Death After Zostavax Shingles Vaccine Prompts Australian Warning

Published on March 27, 2017 by Sandy Liebhard

Australian drug regulators issued a new warning this month, after a patient died following the administration of the Zostavax shingles vaccine. The Australian Therapeutic Goods Administration (TGA) has reminded healthcare providers that Zostavax should not be used in immunocompromised patients due to the risk of serious and potentially fatal side effects.

“Health professionals should carefully consider a patient’s immunological status prior to vaccination and not administer Zostavax in immunodeficient or immunosuppressed patients,” the TGA said in a statement issued on March 7th. “If unsure, defer vaccination and seek specialist advice.”

Zostavax Side Effects

Zostavax is made with a weakened version of the varicella zoster virus, the virus that causes chickenpox. Once an individual recovers from chickenpox, the virus becomes dormant. However, varicella zoster can reactive years – or even decades – later, resulting in shingles. The U.S. Food & Drug Administration (FDA) approved Zostavax in 2006, and it is the only shingles vaccine cleared for use in this country. Originally, the Zostavax was indicated for use in patients age 60 and older. In 2011, the FDA approved use of the vaccine in adults aged 50 through 59 years.

According to Merck & Co., Zostavax has been shown to reduce the risk of shingles by just 51%. However, in August 2014, the vaccine’s label was updated to note that the Zostavax might actually cause shingles. In February 2016, the Zostavax label was modified to note reports of “Eye Disorders: necrotizing retinitis (patients on immunosuppressive therapy).”  The agency has also logged hundreds of adverse events reports involving shingles vaccines.

“Using the MedAlerts search engine, as of September 1, 2015 there had been 1,141 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with shingles containing vaccines since 1990,” according to the National Vaccine Information Center. “Over 33% of those serious shingles vaccine-related adverse events occurring in seniors 65-75 years of age. Of these shingles-vaccine related adverse event reports to VAERS 90 were deaths, with 40% of the deaths occurring in seniors over 70 years of age.”

Side effect reported in association with the shingles vaccine include: include local swelling, pain and redness at injection site; zoster-like skin rash, headache, joint pain, muscle pain, fever, abnormally swollen glands and hypersensitivity reactions.

Zostavax Lawsuits Mounting in U.S. Courts

Since the beginning of the year, state and federal courts in the U.S. have seen a growing number of Zostavax lawsuit filings by individuals who claim to have been harmed by the shingles vaccine. The majority of these cases are pending in the U.S. District Court, Eastern District of Pennsylvania. Plaintiffs allege a variety of injuries, ranging from rashes and seizures to severe outbreaks of chickenpox. One plaintiff even  claims that Zostavax caused a loved one to develop a fatal case of liver failure.

Attorneys interviewed for a report that recently appeared in The Legal Intelligencer indicated that more filings are likely.

“We are preparing to file many cases … in the court of common pleas and we will be seeking a mass tort status,” one lawyer said.

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