AstraZeneca has pulled the bleeding reversal medication Andexxa off the market in the U.S. after the FDA warned about deadly blood clots.
In an update posted by on December 18, the FDA said it “considers the risks of the product to outweigh its benefits.”
This conclusion was based on 7 years of post-approval safety data, which showed an increase in thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa.
In 2018, the FDA granted accelerated approval for Andexxa as the only antidote to the blood-thinning drugs Xarelto (rivaroxaban) or Eliquis (apixaban) due to life-threatening or uncontrolled bleeding.
As a condition of accelerated approval, the FDA ordered AstraZeneca to study the risks of Andexxa in a clinical trial called ANNEXA-I.
The major safety findings included a “doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the Andexxa arm compared with usual care,” according to the FDA.
The rate of thrombosis in the Andexxa group was 14.6% versus 6.9% in patients who received the usual care. There were also 6 deaths due to thrombotic events after 30 days in patients on Andexxa, compared to just 2 deaths in the group of patients who received the usual care.
After the FDA shared its concerns with AstraZeneca, the company decided to voluntarily pull Andexxa off the U.S. market. The company said it will no longer sell or manufacture Andexxa for the U.S. market after December 22, 2025.
Andexxa is currently still approved for use by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Regulatory Agency (MHRA) on a conditional basis.
Source: AstraZeneca to pull bleeding reversal agent Andexxa after FDA flags risk imbalance