July 10, 2000Nationwide Recall of SangCya Oral Solution
CA (SafetyAlerts) - The
Food and Drug Administration (FDA) today announced the nationwide recall of SangCya oral
solution, a generic version of the anti-rejection drug cyclosporine (Neoral oral
solution), because of clinical evidence that the generic drug's availability is reduced
relative to Neoral oral solution if the drug is administered with apple juice.
Patients taking cyclosporine
capsules are not affected by this recall.
SangStat Medical Corporation of Fremont, California, the makers of SangCya, recently
informed the FDA about a study that was completed before the approval of the application.
The data from this clinical study showed that taking SangCya oral solution with apple
juice diminishes its absorption relative to Neoral oral solution. Because the drug's
labeling suggests that it be taken with apple or orange juice, the agency asked the
sponsor to recall the product.
Since it is recognized that some patients may be adversely affected by abruptly changing
from SangCya oral solution to another cyclosporine product, FDA will allow the product to
remain in pharmacies and hospitals. This continued availability should allow a smooth
transition of patients from the SangCya product to another cyclosporine product.
FDA is reviewing all data related to this product and will take any appropriate further
steps needed to assure the safety of patients. In the meantime, patients taking
cyclosporine oral solution should consult with their health care provider about their
taking SangCya oral solution should not change how they are taking their drug without
talking to their health care provider.
Notice of this product warning was
sent via email to SafeMail
subscribers July 10, 2000.
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