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At the time, the FDA presented a lot of adverse event data that showed there was a risk of immunogenicity immune reactions and that raised some red flags for the committee, said Gupta, an adjunct assistant professor of anesthesiology at the Johns Hopkins University School of Medicine

There is limited data from randomized control trials and people with severe psychiatric illnesses are excluded from these trials

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In 2011, the FDA asked manufacturers to limit the amount of acetaminophen in prescription products to 325 mg per pill