Caution should also be exercised in a patient having intractable diarrhea or patients following a low-sodium diet. Physicians caring for these patients must perform clinical and laboratory evaluations every 7-10 days for the first 2 months of ddI therapy. Should any adverse effect of any severity be detected during this period of intensive clinical and laboratory monitoring, the physician must call Bristol-Myers Squibb (1-800-662-7999). If the patient continues ddI therapy, Bristol-Myers Squibb will require submission of follow-up and adverse experience report forms every 10 days. Although data are not available to fully assess the risks associated with the use of ddI in high-risk patients (for example, patients with preexisting disorders of body systems known to be adversely affected by ddI, particularly those with history of peripheral neuropathy, pancreatitis, seizure disorder, cardiac abnormalities, gout, and significant elevations of liver function test results), all such patients must have clinical and laboratory evaluations performed every 10 days and results submitted to Bristol-Myers Squibb on the case report forms provided.