Safety Signals For Two Novel Drugs

This issue of QuarterWatch™ focuses on early adverse event data for two new drugs with novel mechanisms of action, and intended for difficult-to-treat patient populations: Pimavanserin (NUPLAZID), approved in April 2016, provided a new biochemical approach to treating symptoms of psychosis such as hallucinations. The combination product sacubitril-valsartan (ENTRESTO), approved in July 2015, targeted a new pathway involved in the regulation of blood pressure, and was effective in patients with already damaged hearts. However, for both drugs we observed new safety signals warranting careful consideration, and likely further action.

In 2017 Q1 the FDA received a total of 297,010 new adverse drug event reports identifying 1,445 primary suspect drugs with a median of 22 reports per drug. The report total was 8.4% higher than the previous quarter but 13.2% lower than the same quarter 1 year earlier. Figure 1 illustrates the wide variation in the number of reports submitted for each of the 1,445 drugs with 1 or more cases.  The largest group of drugs (n = 687) fell into the category of 5 to 99 reports. At the extremes, just 66 drugs had 1,000 reports or more. This small group included the two newly approved drugs examined in this report. At the other extreme, a large group of drugs (n = 367) had had so few reports (1-4 cases) that assessing a safety profile would be challenging.

QuarterWatch™ is an independent publication of the Institute for Safe Medication Practices (ISMP). We analyze computer excerpts from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). These reports (best known as MedWatch reports) are a cornerstone of the nation’s system for monitoring the safety of prescription drugs after FDA marketing approval.