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Parkinson's drug linked to hundreds of deaths

Imagine being really sick with Parkinson's disease and suffering from psychosis and hallucinations that haunt your every waking moment. The torment patients suffer leaves them and their concerned family members so desperate for relief that they are willing to try so-called "breakthrough therap[ies]" that are being fast-walked through the Food and Drug Administration (FDA) pharmaceutical review process.

But this relief may wind up killing them or their loved ones. Such is the case with one medication, Nuplazid, which was manufactured by Acadia Pharmaceuticals out of San Diego.

Safety corners cut?

In order to get Nuplazid into the hands of desperate Parkinson's patients, its FDA review was expedited. This was based on "substantial improvement" in patients suffering from serious or life-threatening diseases. The FDA advisory committee determined that the medication's potential benefits outweighed the risk.

The doctor in charge of the medical review urged caution, warning that serious outcomes could result. This included a doubled risk of death, and he was unconvinced that the six-week trial involving roughly 200 Parkinson's patients was sufficient.

Thus, Nuplazid was released nearly two years ago in June 2016.

Adverse events

Shortly thereafter, the family members and medical professionals began reporting "adverse events" with possible links to Nuplazid. They included:

  • Falls
  • Insomnia
  • Fatigue
  • Nausea
  • Life-threatening incidents
  • Deaths

Perhaps most frustrating was that there were over 1,000 reports of continued hallucinations while patients took the drug.

Just nine months later, the Institute for Safe Medication Practices (ISMP) had reported linked 244 deaths reported to the FDA to use of the medication.

The number of deaths have since climbed to 700. In 500 of those deaths, Nuplazid was the sole medicine listed as "suspect." In interviews with CNN, industry insiders shared worries that Nuplazid was approved too fast, with scant scientific evidence of its efficacy or safety.

Have you suffered a worsened medical condition or an adverse event because of a medication that you were prescribed? There may be legal avenues to explore for seeking compensation.

Source: CNN, "FDA worried drug was risky; now reports of deaths spark concern," Blake Ellis and Melanie Hicken, April 09, 2018

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