflammation of the pancreas characterized by abdominal or back pain and vomiting. Inflammation of the pancreas can be caused by Videx, and careful monitoring of symptoms for pancreatitis is important when taking Videx.
The new patient package insert for Videx will include the following language:
"Pancreatitis is a dangerous inflammation of the pancreas. It may cause death! Tell your doctor right away if you or a child taking Videx develops stomach pain, nausea, or vomiting. These can be signs of pancreatitis."
Bristol-Myers Squibb discontinued the aforementioned clinical trial due to drug toxicity and the related deaths in the study resulting from pancreatitis. The FDA issued a warning letter to Bristol-Myers Squibb for failing to adequately disclose the increased toxicity related to Videx combined with hydroxyurea. To help address this issue and adequately inform physicians and patients regarding the risks of pancreatitis, the new package insert for Videx will also include a patient management section that recommends stopping the drug immediately if pancreatitis is suspected, and stopping it permanently if pancreatitis is confirmed.
Some of the known risk factors for developing pancreatitis while taking Videx are:
If you are taking Videx in combination with hydroxyurea, or have a known health risk for pancreatitis while on Videx, check with your doctor regarding ongoing monitoring and symptoms to be alert to. If you develop any of the symptoms associated with pancreatitis (such as stomach pain, nausea, or vomiting) while taking Videx, call your doctor immediately, describe the symptoms fully, and say you are on Videx. Blood tests measuring amylase lipase are usually cheeked to confirm a diagnosis of pancreatitis. Pancreatitis can be fatal if not caught and treated early, and can be prevented by stopping or changing the drug combinations.
In November 1999, the FDA approved twice-daily dosing of the protease inhibitor Nelfinavir (Viracept). Instead of 750mg three times daily, one can take 1,250mg twice daily. This eliminates that middle-of-the-day dose so often overlooked and dovetails with such other drugs commonly taken twice-daily as Combivir, 3TC, ddI and d4T.