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If you are not familiar, FDA Safety Alerts are meant to update consumers and practitioners about new side effects that have emerged in post-marketed use and were previously not found, or disclosed, on the drug’s safety label. FDA Safety Alerts can take many forms. Most are warnings about a new side effect with appropriate label change, but more serious Alerts can lead to, and include Black Box warnings and product withdrawals and recalls.

These alerts are the primary source of information that health plans, payers, and providers use to make formulary and prescribing decisions. Once an alert is issued, prescribing behavior changes accordingly.

As an example, let’s create a hypothetical drug. We'll call it Curesitall. After showing fantastic results in its phase III trial, Curesitall was approved by the FDA in January 2011. In the next several months, after being widely prescribed, reports were starting to come into the FDA Adverse Event Reporting System (FAERS) that patients taking Curesitall were also having strokes.

While some prescribing doctors heard from their peers that this was happening, the majority of them had no idea and kept prescribing it.

Time went on and Curesitall prescriptions rapidly increased, as did the number of strokes. In June of 2012 the FDA issued a Safety Alert that Curesitall had a new side-effect that needed to be put on its label-- Stroke.

Prescription rates immediately dropped. While Curesitall was an efficacious drug, there were other drugs on the market that were almost as good, but didn’t cause stroke. With that information in hand prescribing doctors were able to make a benefit-risk assessment, and most discontinued the use of Curesitall.

Unfortunately in the year and half it was on the market, before the FDA communicated the stroke issue, Curesitall caused a lot of people to go to the hospital, and many of them died. The healthcare system had to also take on the cost burden of these unnecessary hospitalizations and deaths.

Curesitall turned out to be a big problem.

What if doctors knew about the increasing number of strokes before the FDA issued an alert? Would they have made different decisions between January 2011 and June 2012?

What if health plans and payers had that information? Would they have put the drug in a different formulary tier or otherwise discouraged their providers from prescribing Curesitall?

Although this story about the hypothetical drug Curesitall is fictitious, similar stories play out every day. Real world information needs to be made available to the smart people making drug decisions, and that information needs to be shown in a way that makes it actionable.

Our research shows that in the period after a drug produces an RxSignal, leading up to an FDA alert medical costs and negative outcomes from adverse events increases by 349%. It is clear that taking action prior to an FDA alert will help reduce medical costs, and improve outcomes.

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Jim Davis

Jim Davis

Executive Vice President

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Topics: FDA, FAERS, Evidex

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.