The JAK inhibitor Xeljianz by manufacturer Pfizer has recently received several warnings from U.S. and international government regulators due to blood clot issues. This medication is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in its 10-mg twice a day dosage to treat patients with ulcerative colitis. The 5-mg twice a day dosage is approved to treat colitis, rheumatoid arthritis and psoriatic arthritis.
Warnings About Xeljianz
The EMA had previously imposed a temporary restriction on the drug. At the time, the EMA safety committee instructed doctors not to prescribe the drug to patients at risk of blood clots. However, it recently increased this warning to a formal one, stating that the drug should not be used in patients with ulcerative colitis who are at a high risk of blood clots unless there is no other viable alternative, a step back from the temporary warning. However, the final warning issued by the EMA recommends that the drug be used with caution for all patients at high risk of blood clots and not be used in patients older than 65 due to a heightened risk of infections if there is an available alternative. Patients at increased risk include those who have had a heart attack, heart failure, a history of blood clots or other medical disorders. The warning applies to any dosage of the drug.
Regulators issued the warning after the Committee for Medicinal Products for Human Use, the EMA’s drug review body, endorsed it. After the European Commission agrees, it will become official.
The FDA issued a boxed warning for the product, advising against the use of the 10-mg dosage both for patients who were receiving it as a starting dose or who were receiving it as a maintenance dose.
Reason for Warnings
A post-marketing study in patients with rheumatoid arthritis was completed after the drug was released to the market. The patients were 50 years of age or older who had at least one priori cardiovascular risk factor. In this study, there were alarming cardiovascular signals of some of the patients. Some of the patients who were receiving the 10-mg twice a day dosage had an increased risk of blood clots in the veins of their legs and in their lungs. The manufacturer took these patients off the study.
Officials from the EMA reported that even patients who took the lower dosage had increased risk factors, such as an increased risk of pulmonary embolism that exceeded the risk involved with using other inhibitors.
Help for Injured Patients
Patients who take the inhibitor should talk to their doctor about the risks of continuing to take the medication versus discontinuing the dosage. They should be informed of other alternatives and the risks associated with them.
Individuals who are harmed by dangerous drugs may be able to pursue compensation against the manufacturer of these drugs. Even if a regulatory authority like the FDA initially approves a drug, problems associated with the drug may not be discovered until patients take the medication for a prolonged period of time or patients with certain medical conditions or who take other medications are negatively affected by the drug. An experienced dangerous drug lawyer can discuss your claim during a confidential consultation.
