Bristol-Myers-Squibb, manufacturer of ddI, d4T and hydroxyurea, has written to US doctors to warn them to be on the look out for cases of pancreatitis in patients with high CD4 counts taking ddI.
The warning comes after a number of reports to the US Food and Drug Administration of pancreatitis cases in people taking ddI with hydroxyurea and d4T, and four deaths from pancreatitis in clinical trials where these drugs were being tested.
Pancreatitis was identified as a potential side effect of ddI in early trials of the drug, but appears to occur less frequently with current doses and in individuals with less advanced HIV infection.
While Bristol-Myers-Squibb are concerned that use of ddI with hydroxyurea (to boost ddI levels) may result in an increased risk of pancreatitis, the company stresses that three out of the four individuals who died in clinical trials had other risk factors for pancreatitis, such as severe obesity, hypertriglycideremia and cholelithiasis. High alcohol consumption is also a risk factor for pancreatitis.
The symptoms of pancreatitis include nausea, vomiting and sharp abdominal pain, and can develop suddenly. Individuals taking ddI who experience these symptoms are advised to seek medical advice immediately, and clinicians are advised to discontinue ddI treatment permanently if pancreatitis is diagnosed.