If You Take This Popular Medication, Talk to Your Doctor Now, FDA Says
A clinical trial found it could lead to "serious heart-related events, cancer, blood clots, and death."
People rely on medications to help address everything from alleviating pain to keeping serious medical conditions under control. But every so often, new information comes to light that may force us to reconsider the pills we take. Now, the U.S. Food & Drug Administration (FDA) is urging anyone taking one popular medication in particular to speak to their doctor immediately. Read on to see if anything in your medicine cabinet is putting you in danger.
The FDA has ordered a change in safety warnings for the popular medication Xeljanz and Xeljanz XR.
According to an announcement on Sept. 1, the FDA is requiring a change to the Boxed Warning for Xeljanz and Xeljanz XR. The popular medications—generically known as tofacitinib—are used to treat arthritis and ulcerative colitis.
The agency says the update comes as the result of a large randomized clinical safety trial that found the drug increased the risk of serious health issues such as heart attack, stroke, cancer, blood clots, and death when compared with another type of arthritis medicine known as tumor necrosis factor (TNF) blockers. Specifically, the FDA reports that the trial found an increased risk of blood clots and death in patients who took a lower dose of Xeljanz.
Two other related arthritis drugs are also affected by the safety warning update.
The FDA specified that the new warnings also extend to two other arthritis medications, Olumiant and Rinvoq, known generically as baricitinib and upadacitinib, respectively. The two pills come from the same drug class as Xeljanz, known as Janus kinase (JAK) inhibitors.
"Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated," the agency wrote in their statement. "However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial."
Current or past smokers who take Xeljanz are at an especially high risk of health issues.
According to the FDA, anyone who is a current or past smoker and is taking Xeljanz, Xeljanz XR, Olumiant, or Rinvoq should speak to their doctor right away since the habit can put them at higher risk for potentially serious health issues. In addition, they warn that patients with a history of heart attack, heart problems, stroke, or blood clots should also call their doctors immediately to discuss potential risk factors associated with taking the medications.
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The FDA says you should seek medical attention immediately if you notice symptoms of a heart attack or stroke.
The FDA urges anyone taking Xeljanz or the listed medications to immediately seek emergency medical assistance if they notice the symptoms of a heart attack, stroke, or blood clot. According to the agency, this includes discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back; severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw; unusual pain or discomfort in your arms, back, neck, jaw, or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; slurred speech; drooping on one side of the face or mouth; swelling of a leg or arm; and leg pain, tenderness, or red or discolored skin in the painful or swollen leg or arm.
The agency also advises that the medications have been linked to an increased risk of certain cancers such as lymphoma and lung cancer. They suggest talking to your doctor if you notice symptoms such as swelling of lymph nodes in your neck, armpits, or groin; constantly feeling tired; fever; night sweats; persistent or worsening cough; difficulty breathing; hoarseness or wheezing; or unexplained weight loss.