An independent research group called STAT analyzed a half million adverse reports from patients using the Rheumatoid Arthritis (RA) drugs. They uncovered that over 1,000 people who used Actemra died from heart attacks, stroke, and lung complications. Other RA medications warn of these side effects, but Actemra does not.
Actemra & Heart Attacks
Just six years after approval, the FDA received nearly 14,000 side-effect reports involving Actemra. Some also implicated that Actemra was responsible for over 1,000 deaths. STAT found that out of those who died, hundreds were from a condition not on the label – heart attack. Heart attacks bring a 50% risk of death. Users of Actemra were 1.5 times more likely to have a heart attack.
History of Heart Attacks
The FDA has investigated Actemra several times since it was approved in 2010. In a 2012 review, the organization found out of 118 deaths, half were from a heart attack or cardiac arrest. Yet, the FDA did not issue any warnings. The only warning on Actemra’s label is about possible serious infections.
In fact, the complaints to the FDA over the years indicate that not only does manufacturer Roche fail to provide adequate warning labels, but also the drug may actually cause more adverse events than other drugs on the market. Moreover, those other drugs actually have accurate warning labels.
Actemra & Stroke
Stroke is a disease that affects the arteries leading to and within the brain. It is the fifth leading cause of death in the US. eHealthMe, an online adverse report agency, studied almost 15,000 FDA adverse reports from people taking Actemra. They found that many experienced strokes after using Actemra. Stroke was especially high in females aged 60 or older and who took the drug for 6-12 months.
Lack of Stroke Warning
Actema is supposed to be competition for other drugs on the market such as Humira, Remicade and Enbrel. These other drugs carry warnings about stroke, but Actemra does not. Not having a warning may suggest it has a lower risk, but in a comparative study, Actemra brings a 1.5-times higher risk of stroke.
New studies confirm those with RA are at greater risk of stroke than others. The chronic inflammation was seen in RA escalates that risk. Researchers for years have uncovered this, yet the FDA still hasn’t added any warnings to the label.
In fact, the FDA has received thousands of complaints to the FDA over the years indicating heart failure is a side effect of Actemra. Yet, they haven’t demanded manufacturer Roche to provide adequate warning labels like similar drugs on the market.
The FDA should monitor the safety of prescription medications. However, it doesn’t verify the adverse event reports it receives. If they did, they would have known to immediately consider warnings for stroke. New research has shown that the rate of stroke is increasing every year. In 2010, there were only a handful of cases. Last year, that number quadrupled. If the FDA examined each report, they would have ensured the warning label mentions stroke like other drugs on the market. Without the warning, patients are misled to thinking that Acterma is safer. It is not.
Actemra & Interstitial Lung Disease (ILD)
Interstitial lung disease (ILD) is a condition where the tissue in the lungs becomes inflamed and scarred. When the lungs are inflamed, it can lead to shortness of breath and coughing. This can become very severe. Unfortunately, ILD is common for those with RA. Researchers do not know why.
Recently, evidence suggests drugs like Acterma may make the condition worse. Serious cases of ILD have also been reported in RA patients receiving treatment with anti-tumor necrosis factor (TNF) drugs or tocilizumab. However, evidence to this effect is mixed. The risk factors of ILD in patients with RA have not been fully studied.
Failure to Warn about ILD
Many of the RA drugs on the market bring the same risks of ILD. The difference is the other drugs warn about ILD and Acterma does not. The FDA should monitor the safety of prescription medications. However, it doesn’t verify the adverse event reports it receives. If they did, they would have known to immediately consider warnings for ILD. Almost 58% of people with RA are at risk for ILD, but without the warnings, they don’t know it.
Not having a warning makes one medication seem safer than the other which has it.
We Want to Help Victims
It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one has developed pancreatitis and have taken Acterma, you should demand accountability. Why didn’t Roche tell you of these serious side effects?
We want to help send a message that this is not acceptable. If a dangerous product harmed you, we will be your advocate. Additionally, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.