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Health hazard: Several deaths due to known arthritis drug

Health hazard: Several deaths due to known arthritis drug


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Arthritis drug: Increased risk of pulmonary embolism and death

Experts advise doctors and patients not to exceed the recommended dose of a particular rheumatoid arthritis medication. One study had shown that a higher dose increased the risk of pulmonary embolism and death.

Painful joint inflammation

According to health experts, around 800,000 people, mostly women, suffer from rheumatoid arthritis in Germany. Persistent inflammation damages the joints and bones. There is movement restriction and pain. The disease is not curable, but various medicines are available to relieve the symptoms. One of them is Xeljanz® (active ingredient: tofacitinib). This must not be dosed too high, otherwise the risk of pulmonary embolism and death increases.

Do not exceed the recommended dose

In coordination with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), the pharmaceutical company Pfizer calls on prescribing doctors not to exceed the recommended dose of Xeljanz® (active ingredient: tofacitinib) in the treatment of rheumatoid arthritis.

According to a risk information from the BfArM, this reference is based on early results from an ongoing study in patients with rheumatoid arthritis who showed an increased risk of blood clots in the lungs and deaths when the normal dose of 5 mg was doubled twice a day.

According to the experts, five milligrams twice a day are the EU-approved dose for rheumatoid arthritis (a disease that causes inflammation of the joints) and psoriatric arthritis (red, scaly skin areas with inflammation of the joints).

The higher dose of 10 mg twice a day is approved to initiate therapy in patients with ulcerative colitis (a disease that causes inflammation and ulcers in the intestinal lining).

As the BfArM explains in a recent communication, the dose of 10 mg tofacitinib twice a day is not approved for the use of rheumatoid arthritis in the EU.

Important information

The BfArM lists some important information for patients:

  • A new ongoing study in rheumatoid arthritis patients showed that when Xeljanz® is given at a high dose of ten milligrams twice a day, there is an increased risk of 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 medication without consulting your doctor.
  • If you experience any of the following symptoms, which may be signs of a blood clot in the lungs, you should see a doctor straight away: difficulty breathing, chest pain or upper back pain, coughing up blood, excessive sweating and bluish skin.
  • If you have any concerns about your medicine, you should discuss them with a doctor.

All healthcare professionals who are likely to prescribe the drug 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)

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