Some users of the rheumatoid arthritis drug Actemra are taking legal action against the drug’s manufacturer after their use of it led to cardiovascular incidents. The drug has been linked to reports of stroke, heart attack, and heart failure, as well as incidences of acute pancreatitis and interstitial lung disease.
There are concerns that the potentially life threatening side effects linked to Actemra were not disclosed by the drug’s maker or included on the drug’s packaging despite the manufacturer knowing there was a problem. Investigations are underway to determine if Roche and Genentech, the makers of Actemra, knew of the risks and failed to disclose them to the medical community and the public.
Tocilizumab, which goes by the brand name Actemra, is a drug used to treat rheumatoid arthritis. It is an immunosuppressive medication given via infusion or injection that was introduced in 2010. It was the first of the class of drugs known as IL-6 receptor inhibitors to become available.
In 2017, the FDA approved Actemra to also be used to treat giant cell arthritis. Additionally, the drug is used for a variety of off-label purposes.
Other drugs used to treat arthritis include strong warnings on their labels regarding their side effects but Actemra does not. This led doctors and patients to assume that Actemra did not have the same risks as other arthritis drugs, when that was not the case at all. Some recent reports suggest that Actemra is actually more dangerous and use of it carries with it a higher risk than alternative arthritis drugs.
According to a 2017 report from Statnews, thousands of people have filed adverse event reports concerning Actemra since it hit the market in 2010. Many of these reports included serious complications, such as heart attacks, heart failure, strokes, and other issues. More than 1100 deaths have been linked to Actemra use.
Two additional studies published that same year linked Actemra to an increased risk for infection. And a study published in 2018 linked Actemra to an increased risk for blood loss when used after knee replacement surgery.
Is Actemra Safe?
Actemra is used by many people and often considered a safer arthritis drug option because doctors and patients are unaware of the potential complications. It is believed that the manufacturers of the drug hid potential risks from the public and failed to include warnings on the drug’s label regarding the side effects.
Though some people have used Actemra without incident, many consider the drug dangerous. Side effects linked to the drug are extremely serious and more than a thousand deaths have been linked to use of the drug.
Potential Risk of Liver Damage
In addition to concerns about Actemra’s effect on cardiovascular and lung health, Canadian medical officials and Health Canada are currently assessing the potential risk for liver damage for users of Actemra.
The Canadian Health Department issued an official safety communication after reports of serious Actemra-induced liver injury (DILI) arose. Some Actemra users experienced acute liver failure requiring a transplant following use of the drug.
Health Canada has alerted doctors not to:
- Recommend Actemra to patients with active hepatic disease or hepatic impairment
- Initiate prescribe Actemra to patients with elevated blood liver enzyme of a certain level
Doctors have also been encouraged to discontinue use of Actemra in patients with significantly elevated blood liver enzymes and to monitor liver function on an ongoing basis in patients taking Actemra. Health Canada is working with the drug’s manufacturer to include a warning label on Actemra packaging in the future.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.