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Xeljanz (tofacitinib) Study Triggers FDA Safety Announcement

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DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.

Xeljanz (tofacitinib) was approved by the FDA to treat adults suffering from:

  • moderate to severe active rheumatoid arthritis (RA)
  • moderate to severe ulcerative colitis
  • active psoriatic arthritis

Xeljanz was developed to help adults who have an inadequate response to or are intolerant of methotrexate, one of the most widely-used medications for arthritis.

Unfortunately, a recent safety trial has found an increased risk of severe side effects, including blood clots, in patients who take a high dosage of Xeljanz for RA. The safety trial is ongoing and should be completed by the end of 2019.

Who Makes Xeljanz?

New York

Xeljanz is manufactured and marketed by Pfizer Inc., one of the world’s largest pharmecuetical companies. It was opened in 1849 and was the first domestic producer of cream of tartar. Pfizer owns many popular brands and drugs like Advil, ChapStick, Viagra, and Lipitor.

There is no generic version of Xeljanz on the market. Without insurance, the drug costs around $4,444 a month.

FDA Approval of Xeljanz

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In 2012, the U.S. Food and Drug Administration (FDA) approved Xeljanz in doses of 5 mg twice-daily doses for the treatment of rheumatoid arthritis. In May 2018, the FDA approved Xeljanz in 10 mg twice-daily dosage for the treatment of ulcerative colitis.

As part of their original approval, the FDA required a postmarketing trial to test the effectiveness of the high 10 mg dose in RA patients. Trial patients were required to be at least 50 years old and to have at least one cardiovascular risk factor.

In February 2019, the FDA found that patients treated with 10 mg twice daily had an increased occurrence of blood clots and death compared to patients who only took 5 mg twice daily. The FDA released a safety warning and Pfizer immediately put the patients involved in the study back on the 5 mg dosage.

What Are the Side Effects of Xeljanz?

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Common side effects of the 5 mg twice-daily dose include:

  • Upper respiratory tract infections
  • Headache
  • Diarrhea
  • Nasopharyngitis (inflammation of the nasal passages and throat)

Adults taking 10 mg twice-daily doses for RA may be at an increased risk for blood clots in the lungs (pulmonary embolism). Seek medical attention immediately if you experience any of these blood clot symptoms while taking Xeljanz:

  • Clammy or bluish skin
  • Excessive sweating
  • Chest or back pain
  • Coughing up blood
  • Sudden shortness of breath
  • Difficulty breathing

Has Pfizer Warned Patients of Potential Side Effects?

Pfizer has made the side effects and warnings available on the label and on the medication website.

What Should I Do If My Loved One Is Suffering From Severe Side Effects from Xeljanz?

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If you or a loved one is suffering an adverse event from taking Xeljanz, seek medical attention immediately. Do not stop taking an FDA-approved drug without first consulting your doctor. Hensley Legal Group does not recommend that you cease taking any FDA-approved drug without first consulting a licensed medical professional.

If you or a loved one has suffered an adverse side effect from Xeljanz, you may be eligible for compensation. A personal injury attorney can take a look at your case and help you determine what your options are. Call Hensley Legal Group today for a free conversation about your claim, or contact us online.