“Black Box Warning” For Xeljanz 10 mg Twice Daily Dose Required By FDA In July 2019 Follows Regulatory Action In Europe

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

A Xeljanz FDA Drug Safety Communication issued July 26, 2019 announced the addition of a so-called “Black Box Warning” about an increased risk of blood clots and death with the 10 mg twice daily dose of Xeljanz used by ulcerative colitis patients. 

From the Safety Announcement part of that document, “FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)“, we get the following:

The U.S. Food and Drug Administration has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis. In addition, the approved use of [Xeljanz] for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines. We approved these changes, including adding our most prominent Boxed Warning, after reviewing interim data from an ongoing safety clinical trial of [Xeljanz] in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medicine.

The 10 mg twice daily dose of [Xeljanz] is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking [Xeljanz] for ulcerative colitis.

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Besides this Xeljanz Boxed Warning mandated by FDA in July 2019, two new parts were added to the WARNINGS AND PRECAUTIONS section of the Xeljanz drug label (“Revised: 07/2019” version):

5.2 Mortality
Rheumatoid arthritis patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study.

A dosage of XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA [see Dosage and Administration (2.2)].

For the treatment of UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response [see Dosage and Administration (2.3)].

5.4 Thrombosis
Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, was observed at an increased incidence in patients with rheumatoid arthritis 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing study. Many of these events were serious and some resulted in death [see Warnings and Precautions (5.2)].

A dosage of XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA [see Dosage and Administration (2.2)].

In a long-term extension study in patients with UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer.

Promptly evaluate patients with symptoms of thrombosis and discontinue XELJANZ/XELJANZ XR in patients with symptoms of thrombosis.

Avoid XELJANZ/XELJANZ XR in patients that may be at increased risk of thrombosis. For the treatment of UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response [see Dosage and Administration (2.3)].

For some background on Xeljanz drug safety issues prior to this July 2019 FDA Drug Safety Communication including earlier drug regulatory agency actions in Europe, we refer you to our June 4, 2019 article “Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible“.

We will continue to monitor developments with respect to the drug safety profile of Xeljanz in the US and Europe.

Our law firm is investigating possible Xeljanz lawsuits against the pharmaceutical company Pfizer as personal injury cases or wrongful death claims, depending on the outcome for a patient who suffered Xeljanz side effects.


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