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U.S. Department of Health and Human Services

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SangCya (Cyclosporine Oral Solution) Dear Healthcare Professional Letter Jul 2000

FDA posts safety alerts, public health advisories, press releases and other notices from companies as a service to health professionals, consumers and other interested parties. Although FDA approves medical products, FDA does not endorse either the product or the company.


This is the retyped text of a letter from SangStat Medical Corporation. Contact the company for a copy of any referenced enclosures.


July 10, 2000

Dear Health Care Professional,

On July 10 2000, SangStat Medical Corporation voluntarily recalled all lots of SangCya (Cyclosporine Oral Solution, USP (MODIFIED), 100mg/mL), 50 mL bottle, from the US wholesalers. At this time in order to allow for the orderly transitioning of patients to other products the recall is limited to the wholesale level and not extended to the pharmacy or the patient. A study in healthy volunteers has identified that SangCya is not bioequivalent to Neoral oral solution when mixed with apple juice as recommended in its labeling. SangStat is taking this Class II recall action with the knowledge of the FDA and has voluntarily withdrawn the product.

SangStat recommends the following until patients can be switched to another cyclosporine product:

  • De novo transplant patients started on SangCya (meaning patients started on SangCya at time of transplantation) and patients already stabilized on SangCya (meaning those who have been taking SangCya for more than 60 days, and have documented acceptable cyclosporine levels) may in the interim continue to use the product.
  • Transplant patients who have been switched in the last 60 days to SangCya from Neoral, and are taking their drug with apple juice should have a trough whole blood concentration drawn to confirm that this level is acceptable, if a blood level has not already been measured.
  • Patients who use apple juice as the vehicle for administration should have their trough whole blood cyclosporine concentration measured if they switch from Neoral to SangCya or vice versa.

The important thing to remember in taking cyclosporine, is to be consistent in the diluents used and in the dosing schedule with respect to meals.

If you should have any questions, please contact SangStat Medical Affairs at 1-87-SANGSTAT (1-877-2647828).

Sincerely,

RJ Tesi, MD
Senior Vice President for Strategic Development and Medical Affairs

SangStat Medical Corporation
6300 Dumbarton Circle
Fremont, CA 94555
SangStat Medical Corporation