Is Nuplazid really safe and effective?

The Food and Drug Administration’s criteria for approving new drugs is surprisingly simple. Manufacturers must prove that a medicine is “safe and effective” before they can market it. This is a key component of the Food, Drug, and Cosmetic Act.

The problem with this concept is that no one bothers to define what “safe” or “effective” means. This vagueness creates confusion in the minds of many consumers.

Every night on television, people watch prescription-drug commercials that mention a long list of serious drug side effects. Not infrequently, they hear about adverse reactions such as depression, suicidal thoughts, heart attacks, cancer, fatal infections and death.

The concern over drug safety and effectiveness bubbled up recently in congressional hearings on a medicine called pimavanserin (Nuplazid). It was approved by the FDA two years ago to treat hallucinations and delusions associated with Parkinson’s disease.

According to the Institute for Safe Medication Practices: “[The] FDA’s medical reviewer recommended against the approval of Nuplazid. He noted that, although other psychiatric drugs were often approved with limited evidence of benefit, in the case of Nuplazid, treatment had more than doubled the risk of death and/or serious adverse events in its only positive trial.” Three previous studies had failed to demonstrate effectiveness. Despite the FDA’s own reviewer’s objections, the agency decided that the potential benefits outweighed the risks for this drug.

Since then, concerns about this drug’s safety and effectiveness have mounted. Hundreds of people have died while taking Nuplazid. The FDA points out, however, that many of these patients were old and sick, and taking other medications as well. Consequently, the agency is investigating whether this drug was directly responsible for their deaths.

Questions also have been raised about its effectiveness. More than 1,000 reports have been submitted to the FDA claiming that the drug did not eliminate hallucinations.

U.S. Rep. Rosa DeLauro questioned the commissioner of the FDA during recent hearings: “How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?”

Commissioner Dr. Scott Gottlieb told Congress that the agency would “take another look” at the safety profile of Nuplazid. We wish the FDA would take another look at a lot of other medications as well.

If all drugs are supposed to be safe and effective, why do so many come with warnings about deadly adverse effects? The FDA seems to believe it’s off the hook as long as the official prescribing information contains cautions about potential hazards. The idea is that informed physicians and patients will be able to make balanced decisions based on this kind of data.

Long lists of scary side effects can quickly overwhelm even sophisticated patients. Frequent exposure to such recitations in commercials may desensitize people to the dangers of drugs.

The FDA considers it a patient’s responsibility to be informed about the risks of any medicine taken. In the case of Nuplazid, elderly patients who are hallucinating and may be cognitively impaired should not be expected to shoulder this burden. Even desperate family members may not be qualified to assess the balance of benefits and harms. Isn’t that what the FDA should be doing?

Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. In their column, the Graedons answer letters from readers. Write to them in care of King Features, 628 Virginia Drive, Orlando, FL 32803, or email them via their website:

2018 King Features Syndicate

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