Arthritis Medication Xeljanz Linked To Risk Of Heart Attack And Cancer – Healthcare


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Pfizer’s Xeljanz and Xeljanz XR (tofacitinib), a popular
drug used to treat rheumatoid arthritis, psoriatic arthritis, and
ulcerative colitis, has been linked to an increased risk of serious
heart problems, cancer, and death, especially in older patients
– the largest demographic among Xeljanz users.

A large clinical trial showed a higher rate of serious
heart-related events, such as heart attack and stroke, and cancers,
including lung cancer and lymphomas, in people treated with Xeljanz
compared to an alternative treatment. The FDA and Health Canada
have confirmed the findings of the trial and are warning the public
of the increased risk of these dangerous side

Xeljanz is an oral medication prescribed for rheumatoid
arthritis and ulcerative colitis

Xeljanz is a drug used to treat serious, chronic, and
progressive inflammatory conditions, namely rheumatoid arthritis,
psoriatic arthritis, and ulcerative colitis. Rheumatoid arthritis
(RA) is a condition in which the body attacks its own joints,
causing pain, swelling, joint damage, and loss of function.
Psoriatic arthritis is a type of arthritis linked to psoriasis that
causes similar symptoms. Ulcerative colitis is a chronic,
inflammatory disease affecting the colon. As the incidence of RA
increases with age (over 3% of Canadians aged 70-79 and over 4% of
Canadians aged 80+), Xeljanz users tend to be older patients.

Xeljanz is in the class of medications known as janus
kinase (JAK) inhibitors, which function by slowing the
activity of enzymes that transmit information into the cell
nucleus, influencing the immune response. By interfering with the
enzymes, Xeljanz decreases the activity of the immune
system, inhibiting the production of inflammatory mediators,
and suppressing certain genes in joint tissue. This is meant
to provide therapeutic benefits for patients suffering

Xeljanz has been marketed in Canada since 2014. It is also
available as an extended-release tablet (Xeljanz XR). Xeljanz was
the first oral medication approved to treat rheumatoid arthritis
that was a different class of drug than the standard treatment for
RA, methotrexate – a drug which a high percentage of patients
have a poor response to. With the Canadian population aging and
Xeljanz being easy to administer, Xeljanz’s popularity has
increased over time, with over 65,000 prescriptions filled in
Canadian pharmacies in 2020.

A large clinical trial has linked Xeljanz to major adverse
cardiovascular events and cancers

When US Food and Drug Administration (FDA) first approved
tofacitinib in 2012, it required Pfizer to conduct a clinical trial
to evaluate the risk of heart-related events, cancer, and other
side effects.

The trial was a massive, randomized study of over 4300 patients
split into three groups: ones taking a low dose of tofacitinib,
ones taking a high dose, and ones taking an alternative treatment.
Patients were required to be at least 50 years old and have at
least one risk factor for heart disease.

The full results of the trial were finally
published earlier this year, and the researchers concluded that
Xeljanz poses an increased risk of major adverse cardiovascular
events (MACE) and cancers. Notable findings included:

  • the rate of serious heart-related events (such as heart attack
    and stroke), cancer, blood clots, and death was higher in both
    groups of patients treated with Xeljanz;

  • a higher rate of lymphomas was specifically observed in
    patients treated with Xeljanz;

  • a higher rate of lung cancers was also observed in smokers
    treated with Xeljanz; and

  • current or past smokers also had an additional increased risk
    of overall cancers.

On September 1, 2021, based on its own review of trial results,
the FDA announced that it had independently concluded there is an
increased risk of serious heart-related events, such as heart
attack or stroke, cancer, blood clots, and death with Xeljanz. On
January 12, 2022, Health Canada followed suit and announced that it
was also confirming a link between Xeljanz and increased risks of
serious heart-related problems and cancer, especially in older
patients, patients who are current or past smokers, and patients
with cardiovascular or cancer risk factors.

Pfizer’s updated label warns of serious cardiovascular
events and cancer

Pfizer’s post-market clinical trial had been ongoing since
2012. However, until very recently, the Canadian product monograph
did not provide substantial warnings for patients and doctors of
the increased risk of serious heart-related events (such as heart
attack or stroke), cancer, blood clots, and death with Xeljanz.

Following their safety review of the final trial results, Health
Canada required Pfizer to update the product labels to further
strengthen the warnings on the elevated risks of cancer and heart

In December 2021, Pfizer Canada ULC (a subsidiary of
multinational pharmaceutical manufacturer Pfizer Inc.)
significantly revised the Health Canada Product Monograph, which is
intended to provide information about the properties, claims,
indications, and conditions of use of the drug, with new warnings
about links to serious heart issues and cancer, including:

  • a warning for major adverse cardiovascular events was added to
    the monograph;

  • new warnings concerning cancers were also added, including
    specifically detailed warnings addressing increased observations of
    lung cancers and lymphomas;

  • heart attacks and multiple types of cancers were added among
    the table outlining all potential serious side effects for
    patients; and

  • additional cautions were also added for older patients, current
    or past smokers, and patients with cardiovascular or cancer risk

In May 2022, Pfizer introduced further warnings to the
Monograph, including:

  • a warning that bone fractures of multiple types, including
    osteoporotic fractures, had been observed; and

  • warnings that a dosage of Xeljanz 10mg twice a day was not
    recommended for the treatment of rheumatoid arthritis or psoriatic

Xeljanz and Xeljanz XR (tofacitinib) class action

Siskinds LLP and Siskinds’ Québec-based affiliate,
Siskinds, Desmeules, are seeking to recover compensation for
Canadians who suffer injuries resulting from their use of
prescription Xeljanz. 
Siskinds Desmeules has filed a class action
 alleging that
the makers of Xeljanz failed to adequately warn users of Xeljanz,
and their health care providers, that Xeljanz increases the risk of
major adverse cardiovascular events, including death, heart attack,
coronary revascularization, stroke, hospitalization for heart
failure, and cancer.

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