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Canadian health officials have launched a safety investigation which will look into the potential heart and cancer risks from Xeljanz, after preliminary data was released by Pfizer from a recently completed study involving the arthritis and ulcerative colitis drug.
Xeljanz (tofacitinib) is part of a new generation of drugs approved for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, which was first introduced by Pfizer in 2012. It joined a lucrative market, which already included long-standing treatment options like Humira, Enbrel and other similar medications, known as tumor necrosis factor (TNF) inhibitors, which generate billions in sales each year.
Amid aggressive marketing over the past eight years, Pfizer grew Xeljanz into a blockbuster medication, generating annual sales in excess of $2 billion worldwide, with more than 200,000 prescriptions worldwide. However, concerns have emerged in recent weeks about serious and potential life-threatening health risks associated with Xeljanz, including major heart problems and cancers diagnosed among users in a post-marketing study that was recently wrapped up.
In February, the FDA issued a safety communication about the potential side effects of Xeljanz identified from a preliminary review of the data, raising questions about whether the agency may require new warnings or a recall in the United States.
Health Canada issued a press release on April 6, indicating it is also conducting a safety review of both Xeljanz and Xeljanz XR, after a risk of serious heart-related issues and cancers were linked to both doses of the drug. The drug’s Canadian labels already carry cancer warnings and information on heart attacks with Xeljanz, but the agency is weighing what more it can do.
“The current Canadian label includes serious warnings and precautions for cancer and information on heart attacks, which were the most frequently reported serious heart-related problems in this trial,” the press release states. “Health Canada is working with Pfizer to evaluate the available safety information for Xeljanz and Xeljanz XR and will inform the public of any new safety findings, as needed, once the review is complete.”
The study behind the Health Canada and FDA concerns was initially launched in January 2012, and given the long latency period for many cancers, many users now face concerns that they require on-going medical monitoring to detect and diagnose cases in the future.
Although the drug maker disclosed that lung cancer on Xeljanz was the most frequently reported malignancy identified in the study, no information has been provided about other types of cancer identified, or potential signs and symptoms for which former users should be monitored. In addition, it remains unclear how the Xeljanz cancer cases were distributed in time and across different doses of the medication, as well as how long users were monitored.
While awaiting access to the full data, rheumatologists and other experts have raised serious concerns about how the medication should be prescribed and question whether the FDA will be required to further restrict user of the medication, or even potentially recommend a Xeljanz recall. However, health experts caution that users should not stop taking the medication without first consulting with their own healthcare provider.
Former users are now contacting lawyers who are investigating Xeljanz lawsuits and class action claims, to seek additional information which has not been disclosed and compensation for treatments they may now require.
Currently, Health Canada is recommending patients do not stop or change their Xeljanz dose without first consulting their health care professional. It also recommends health care professionals carefully consider the benefits and risks of Xeljanz when prescribing the medication to patients, follow the recommendations for the specific condition being treated, and report any health or safety concerns.