Medicines Agency warns: Arthritis drug increases the risk for blood clots
The drug Xeljanz, which is used to treat rheumatoid Arthritis, could increase in certain patients the risk of blood clots in the lungs, and deep veins. To comply with this judgment, the European medicines Agency (EMA) in a report.
Therefore, the Agency recommends that Xeljanz should be used with the active ingredient Tofacitinib with caution in these patients, informed now by the Federal Institute for drugs and medical devices (BfArM).
These patients have increased risk for blood clots
Specifically, patients who already have a high risk for blood clots.
The can according to the BfArM in patients be the case that a heart attack or blood clot or suffer heart failure, cancer, or a hereditary blood clotting disorder leiden.
"You can also at risk if you combined hormonal contraceptive or a hormone replacement therapy received a major surgery to undergo or have recently undergone, or move the", it is said by the health authority.
Also, these patients should not take Xeljanz
In addition, the EMA should, according to these patients taking Xeljanz only in absolute exceptional cases, i.e. when there is no other suitable drug:
- Patients with a chronic inflammation of the colon mucosa (ulcerative colitis), which is a high risk for blood clots in.
- Patients over 65, you is, therefore, an increased risk of infection
Therapy in rheumatoid Arthritis
The drug Xeljanz (active ingredient: Tofacitinib) is prescribed to patients with moderate to severe rheumatoid Arthritis. In the case of a rheumatoid Arthritis usually inflames multiple joints chronic.
The Federal Institute for drugs and medical products to the patients concerned advises:
- Very important: "If you are being treated with Xeljanz, you should not change the dose or stop taking the drug to quit without discussing it with your doctor."
- "If you are being treated with Xeljanz, your doctor will check your risk for blood clots and their treatment adjusted, if necessary."
- "If you have a high risk or are older than 65 years, your doctor may change your treatment, if there is an alternative treatment for you."
In the case of these complaints immediately to the doctor
Necessarily a doctor immediately patients taking Xeljanz, and a sudden shortness of breath or difficulty in breathing, chest pain, or pain in the upper back, swelling of the leg or arm, leg pain or tenderness, redness or discoloration in the leg or Arm suffering to seek medical advice. All these may be signs of a blood clot in the lungs or the veins be.
The current recommendations of the European medicines Agency are based on a study of data from patients with rheumatoid Arthritis and an increased risk for cardiovascular diseases were studied.
The Xeljanz revenue have been shown, the BfArM, the risk for the formation of blood clots in deep veins and lungs in patients was higher.
Increased risk for older patients
"In particular, this involved patients who were treated twice daily with 10 mg of revenue, or over a longer period of time."
In addition, the study concluded that in patients over 65 years, the risk for severe and fatal infections compared to younger patients was increased.
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