Concerns grow over safety of Neurocrine's Prader-Willi drug Vykat XR
Patient advocates and some experts are voicing growing alarm about Vykat XR, Neurocrine Biosciences' therapy for Prader-Willi syndrome, a condition that can cause an insatiable hunger. Since approval 18 months ago, the drug has been linked to seven deaths and nearly 100 hospitalizations. STAT obtained the case reports submitted to regulators through a Freedom of Information Act request. These reports do not prove the drug caused the harm, and many cases involved complex medical problems and multiple medications. Still, some experts say the evidence is enough to conclude Vykat is causing unacceptable harm. This follows an open letter on the safety concerns released two months ago.
Why it mattersYou should know that this is a warning signal, not a proven cause, and it matters most if you or someone you know is affected by Prader-Willi syndrome.
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