New language has been added to leading shingles vaccine Shingrix over concerns that the injection may be responsible for an increased risk of a rare neurological autoimmune disease known as GBS, or Guillain-Barré Syndrome.
GBS occurs when the patient’s immune system attacks their nerve cells. It is diagnosed just 3,000 to 6,000 times a year and has been linked as a side effect of other vaccines as well, including ...
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While crafting the language for the 2011 update to the label for its flagship hair loss drug Propecia, Merck was aware of a stunning number of reports of suicide among those taking the drug. Yet today, even though the FDA has records of over 700 reports of suicide or suicidal thoughts related to Propecia or its generics, Propecia’s label makes absolutely no mention of depression ...
Now facing close to 60 lawsuits over its shingles vaccine Zostavax, Merck has petitioned for an MDL, or multidistrict litigation, to be created to help resolve the cases. 57 Zostavax lawsuits currently span nine federal courts, and the corporation only expects that number to grow. The lawsuits stem from allegations that Zostavax – marketed under the promise of preventing shingles – can actually cause the condition instead.
Zostavax ...
continue reading...After considering the data, every member of an FDA advisory panel convened this month voted to recommend the approval of Shingrix – a new shingles vaccine developed and marketed by GlaxoSmithKline.
Data was not based solely on efficacy, or effectiveness. Rather, the data also took the vaccine’s safety into consideration. Panel members were “very impressed” with that data on both fronts and – according to Reuters – believe that ...
continue reading...A lawsuit filed in mid-July seeks compensation and damages for 18 patients who claim that Merck’s anti-shingles vaccine Zostavax actually gave them the condition they were seeking to avoid. Hailing from a variety of states, the plaintiffs have come together to sue Merck in its home state of New Jersey.
Zostavax is targeted at people aged 50 years or older and the CDC has gone so far as to ...
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In a 3-0 ruling, the 3rd US Circuit Court of Appeals in Philadelphia restored the claims of several hundreds of plaintiffs against Merck for their osteoporosis drug Fosamax, according to Reuters. The plaintiffs claim the company didn’t adequately warn of the risk of thigh bone fractures that the drug may carry. Trials can now proceed on failure-to-warn claims, which a lower court originally found to be pre-empted ...
