其 他 安 全 警 示
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| The United States: FDA requires a warning about Guillain-Barré Syndrome (GBS) be included in the Prescribing Information for Shingrix (English only) |
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The US Food and Drug Administration (FDA) announces that it has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS) following administration of Shingrix. FDA required GlaxoSmithKline (GSK), the manufacturer of Shingrix, to revise the Prescribing Information to include the following language in the Warnings and Precautions section:
- In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix.
FDA evaluated data from a postmarketing observational study that assessed the risk of GBS following vaccination with Shingrix. Based on this evaluation, FDA has determined that the results of this observational study show an association of GBS with Shingrix, but that available evidence is insufficient to establish a causal relationship.
The Centers for Disease Control and Prevention (CDC) conducted postmarketing safety surveillance of Shingrix in the Vaccine Safety Datalink (VSD) by monitoring prespecified adverse events, including GBS, among individuals 50 years of age and older who received Shingrix. The VSD analyses identified a preliminary statistical signal suggesting an increased risk of GBS among individuals who received Shingrix compared to a historical control group of individuals who had received Zostavax (Zoster Vaccine Live), another FDA-approved vaccine for the prevention of shingles. To evaluate this statistical signal, FDA, the Centers for Medicare & Medicaid Services (CMS), and CDC investigated GBS risk following administration of Shingrix in the Medicare claims database. This is the largest postmarket study evaluating GBS risk following vaccination with Shingrix.
The association between vaccination with Shingrix and GBS was evaluated among Medicare beneficiaries aged 65 years or older. Using Medicare claims data, from Oct 2017 through Feb 2020, 3,729,863 vaccinations with Shingrix (administered to 2,113,758 Medicare beneficiaries) were identified through National Drug Codes, and potential cases of hospitalized GBS among recipients of Shingrix were identified through International Classification of Diseases codes.
The risk of GBS following vaccination with Shingrix was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination. The primary analysis (claims-based, all doses) found an increased risk of GBS during the 42 days following vaccination with Shingrix, with an estimated 3 excess cases of GBS per million doses administered to adults aged 65 years or older. In secondary analyses, an increased risk of GBS was observed during the 42 days following the first dose of Shingrix, with an estimated 6 excess cases of GBS per million doses administered to adults aged 65 years or older, and no increased risk of GBS was observed following the second dose of Shingrix. These analyses of GBS diagnoses in claims data were supported by analyses of GBS cases confirmed by medical record review.
FDA evaluated data from the above study, and based on this evaluation, FDA has determined that the results of this observational study show an association of GBS with Shingrix, but that available evidence is insufficient to establish a causal relationship. FDA has concluded that revision to the Warnings and Precautions section of the Prescribing Information for Shingrix to include a warning about GBS is warranted. FDA has determined that the benefits of vaccination with Shingrix continue to outweigh its risks.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-requires-warning-about-guillain-barre-syndrome-gbs-be-included-prescribing-information-shingrix
In Hong Kong, Shingrix Vaccine Powder And Suspension For Suspension For Injection (HK-66840) is a pharmaceutical product registered by GlaxoSmithKline Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to Shingrix. In light of the above FDA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Mar 25, 2021
Issued at HKT 17:00
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