Oxbryta (Voxelotor) Sickle Cell Medication Recall

Robins Kaplan LLP is Investigating Safety Concerns of Sickle Cell Disease Medication

If you have experienced severe complications after taking Pfizer’s Oxbryta sickle cell medication, please call us at 1.800.553.9910 or complete our online contact form for a free claim evaluation.

Pharmaceutical giant Pfizer is voluntarily recalling Oxbryta from the market and is ceasing distribution because recent data indicates a diminishing benefit of Oxbryta due to safety concerns. The drugmaker states in part that the “decision 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.”¹

The U.S. Food and Drug Administration (FDA) notes side effects of Oxbryta in certain studies include more deaths in the treatment group compared to the placebo group, along with an increased rate of vaso-occlusive crisis (VOC) in patients, which is very painful and occurs when sickle-shaped red blood cells restrict blood flow and oxygen delivery to tissues.²

Who Is Affected by the Oxbryta Recall?

The FDA has advised health care professionals to discontinue prescribing Oxbryta. Initially, in 2019, the sickle cell disease (SCD) medication received accelerated approval for patients 12 years and older. Two years later, the FDA extended its approval to include patients ages 4 to 11.

Many Oxbryta users experienced vaso-occlusive events and fatal complications, including:

• Increased pain severity associated with a pain crisis (or sickle crisis)
• Disabling pain crises requiring hospitalization
• Longer hospitalizations for acute chest pain
• Stroke
• Splenic pooling and spleen removal

Contact Robins Kaplan for an Evaluation of Your Potential Case

If you have been prescribed Oxbryta and experienced severe health issues, the attorneys at Robins Kaplan may be able to help. Our experienced lawyers can help assess your case and provide crucial support while advocating for your rights.

To discuss your possible case with our team, please call 1.800.553.9910 or complete our online contact form above.