Contact A Lawyer
Have A Potential Case Reviewed By An Attorney
Federal drug regulators have announced new warnings about the potential risk of Guillain-Barre Syndrome after a shingles vaccine, indicating side effects of Shingrix may cause the rare and serious disorder, which leaves users with muscle weakness and even paralysis.
In a drug safety communication issued this week, the FDA indicates new label warnings will be added about the potential link between Shingrix and Guillain-Barre Syndrome.
While the agency indicates there appears to be an association, the data has not yet established that the shingles vaccine causes the disorder.
Shingrix (recombinant zoster vaccine; RZV) was the second vaccine approved in the U.S. for prevention of shingles among adults, which involves two doses for inoculation. GlaxoSmithKline introduced the Shingrix vaccine in October 2017, and it has largely replaced the earlier shingles vaccine approved by the FDA in 2006, Zostavax, which involved the use of a live virus that has been linked to reports of severe shingles outbreaks and auto-immune problems.
Although Shingrix has been marketed as a safer alternative, side effects have been linked to reports of injection site reactions and other less severe problems. However, the drug maker is now being required to add new information about the potential Guillain-Barre Syndrome risk with the Shingrix vaccine, which may cause the body’s immune system to attack the nerves.
The FDA indicates the Warnings and Precautions section of the Shingrix Prescribing Information will now contain the following statement:
“In a postmarketing observational study, an increased risk of GBS (Guillain-Barre Syndrome) was observed during the 42 days following vaccination with Shingrix.”
The warning comes after a postmarketing safety surveillance of the Shingrix vaccine was conducted by the U.S. Centers for Disease Control and Prevention (CDC), which found a higher incidence rate of GBS among individuals 65 years of age or older who received the vaccine. The data came from the Vaccine Safety Datalink (VSD) and Shingrix vaccine recipients were compared to those who received the Zostavax vaccine.
The CDC estimated there are three excess cases of GBS per million doses administered to adults age 65 and older, which occurred during the first 42 days after they received the shot. The FDA said that while the data shows an association, it does not prove a causal effect, and has determined the benefits of the vaccine still outweigh the risks.
While the maker of Zostavax currently faces hundreds of shingles vaccine lawsuits filed in recent years, each involving allegations that Merck failed to adequately warn users about the potential side effects, the Shingrix manufacturer GlaxoSmithKline has not been part of the litigation. However, it appears that former user diagnosed with Guillain-Barre Syndrome may have a basis to file Shingrix lawsuits, if the drug maker knew or should have known about the risk earlier.