Actemra is a drug used to treat rheumatoid arthritis, which affects 1.5 million Americans. It can be taken via injection or intravenously. With 760,000 patients worldwide, one would expect the drug to be safe; however, post-clinical studies have found that Actemra can lead to the following noxious side effects:
- Heart attack
- Heart failure
- Lung Complications
Actemra is a product of Roche Holding AG and its subsidiary Genentech. They made $1.6 billion off of Actemra in 2016.
The side effects in and of themselves are not usual for an arthritis drug such as this, although some appear at a higher rate. What is alarming is that none of these side effects are listed on the drug’s warning label.
Actemra was approved for general use in 2010, but as reported by STAT, the long-term repercussions of use were not properly studied. These lethal issues came into the public eye in a variety of ways. In one instance, 13,500 cases of the aforementioned effects were reported to Advera Health Analytics through their online initiative, the FDA Adverse Effects Reporting System (FAERS). This is meant to track developments that were not discovered during clinical trials. It found that Actemra patients suffered similar side effects than those taking Humira and other arteritis medications, but many of those were not currently on the drug’s label.
That being said, Actemra may cause cardiovascular disease more than its competitors, as shown by recent studies, but still does not warn patients at all about such potential risk. Similarly, the rare disease, Pancreatitis, or inflation of the pancreas, appeared in many Actemra patients due to the drug increasing the user’s lipid count, according to post-clinical studies.
Despite the newly discovered facts, the FDA is having a hard time getting the warnings added to the label. This is because they require more evidence than is presented in these studies.
The story of Actemra is analogous to another arteritis drug, Vioxx, which was pulled from the market. Both of the drugs had long-term side effects that were not properly studied during trials and ended with many people getting hurt from those they did not know even existed. Other arteritis drugs have had their effects extensively studied, like Humira, and they appear on its label.
It is important to note that these known cases were either reported to the FDA or an outside source, like FAERS. There are likely many more, different complications that have never been reported, and the ones mentioned may occur at greater rates.