Health · Pharma & Biotech · 3 hrs ago
Experts raise safety concerns about Neurocrine’s Prader-Willi drug
Vykat XR treats Prader-Willi syndrome, a rare condition that can cause an insatiable feeling of hunger.
Neurocrine Biosciences makes the drug, which was approved 18 months ago.
Reports have linked its use to seven deaths and nearly 100 hospitalizations since approval.
The cases were submitted to regulators, but they do not prove Vykat XR caused the harm; many involved complex medical conditions and multiple medications.
Some experts say the evidence points to unacceptable risks, and pediatric endocrinologist and former FDA medical officer Karen Vogt is urging the FDA to withdraw the drug.
Other experts are urging caution, and no further regulatory action is specified.
Experts and patient advocates are raising concerns about the safety of Neurocrine Biosciences’ Prader-Willi syndrome drug, Vykat XR.
The drug has been linked to seven deaths and nearly 100 hospitalizations since its approval, according to reports submitted to regulators.
Those reports do not prove that Vykat XR caused the deaths or hospitalizations.
Karen Vogt, a pediatric endocrinologist and former FDA medical officer, is urging the FDA to withdraw the drug.
- Who
- Neurocrine Biosciences, which sells Vykat XR, and experts and patient advocates raising safety concerns.
- What
- Some experts say the drug may be causing unacceptable harm; Karen Vogt is urging the FDA to withdraw it.
- When
- The concerns were reported on Oct. 13, 2026; Vykat XR was approved 18 months earlier.
- Where
- Not stated.
- Why
- Reports submitted to regulators link the drug to seven deaths and nearly 100 hospitalizations, though they do not prove causality.
Experts urging withdrawal
Other experts urging caution
Evidence of harm
Experts urging withdrawal
Karen Vogt is urging the FDA to withdraw Vykat XR, and some experts say the evidence indicates unacceptable harm.
Other experts urging caution
The case reports do not prove Vykat XR caused the deaths or hospitalizations, and many cases involved complex medical issues and multiple medications.
Vykat XR was approved to treat Prader-Willi syndrome.
An open letter about potential safety issues tied to the drug was released.
STAT reported growing alarm among patient advocates and some experts.
- Drug
- Vykat XR
- Manufacturer
- Neurocrine Biosciences
- Condition treated
- Prader-Willi syndrome
- Deaths reported
- 7
- Hospitalizations reported
- Nearly 100
- Approval timing
- 18 months before Oct. 13, 2026
Sources
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