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Lithobid (lithium carbonate) Dear Healthcare Professional Letter Aug 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 Solvay Pharmaceuticals. Contact the company for a copy of any referenced enclosures.

August 8, 2000

Dear Healthcare Professional:

Solvay Pharmaceuticals would like to advise you of a temporary reduction in the expiration dating for Lithobid® (lithium carbonate 300 mg slow-release tablets). This change is due to Solvay's recent need to find a new source for its raw material, lithium carbonate.

The original source of lithium carbonate is no longer producing this raw material, and this problem was brought to the attention of the FDA at the end of July, 2000. Solvay has identified and tested lithium carbonate from a new source, and has now provided information on this situation to the FDA for their evaluation.

FDA review and approval of changes affecting raw materials for prescription drug products is a standard practice in assuring the continued supply of safe and effective drugs to the US population. This includes the assessment of quality data to support the shelf-life of the drug products made using these raw materials.

There are limited data currently available on Lithobid® Tablets manufactured with raw material from the new source. In order to address public health concerns surrounding a potential out-of-stock situation, the FDA is not restricting the distribution of Lithobid® Tablets prior to the availability of full stability information. However, FDA is presently requiring that the new Lithobid® Tablets carry a shorter, provisional expiration date of six (6) months, while longer term data are acquired and evaluated.

Because of diminished inventories of Lithobid® Tablets made with the originally approved raw material, and the potential for short-term depletion of stocks as the new Lithobid® Tablets come into distribution. Solvay, together with FDA, recommends certain practices to assist healthcare professionals in maintaining their patients on appropriate medication. Specifically, we suggest the following:

  • Limit prescriptions of Lithobid® Tablets to quantities of no more than 30 days (refillable prescriptions are acceptable).
  • Be aware of alternative medications and/or other formulations of lithium to treat manic depressive illness.
  • Be aware that, as with any lithium formulation, it is importantto closely monitor blood levels when initiating and changing therapeutic regimens.

Solvay appreciates and wishes to acknowledge the close cooperative working relationship with FDA which has allowed us to help maintain adequate supplies of this medically important product.

Solvay is continuing to collect additional stability data and is confident that product expiration dating will be able to be extended in due time. Solvay is also aggressively pursuing additional back up sources of raw material to minimize the potential for future shortages.

Follow-up communication will be forthcoming, as additional information becomes available.

If you have any questions, please call Solvay Customer Service at 1-800-241-1643; press option 6 and then option 5.

Best personal regards,

Harold H. Shlevin, Ph.D
President & Chief Executive Officer

Solvay Pharmaceuticals, Inc.
901 Sawyer Road
Marietta, GA 30062
Phone: 770.578.5740