Actemra, a popular prescription drug used to treat rheumatoid arthritis, has recently been linked to a large amount of serious, deadly side effects including heart failure and strokes. If you or a loved one has taken Actemra for rheumatoid arthritis or any other afflictions, you may be entitled to compensation from the manufacturers. Contact us today to discuss your case!
What is Rheumatoid Arthritis?
Rheumatoid arthritis is an autoimmune disorder that causes pain, stiffness, and swelling in joints. Although it primarily affects joints, rheumatoid arthritis (RA) is a disease that can also cause inflammation in other parts of the body, including lungs and heart.
Although RA shares some of the same symptoms as the more common osteoarthritis, it’s considerably more severe. Osteoarthritis is a degenerative disorder that primarily comes about to old age, while RA is an autoimmune disorder where the body’s immune system effectively attacks the joints, resulting in inflammation and thickening of the joint capsule.
Additionally, while osteoarthritis affects people in old age, RA commonly develops in middle age, and can even affect children and young adults. This crippling disease affects about 1.5 million Americans, and significantly impacts a person’s quality of life.
What is Actemra?
Actemra is a drug used to treat the symptoms of rheumatoid arthritis. Manufactured by Roche/Genentech, Actemra was first approved for use as treatment for RA by the U.S Food & Drug Administration (FDA) in January 2010. It is administered via injection or intravenously, and has been taken by roughly 760,000 patients so far.
When it was introduced in 2010, Actemra was advertised as a breakthrough drug, deemed a safer alternative to other, similar treatments for RA. This is mainly due to its perceived lack of severe side effects – most RA drugs notify users that they may be associated with a higher risk of heart attacks, heart failure, or serious lung complications.
The Dangers of Actemra
In June 2017, STAT news found that the claims of minimal side effects by manufacturers Roche and Genentech were grossly inaccurate. They held a comprehensive analysis of over 500,000 side-effect reports on Actemra patients, and the results were shocking. STAT found that the risks of heart attacks, strokes, and other serious life-threatening conditions in Actemra patients were high, similar to those of competing drugs.
Side Effects of Actemra
Common side effects of Actemra include:
- Runny/stuffy nose
- Sinus pain
- Sore throat
- Mild stomach cramps
- Urinary tract infection (UTI)
Patient blood test data has shown that those who take Actemra had elevated levels of cholesterol and triglycerides in their blood, lipid compounds that may cause serious heart problems over time – and may be the cause of severe, undisclosed side effects, including:
- Heart attack
- Heart failure
- Interstitial lung disease
- Hair loss
If you or your loved ones have experienced any of the above side effects, we can help.
Actemra is a “Failure to Warn” Case
While Actemra’s side effects are extremely serious, all of its competitors have similar side effects. The only difference is that the competing drugs explicitly warn patients of their potential side effects on their labels. Actemra does not warn patients of the side effects, nor does it address any of them in any documentation.
This is a clear case of “failure to warn,” a law which states that companies must provide adequate warnings for a product, especially if the consumer is at risk of injury or death. Roche/Genentech, the manufacturers, can be held liable for misleading consumers about the drug’s potentially fatal side effects – and we can help you get justice for being wrongfully notified.
Actemra – A Closer Look at the Numbers
The data since Actemra was released is eye-opening:
- 1,128 people have died after taking Actemra.
- In an initial study, pancreatitis was reported in 132 patients taking Actemra – 26 ultimately died. Pancreatitis is an extremely rare disorder that, in its acute form, can kill up to 50% of all patients.
- A study by the FDA found that rates of stroke and heart failure were roughly 1.5 times higher in Actemra than in a competing arthritis drug, Enbrel.
- In 2012, an FDA review of clinical trials and historical data found 258 cases of pancreatitis and 185 cases of interstitial lung disease.
- Actemra generated $1.7 billion in sales last year. That makes it Roche’s fifth highest-grossing drug.
Most troubling is the thought that deaths among Actemra users may actually be higher because doctors and patients aren’t obligated to report their afflictions to the FDA. Experts estimated that the official filings may represent only 10 percent of all cases.
The State of Actemra Today
Despite the disturbing statistics, Actemra is still being used currently to treat rheumatoid arthritis, and Roche/Genentech is looking for other avenues for the drug. In May, the FDA approved Acemtra to treat giant cell arteritis, a similar autoimmune disease that results in inflammation of blood vessels. It was based on a one-year study held by Genentech with only 149 participants.
Additionally, doctors are routinely giving Actemra as an “off-label” drug – prescribing it to patients for roughly 60 other conditions that have not been approved for safety and efficacy.
Affected by Actemra? We Can Help!
At Estey & Bomberger we have a wide breadth of experience in personal injury, wrongful death, and pharmaceutical litigation. We have the knowhow and resources to understand all the law surrounding dangerous pharmaceutical drugs – and the rights that consumers have when things go wrong.
Actemra may be a serious prescription drug that can result in severe side effects that could dramatically change your quality of life. If you’ve taken Actemra and suffered from side effects, contact us for a free case evaluation. Our pharmaceutical lawyers are here to fight for your safety and health, and give you the compensation you deserve.