FDA Requires Warning Label for Xeljanz Over Blood Clots and Death

FDA Requires Warning Label for Xeljanz Over Blood Clots and Death

The July 26 Wall Street Journal reported that the Food and Drug Administration is requiring new safety labels for Xeljanz. The warning applies to both Xeljanz and Xeljanz XR. The warning must advise patients that the 10-milligram twice daily dose could cause higher incidents of blood clots or death. According to the WSJ story, the agency is also limiting the use of Xeljanz for treating ulcerative colitis. Patients with ulcerative colitis can only use Xeljanz if they have severe side effects from other medicines. Ulcerative colitis patients can also use the medicine if their current treatment is not effective.

The FDA does not approve the 10-milligram twice daily dose for patients with psoriatic arthritis or rheumatoid arthritis. Pfizer, the maker of Xeljanz (tofacitinib), has also said this dose of the drug is not recommended for those conditions.

The required labeling is known as a black box warning, the strictest one required by the FDA. It is used when there is evidence of a serious risk, including blood clotting and death, associated with a drug. The new requirement comes after review of a clinical trial for rheumatoid arthritis patients using different doses of the drug.

In May 2019, European regulators announced a similar warning for the twice daily 10-milligram dosage. The European Medicines Agency determined there were serious concerns of blood clots developing in the lungs of patients who:

  • have a history of blood clots or clotting disorders
  • have had heart failure or cancer
  • are taking combined hormonal contraceptives or undergoing hormone replacement therapy

This is the latest development for a drug with a long and troubled history. Xeljanz was first approved for sale in the United States by the FDA in 2012. A required post-marketing safety study indicated that high dosages of the drug caused numerous adverse reactions. The FDA recommended moving patients to the lower, 5-milligram dose, which Pfizer announced on February 19, 2019. On February 25, 2019, the FDA announced increased risks of pulmonary embolism and death in 10 mg twice daily patients.

Xeljanz patients are at risk for pulmonary embolism and deep vein thrombosis. Symptoms of pulmonary embolism include:

  • Shortness of breath
  • Sudden difficulty breathing
  • Chest pain
  • Back pain
  • Severe sweating
  • Coughing up blood
  • Clammy or bluish skin

Deep vein thrombosis symptoms include:

  • Swelling in the affected leg
  • Discoloration in the leg
  • Pain in the leg resembling a cramp
  • Warmth in the area affected

The warning announcement is one of the strongest confirmations yet of the dangers of Xeljanz. Patients who have used the drug and developed pulmonary embolism or deep vein thrombosis should seek medical attention right away. They should also note the progress of their conditions and document their treatments.

One of the allegations against Pfizer is that the drug maker failed to warn patients about the risks of Xeljanz. Others include poor research into the drug’s side effects and failure to issue safety recalls. These and other charges against the company have been or will be raised in various lawsuits over Xeljanz. The allegations raised in your case will likely depend on your specific circumstances.

Those who have been injured by Xeljanz may be entitled to compensation. Such compensation could include medical bills, lost time from work, lost earning capacity, and more. Our attorneys continue to pursue these cases and we ask for any patients hurt by Xeljanz to contact our office.

Aggressive Legal Representation You Can Count On

We expect that the medicines prescribed to us will be reasonably safe and without unnecessary health risks. Every drug has side effects. In the case of Xeljanz, there is evidence that Pfizer didn’t adequately warn about the risk of potentially life-threatening clots. You need aggressive representation to fight for the compensation you deserve. Count on Gacovino, Lake & Associates, P.C. We’re here to help those who have been injured by unsafe drugs. Contact us today to discuss your case and your legal options.

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