When it was first granted accelerated approval by the Food and Drug Administration for use in patients aged 12 and older in November 2019, Oxbryta seemed like it might be a miracle drug for the treatment of sickle cell disease. As time passed, though, more and more evidence came to light indicating that the cure in this case might actually have been worse than the disease, to the point that Pfizer issued a voluntary recall of the drug in September of 2024.
In particular, medical research has shown that there is a significant link between Oxbryta and “vaso-occlusive crisis,” a complication associated with sickle cell disease that can be extremely painful and potentially even life-threatening. Here is a brief overview of what this condition is, what role Oxbryta may have played in causing people to experience this condition more often than they should have, and what a skilled Oxbryta lawyer from Phillips Law Group can do to help you seek compensation for this type of harm.
What Is “Sickle Cell Crisis?”
Sickle cell disease causes the hemoglobin within red blood cells to clump together into a “sickle” shape, and a sickle cell crisis occurs when these sickle-shaped cells get stuck together inside a blood vessel and cause a blockage. There are multiple types of sickle cell crises that can affect someone with sickle cell disease, but vaso-occlusive crisis is the most straightforward and most common type, as it simply involves capillaries or other small blood vessels inside the body being clogged.
Mild sickle cell crises are often characterized by symptoms like dizziness, jaundice, fatigue, and shortness of breath, as well as a throbbing or stabbing pain in the part(s) of the body where the crisis is occurring. Depending on where the crisis happens, it can lead to serious complications like blood clots, ulcers, internal organ trauma, stroke, and even necrosis—tissue or bone death—due to a total lack of blood flow through a particular part of the body.
Evidence Linking Oxbryta to Sickle Cell Crisis
The initial appeal of Oxbryta—and the reason why the FDA fast tracked its approval for public sale—was that it helped increase the production of hemoglobin inside the bodies of people with sickle cell disease, potentially lessening the dangers of the disease as a whole. However, in 2024 studies were released which showed that the active ingredient in Oxbryta, a substance called voxelotor, was correlated with an increased risk of life-threatening vaso-occlusive crises.
In response to this, Pfizer voluntarily withdrew Oxbryta from global markets in September 2024 and discontinued all active clinical trials they were conducting into the drug. The European Medicines Agency (EMA) formally recommended the suspension of marketing authorization for Oxbryta in November of the same year. Nevertheless, the fact that Pfizer allowed this drug to go on the market in the first place with such serious design flaws likely still makes them legally liable for losses suffered by patients who experienced vaso-occlusive crises from taking Oxbryta.
An Oxbryta Attorney Can Answer Questions About the Drug’s Link to Vaso-Occlusive Crisis
Litigation over Oxbryta-related injuries and illnesses is still in the very early stages, to the point that as of December 2024 the Judicial Panel on Multidistrict Litigation has not yet made a decision about what state’s court district will handle the multidistrict litigation for Oxbryta claims. Given recent events, though, it seems very likely that more and more people will have valid grounds to file suit over the link between Oxbryta and vaso-occlusive crisis in the future.
If you have experienced serious harm from taking Oxbryta, a qualified attorney from Phillips Law Group can help you understand and proactively enforce your rights under United States law. Call today to schedule a free, no-obligation consultation with one of our legal team members.
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