Within months of being pulled from the market and halting clinical trials, Oxbryta, a sickle cell treatment drug, is now facing a lawsuit. The case, which was filed in California, claims that the makers of the drug failed to warn about serious adverse health effects tied to its use.

Tirrell Allen, the plaintiff in the lawsuit, started taking Oxbryta in August after dealing with sickle cell for most of his life. While on the medication, he began experiencing swelling, pain and other debilitating symptoms.

He also experienced an increase in vaso-occlusive crises, which are severely painful episodes that occur when sickle-shaped cells block up blood vessels. This sometimes happens to those with sickle cell disease.

In September, Allen eventually suffered a vaso-occlusive crisis and a stroke, resulting in a prolonged hospital stay. At the time of the lawsuit’s filing in early November, he remained hospitalized.
Lawyers are continuing to investigate lawsuits involving Oxbryta and those who took the drug before it was removed from the market.

Oxbryta Discontinued Following Worrying Results from Clinical Trials

Oxbryta’s voluntary removal from the market stemmed from data uncovered in its post-market clinical trials.

Pfizer, the manufacturer of Oxbryta, made a press release statement regarding its removal. According to this statement, “Pfizer’s 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.”

Additionally, Aida Habtezion, Pfizer’s Chief Medical Officer, explained that the withdrawal is in the best interest of patient health. She advised patients to “contact their physicians to discuss alternative treatment while we continue to investigate the findings from our review of the data.”

According to the Food and Drug Administration, clinical trials showed both a higher rate of vaso-occlusive crises and deaths in those who consumed the drug compared to a group receiving a placebo.

Oxbryta initially hit the market through the FDA’s accelerated approval pathway in 2019. The agency later approved it for use with younger children through the same process. Accelerated approval is generally used for drugs that can help fill an unmet medical need or be used to treat serious conditions.

The FDA said that it is conducting a safety review of Oxbryta’s clinical trial data and may reveal additional findings at the end of the review.

Editor Lindsay Donaldson contributed to this article.