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FDA Issues Black Box Warning for Xeljanz and Xeljanz XR

On Behalf of | Jul 30, 2019 | FDA Alerts

In July 2019, the Food and Drug Administration (FDA) placed a Black Box Warning, the highest possible warning the FDA can mandate, on Pfizer’s blockbuster immunology drugs Xeljanz and Xeljanz XR. These new warnings will alert patients of risks including an increased risk of blood clots—and potentially, death. Here, the Baltimore pharmaceutical liability attorneys at The Law Offices of Peter Angelos detail the events that led to the FDA Black Box Warnings as well as your rights as a victim.

Rheumatoid Arthritis Drugs are Prescribed to Millions of Individuals

Rheumatoid arthritis is a common condition that can be described as a chronic inflammatory disorder affecting many joints, including those in the hands and feet. In rheumatoid arthritis, the body’s immune system attacks its own tissue, including joints. In severe cases, it attacks internal organs. Rheumatoid arthritis also affects joint linings, causing painful swelling. While there is no known cure for rheumatoid arthritis, many Americans turn to prescription drugs to help alleviate the symptoms associated with the condition, including Xeljanz and Xeljanz XR.

Xeljanz Users Exposed to Cardiovascular Risk

The FDA’s warning states that users taking the 10 mg twice daily dose of Xeljanz and Xeljanz XR are at an increased risk of developing blood clots and at an increased risk of early mortality. Pfizer first flagged the safety signal in February after an independent panel noticed higher rates of pulmonary embolism and elevated mortality rates in rheumatoid arthritis patients taking the 10-mg regimen versus those in the 5-mg group.

Patients are urged to contact their healthcare professionals if they have a history of blood clots or health problems. The FDA recommends you stop taking Xeljanz or Xeljanz XR and seek medical attention right away if you experience any unusual symptoms including:

● sudden shortness of breath,
● chest pain that worsens with breathing,
● swelling of the legs or arms,
● leg pain, swelling and tenderness or
● red or discolored skin on the legs and arms.

Speak to your health care professional before stopping use of these drugs entirely, as failure to do so can worsen your condition.

Contact a Pharmaceutical Liability Attorney at The Law Offices of Peter Angelos

As more information emerges surrounding the potential increased risk of developing blood clots as well as a multitude of life-threatening cancers and diseases while taking Xeljanz and Xeljanz XR, the legal team at The Law Offices of Peter Angelos urge you to pursue legal action if you have developed a medical issue as a result of taking this prescription drug.

The pharmaceutical liability attorneys at The Law Offices of Peter Angelos have a wealth of experience representing clients who have suffered adverse reactions as a result of taking prescription drugs and can help you receive the compensation you deserve. If you or a loved one has developed an illness or died due to complications after taking the drug Xeljanz, contact The Law Offices of Peter Angelos today.