Health risk: more deaths due to well-known Arthritis drug

Medication for Arthritis: Increased risk of pulmonary embolism and death

Experts do not advise Doctors and patients to exceed the recommended dose of a particular drug for the treatment of rheumatoid Arthritis. A study had shown that a higher dose increases the risk of pulmonary embolism and death.

Painful Inflammation Of The Joints

According to health experts, about 800,000 people, predominantly women, suffer in Germany on rheumatoid Arthritis. A persistent damaging inflammation of the joints and the bones. It comes to restricted movement and pain. The disease is not curable, but there are various medicines available to relieve the discomfort. One of them is Xeljanz® (active ingredient: Tofacitinib). This should not be dosed to high, otherwise the risk for pulmonary embolism, and death increases.

Do not exceed recommended dosage

The pharmaceutical company Pfizer calls on prescribers, in consultation with the European medicines Agency (EMA) and the Federal Institute for drugs and medical devices (BfArM), not to exceed the recommended dose of Xeljanz® (active ingredient: Tofacitinib) for the treatment of rheumatoid Arthritis.

According to a risk information of the BfArM, this note on the early results of an ongoing study in patients with rheumatoid Arthritis showed an increased risk for blood clots in the lungs and death cases, when the normal dose of 5 mg twice doubled daily based.

According to the experts five milligrams twice daily in the EU approved dose for rheumatoid Arthritis (a disease causing inflammation of the joints) and the psoriatrische Arthritis (red, scaly areas of the skin with inflammation of the joints).

The higher dose of 10 mg twice per day is approved for initiation of therapy in patients with ulcerative colitis (a disease causing inflammation and ulcers in the intestinal lining causing).

As the BfArM in a recent message declared, is not approved for the dose of 10 mg of Tofacitinib twice daily in the EU for the application of rheumatoid Arthritis.

Important Information

The BfArM lists some important information for patients:

  • A new ongoing study in patients with rheumatoid Arthritis showed that administration of Xeljanz® in a high dose of ten milligrams twice a day have an increased risk for dangerous blood clots in the lungs and death.
  • This dose is higher than the approved dose of five milligrams twice a day for rheumatoid Arthritis.
  • If you are being treated with Xeljanz®, you should not change the dose or stop taking the drug set, without discussing it with your doctor.
  • In the case of the following symptoms can be signs of a blood clot in the lung, you should immediately consult a doctor: difficulty in breathing, chest pain, or pain in the upper back, cough up blood, excessive sweating and bluish skin.
  • If you have any concerns about your medicine, you should discuss this with a doctor.

All health professionals who prescribe the drug expected, will be informed in writing of the preliminary results of the study and the current treatment recommendations by means of a “Red Hand letter”. (ad)