In September 2024, the U.S. Food and Drug Administration (FDA) determined that the risks associated with Sickle Cell Disease drug Oxbryta may outweigh the benefits.  As a result, the FDA and Oxbryta's manufacturer, Pfizer Inc., announced a recall of all lots of Oxbryta product from the market.

FDA Recall of Oxbryta

The recall was announced after additional studies were published indicating that the overall benefit of Oxbryta to sickle cell patients did not outweigh the risks of serious adverse events.  Pfizer indicated its decision to recall Oxbryta “is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population” because the clinical data "suggest an imbalance in vaso-occlusive crises and fatal events..."

What is Oxbryta?

Oxbryta (voxelotor) is a brand name medication that was made to help people with sickle cell disease. Sickle cell disease is an inherited disorder that affects hemoglobin, making red blood cells shaped like a crescent or a “sickle” instead of being round. These oddly shaped cells can cause pain, block blood flow and lead to other health problems. Oxbryta was the first medication approved to treat sickle cell disease and works by helping red blood cells stay rounder and healthier so they can carry oxygen through the body better.

Why Was Oxbryta Recalled?

Recently, Oxbryta was recalled and the FDA advised doctors to discontinue prescribing Oxbryta. A recall is initiated when a product might be unsafe or have a problem that could harm people. The FDA was concerned about the data from studies showing more deaths in the treatment group compared to the placebo (control) group, as well as an increase in vaso-occlusive crisis in patients.

What is a Vaso-Occlusive Crisis?

A vaso-occlusive crisis (VOC) happens when the sickle-shaped red blood cells block blood flow to organs and tissues. This can cause severe pain, swelling and damage to organs. VOCs can cause:
  • Sudden, severe pain in the chest, back, legs & arms
  • Swelling of the hands and feet
  • Fever
  • Kidney failure
  • Stroke
  • Death
VOCs are considered medical emergencies that are treated with pain medication, oxygen and in some cases, blood transfusions. While Oxbryta is designed to reduce the chance of VOCs by improving red blood cell function, there is still a possibility that patients could experience VOCs while taking the medicine. If this happens, it is important to seek medical help immediately.

What Should You Do If You Took Oxbryta and Experienced a VOC or Adverse Effect?

If you or someone you know took Oxbryta and suffered a VOC or other severe adverse effect, you may be eligible for compensation.  Compensation may include your medical expenses, pain and suffering, as well as financial remuneration for any loss of earnings and future loss income. Call the attorneys at Pope McGlamry for a free consultation or submit your free case evaluation online.