The sickle cell treatment drug Oxbryta is facing a lawsuit just months after Pfizer pulled it from the market. The lawsuit, which was filed in California, claims that the manufacturers of the drug failed to warn of the serious and potentially fatal risks of the medication.
Plaintiff Tirrell Allen, who is in his 40s, was diagnosed with sickle cell disease as a child and began using Oxbryta for treatment in August. After he started using the drug, Allen began experiencing a higher rate of vaso-occlusive crises.
According to Cleveland Clinic, a vaso-occlusive crisis (also known as a sickle cell crisis) occurs when sickled cells cause a blockage in a blood vessel. It often causes severe pain.
Allen’s lawsuit states that he also experienced swelling and other debilitating symptoms before eventually suffering a stroke in September. When his case was filed in early November, he was still hospitalized.
Allen had not known of the growing safety concerns surrounding Oxbryta that would soon lead to it being withdrawn from the market.
“Tirrell Allen was unaware that Oxbryta had a higher rate of vaso-occlusive crisis,” the lawsuit states. “He was also unaware that there were more deaths in the Oxbryta treatment group as compared to the placebo group.”
Lawyers are continuing to investigate cases for those who used Oxbryta and experienced serious side effects or complications.
Sickle Cell Drug Pulled Because ‘Benefit of Oxbryta Does Not Outweigh the Risk’
Pfizer announced in September that it was voluntarily pulling Oxbryta from the market, saying that recent data showed the benefits of the drug do not outweigh the risks.
According to the Food and Drug Administration, Pfizer’s post-market clinical trials revealed a higher rate of vaso-occlusive crises in patients taking the drug compared to the placebo group.
More deaths were also reported from the group receiving the drug.
“The safety and well-being of patients is of the utmost importance to Pfizer, and we believe this action is in the best interest of patients,” Aida Habtezion, Chief Medical Officer at Pfizer, said in a statement concerning the company’s decision to withdraw Oxbryta.
“Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options.”
The FDA first approved Obxryta in 2019 for those aged 12 and older through its accelerated approval pathway. This program accelerates market approval for drugs that fill an unmet medical need and treat serious health conditions.
Oxbryta benefited from accelerated approval again in 2021 when the FDA approved it for patients aged four to 11 as well.
“FDA understands the importance of having safe and effective medications available to improve the health of patients living with this rare, serious disease,” the agency said in its statement on Oxbryta’s discontinuation.
“There are other FDA-approved medications for the treatment of sickle cell disease, which health care professionals may prescribe as an alternative treatment to Oxbryta.”
Editor Lindsay Donaldson contributed to this article.