Pfizer issued a global recall for Oxbryta, a sickle cell disease medication with the chemical name, voxelotor. The FDA fast-tracked Oxbryta through the “compassionate use” approval process. Compassionate drug use allows a new, unapproved drug to be used to treat a seriously ill patient when no other treatments are available. As part of this approval, the FDA and the European Medical Association required real-world clinical trials to monitor safety.
Safety Signals of Increased Deaths and Vaso-Occlusive Side Effects: Why is the test data hidden?
The clinical trials were done in the United States, United Kingdom, European Union, Egypt, Ghana, Kenya, Nigeria, Oman, and Saudi Arabia.
At the writing of this post [October 3rd, 2024], none of the clinical data has been released. However, from talking to many Oxbryta users, we are hearing reports of increased vaso-occlusive events, such as:
- Increased pain severity associated with Pain Crisis (Sickle Crisis)
- Longer hospitalizations for Acute Chest Pain
- Splenic Pooling and Spleen Removal in previously asymptomatic young children
- Stroke in an adult user who only had minimal vaso-occlusive events prior to Oxbryta
- Acute Chest Syndrome, occurring more frequently in cooler temperatures, sometimes requiring hospitalization
- Disabling Pain Crises requiring hospitalization
FDA Recall Statement Refers to Deaths and Vaso-Occlusive Crises
While the FDA does not produce the clinical data found in Oxbryta medical trials, it provided an unambiguous public statement that the drug was getting a complete, total and immediate recall.
“In postmarketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these postmarketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies. Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”
The FDA is requesting Adverse Event Reports to be made by users, which can be submitted here.
The European Medical Association Tagged Warning Flags in July 2024
The EMA spotted side effect dangers in the Oxbryta studies. They stated that they would immediately address emerging safety signals:
“Review follows reports of fatal cases in clinical trials EMA has started a review of Oxbryta (voxelotor) after data from a clinical trial showed that a higher number of deaths occurred with Oxbryta than with placebo (a dummy treatment) and another trial showed the total number of deaths was higher than anticipated.”
Questions On Oxbryta Efficacy
Patients report to us that their bloodwork did not show any noticeable improvements. Notably, one study discussing various medicines used in targeting treatment found no improvement with some issues, and reported that “…the study leading to its approval by the FDA for SCD treatment did not show any salutatory effects on VOC or acute chest syndrome frequency, nor is there evidence that the drug might be effective prophylaxis for stroke, nephropathy, or pulmonary hypertension.”
Also, clients reported an increase in non-sickle cell disease side effects as soon as they were on Oxbryta. These are typically headaches, nausea and fatigue. Prescribing doctors have often reduced doses following these symptoms.
Long-Term Oxbryta Studies Which May Be the Source of Deaths and Vaso-Occlusive Events
As stated above, neither Pfizer nor the FDA has reported the specific studies or data they are referring to. Many ongoing studies were being done that compared Oxbryta to other drugs and/or how Oxbryta affected specific sickle-cell medical conditions.
You can review these studies:
- The HOPE and RETRO studies
- Phase 3 Trial
- HOPE/Kids 2 Doppler Study
- RESOLVE Study
- The European Medical Association reports on three smaller pending, unpublished studies
Do I Qualify for a Lawsuit?
We have talked to many patients harmed by Oxbryta. Once they went on Oxbryta, side effects increased in both severity and pain. We note that these patients were very careful about staying healthy and relied on the prospects of Oxbryta providing advanced care. We believe that the hidden side-effect data will be released and will show a link to the increased side effects. For more information on litigation and lawsuit prospects, you can visit our page on Oxbryta Lawsuits.
David specializes in an active trial practice primarily involving drug products, medical device liability and product liability cases. On both a state and national level, he has obtained substantial client settlements through arbitration, mediation and direct negotiations with some of the largest national and international drug and medical device makers. David has been involved in multiple high-profile legal cases including the $2.5 billion DePuy ASR and DePuy Pinnacle metal-on-metal hip implant settlement plan and the $1.4 billion Stryker Rejuvenate metal-on-metal hip implant settlement plan.
