Health Canada Endorsed Important Safety Information on APO-CLINDAMYCIN, CLINDAMYCINE-150, and CLINDAMYCINE-300
Apotex Inc. and Pro Doc Ltée, in consultation with Health Canada, announced on May 25, 2013 that their supplier of clindamycin hydrochloride may have inadvertently caused trace amounts of the anti-psychotic drug quetiapine to be present in the clindamycin raw material. Exposure to quetiapine in patients known to be allergic should be avoided.
APO-CLINDAMYCIN, CLINDAMYCINE-150 and CLINDAMYCINE-300 contain clindamycin hydrochloride, an antibiotic, which is used to treat many infections. Some examples of uses of clindamycin are to treat infections in patients who are allergic to penicillin, in cases when other antibiotics are not effective, before dental and oral surgery.
Clindamycine is considered a medically necessary drug. As Apotex and Pro Doc currently supply about 75% of the Canadian market needs for Clindamycine, taking steps to ensure continued patient access to this medication is of utmost importance.
Trace amounts of the drug quetiapine may be present in APO-Clindamycin, Clindamycine-150 and Clindamycine-300.
For those who are allergic to quetiapine, prescription of APO-Clindamycin, Clindamycine-150 and Clindamycine-300 should be avoided.
An inspection of a Pharmaceutical Factory in China was conducted by the European Directorate for the Quality of Medicines and Healthcare (EDQM) recently. During this inspection, a concern was identified about possible contamination of clindamycin with quetiapine. This contamination may have resulted from trace amounts of quetiapine on common equipment.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious allergic reactions or other serious or unexpected adverse reactions in patients receiving APO-Clindamycin should be reported to Apotex Inc. or Health Canada.