L’FDA ha aggiunto in data 18 ottobre 2018, La MENINGITE come effetto collaterale del VACCINO VARIVAX ( VARICELLA SINGOLO ) a seguito delle segnalazioni di reazioni avverse post marketing.
We have approved your request dated April 20, 2018, to supplement your Biologics
License Application (BLA) submitted under section 351(a) of the Public Health Service
Act (42 U.S.C. 262) for Varicella Virus Vaccine Live (VARIVAX) manufactured at your
West Point, Pennsylvania facilities to revise the package insert to include the term “meningitis” in Section 6.2 Post-Marketing Experience and to clarify previously reported terms of “encephalitis” and “herpes zoster.”
6.2 Post-Marketing Experience
Broad use of VARIVAX could reveal adverse events not observed in clinical trials.
The following additional adverse events, regardless of causality, have been reported during post-marketing use of VARIVAX:
Encephalitis; cerebrovascular accident; transverse myelitis; Guillain-Barré syndrome; Bell’s palsy; ataxia; non-febrile seizures; aseptic meningitis; meningitis; dizziness; paresthesia. Cases of encephalitis or meningitis caused by vaccine strain varicella virus have been reported in immunocompetent individuals previously vaccinated with VARIVAX months to years after vaccination. Reported cases were commonly associated with preceding or concurrent herpes zoster rash.
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buongiorno Angela, tosto il tuo blog. Ti seguo
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Grazie! Cerchiamo di informare il più possibile..
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