Proposed Arthritis Drug Carries Life-Threatening Risks, Few Benefits, Public Citizen Warns

A prominent consumer watchdog group is warning about the potential side effects of an experimental arthritis drug being considered by federal regulators, indicating that it poses life-threatening risks, yet offers no unique benefits over other available drugs. 

On April 23, Public Citizen submitted testimony to the FDA  Arthritis Advisory Committee, urging it to recommend that the agency reject approval of an Eli Lilly drug, baricitinib, which has been introduced as a potential new rheumatoid arthritis treatment.

Director of Public Citizen’s Health Research Group, Dr. Michael Carome, told the committee that the use of baricitinib for arthritis medications lacks any unique benefit over the already FDA-approved medications containing tofacitinib. However, the committee voted 14-1 to recommend approval for a 2mg dose version of the drug. It voted 9-6 that the safety information supported approval of a dose at that size. The committee voted 10-5 against recommending approval of a stronger 4 mg dose, however.

Did You Know?

Ticketmaster Data Breach Impacts Millions of Customers

A massive Ticketmaster data breach exposed the names, addresses, phone numbers, credit card numbers and other personal information of more than 560 million customers, which have now been released on the dark web. Lawsuits are being pursued to obtain financial compensation.

Learn More

While the FDA advisory committee’s decisions are not binding, the agency often follows the recommendations when deciding whether to approve new medications.

Baricitinib was developed by both Incyte and Eli Lilly to act as an inhibitor of janus kinase, blocking the subtypes JAK1 and JAK2. Eli Lilly first introduced baricitinib as a possible arthritis treatment to the FDA in April 2017. However, agency reviewers determined it had an unfavorable risk-benefit profile.

Randomly selected clinical trials showed that baricitinib may cause potentially fatal blood clots in patients, which is a risk not seen in similar rheumatoid arthritis medications.

Data from clinical trials also led FDA reviewers to determine that a 4mg daily dose of baricitinib seems to offer only limited improvement over a lower 2mg dose. However, the larger dose raises the risk of safety issues such as pulmonary embolism and deep vein thrombosis.

Despite the FDA’s 2017 rejection, Eli Lilly resubmitted an application for approval without any new data proving the medication would not pose blood clotting risks to users, Public Citizen indicates.

Public Citizen presented findings from four pivotal randomized controlled trials which found inconsistent separations of efficacy outcomes between 2 mg and 4 mg doses. The group’s researchers also reported that side effects of the drug could range from malignancies, sustained decreased neutrophil count, opportunistic infections, tuberculosis, Herpes zoster infections and gastrointestinal perforation.

However, the group’s greatest concern was over the links to blood clot-related injuries.

“Given the available data, the only reasonable course of action for this committee and the FDA is to reject approval of the NDA for baricitinib,” Carome testified. “FDA approval, with reliance on warnings in the product labeling and postmarket pharmacovigilance, would be a reckless approach and would not be in the

interests of public health.”

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Zimmer Biomet CPT Hip System Linked to Increased Risk of Thigh Bone Fractures, FDA Warns
Zimmer Biomet CPT Hip System Linked to Increased Risk of Thigh Bone Fractures, FDA Warns (Posted today)

The FDA has issued a safety communication warning that Zimmer Biomet CPT hip system femoral stems may increase the risk of femur fractures, calling for doctors to avoid its use when possible.

Change Healthcare Data Breach Lawyers Meeting Today With MDL Judge For Initial Status Conference
Change Healthcare Data Breach Lawyers Meeting Today With MDL Judge For Initial Status Conference (Posted yesterday)

The judge presiding over all Change Healthcare lawsuits filed in federal court is holding the first status conference of the litigation, which is expected to grow significantly as Change Healthcare data breach letters continue to be sent to impacted customers.

Angiodynamics LifePort Lawsuit Filed Over Risk of the Port Catheters Failing, Causing Severe Injury
Angiodynamics LifePort Lawsuit Filed Over Risk of the Port Catheters Failing, Causing Severe Injury (Posted 2 days ago)

Complaint comes as a panel of federal judges are scheduled to hear oral arguments later this month, to determine whether all AngioDynamics port catheter lawsuits filed in U.S. District Courts nationwide should be centralized before one judge.