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If there were concerns regarding Posicors safety, why did the FDA grant approval?

April 26, 2017Approval concerns fda posicor safety

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If there were concerns regarding Posicors safety, why did the FDA grant approval?

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Despite the fact that the FDA was aware of cases of heart arrhythmia and death associated with Posicor, it was unable to confirm these reports because Roche Laboratories did not make such reports public. Instead of delaying the approval for up to a year, the FDA approved the drug despite its concerns.