In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
Health Canada has updated the instructions for medical use of medicinal products containing olanzapine to include the potential risk of developing syndrome of inappropriate antidiuretic hormone secretion (SIADH). SIADH is a pathological condition in which excessive secretion of antidiuretic hormone leads to water retention in the body, usually accompanied by hyponatremia. Given the vulnerability of the patient population to whom this medicinal product may be prescribed, Health Canada has taken a precautionary approach regarding the stated risks.
SIADH and the associated hyponatremia can be life-threatening or lead to a fatal outcome.
Olanzapine is indicated for the treatment of schizophrenia, related psychotic disorders, and bipolar affective disorder.
Despite the absence of a confirmed causal relationship, Health Canada, based on its analysis of the available information, could not rule out a possible association between the use of olanzapine and the development of SIADH or hyponatremia. Despite the limited evidence base, the widespread use of olanzapine in Canada became the basis for amending the package insert.
TO ANALYZE THE PUBLISHED INFORMATION, THE APPLICANT MUST USE THE ORIGINAL TEXT POSTED AT THE LINKS:
