Other safety alerts
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| The United States: Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection |
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The Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate). The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS). Both patients were found to have very high olanzapine blood levels after death. Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility. The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium. FDA is providing this information to health care professionals while it continues its investigation. If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm357601.htm
In Hong Kong, there are 3 registered injectable pharmaceutical products containing olanzapine pamoate, namely Zypadhera Powder and Solvent for Suspension for Inj 405mg (HK-60692), Zypadhera Powder and Solvent for Suspension for Inj 300 mg (HK-60693) and Zypadhera Powder and Solvent for Suspension for Inj 210mg (HK-60694). They are prescription-only medicines and are registered by Eli Lilly Asia, Inc. The company has confirmed that the products have not been imported into Hong Kong since registration. The Drug Office of Department of Health will remain vigilant on new safety information related to the product issued by other regulatory authorities.
Ends/ Wednesday, June 19, 2013
Issued at HKT 16:00 |
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