The Food and Drug Administration is requiring a new warning label for Xeljanz, reports the July 26 Wall Street Journal. Included in the requirement is both Xeljanz and Xeljanz XR. Patients must be warned that the 10-milligram twice daily dose could increase the likelihood of blood clots or death. The FDA is also limiting the use of Xeljanz for treating ulcerative colitis, according to the WSJ. Xeljanz is only approved for ulcerative colitis patients who have severe side effects from other medicines. Ulcerative colitis patients can also use Xeljanz if their current treatment is not effective.
The new label is called a black box warning, which is the strictest one required by the FDA. This label is used when there is evidence of a serious risk, such as blood clotting, associated with a drug. The FDA announcement comes after review of a clinical trial for rheumatoid arthritis patients using different doses of Xeljanz.
The Xeljanz 10-milligram twice daily dose is not approved for patients with psoriatic arthritis or rheumatoid arthritis. Pfizer, the maker of Xeljanz, has also said this dose of the drug is not recommended for such conditions.
This announcement follows a similar May 2019 warning by European regulators concerning the twice daily 10-milligram dosage. The European Medicines Agency concluded that certain patients are at serious risk of developing blood clots in their lungs. These are patients who:
- have had heart failure or cancer
- have a history of blood clots or clotting disorders
- are taking combined hormonal contraceptives or undergoing hormone replacement therapy
Xeljanz is a drug with a long and troubled history. It was first approved for sale in the United States by the FDA in 2012. Signs of adverse patient reactions soon developed. A required post-marketing safety study indicated that high doses of the drug caused serious side effects. The FDA advised 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.
Patients who take Xeljanz are at risk for pulmonary embolism and deep vein thrombosis. Symptoms of pulmonary embolism include:
- Sudden difficulty breathing
- Shortness of breath
- Chest pain
- Back pain
- Clammy or bluish skin
- Coughing up blood
- Severe sweating
Meanwhile, patients who develop deep vein thrombosis may show the following symptoms:
- Discoloration in the affected leg
- Swelling in the affected leg
- Pain in the leg that resembles a cramp
- Warmth in the affected area
The FDA’s announcement for a new warning label for Xeljanz is one of the clearest confirmations yet of the dangers of Xeljanz. If you have used the drug and developed pulmonary embolism or deep vein thrombosis, you should seek medical attention immediately. Take note of how your condition progresses as well as what treatments you are given.
Patients who have been harmed by Xeljanz may be entitled to financial compensation. This could include medical bills, lost wages, lost earning ability, and more. Drug injury attorneys continue to pursue these cases and ask for any patients hurt by Xeljanz to contact them.
One allegation that’s been raised against Pfizer is that the company failed to warn patients about the risks of Xeljanz. Another is that Pfizer conducted poor research into the drug’s side effects. Still another is failure to issue safety recalls. Various lawsuits have made these and other charges against the drug maker concerning Xeljanz. Talk to an attorney about what specific allegations you may be able to raise in your claim for relief.
An Attorney May Be Able to Help You Pursue Damages Over Xeljanz
Patients expect that the medicines they are prescribed will be reasonably safe. Every drug has side effects and carries some health risks. But with Xeljanz, there is evidence that Pfizer acted irresponsibly and to the severe detriment of its patients. If you are a victim of any unsafe medications, you should secure legal representation to fight for compensation. Contact an experienced attorney today to discuss your case and examine your options.