In 2010, Actemra was released onto the market as an option for patients with rheumatoid arthritis. Initially, it was believed that Actemra would offer relief to patients while helping them avoid side effects commonly seen in other immunosuppressive medications. Actemra was the first drug on the market to block IL-6, a protein that causes inflammation in the body. Despite its initial promise, more than 1,000 deaths have been reported with the use of this drug.
Increase in Deadly Side Effects
Sadly, more than 500,000 adverse events related to Actemra have been filed with the FDA. This includes the more than 1,000 deaths. Reported adverse events include heart attacks, strokes, and heart failure. Although there are risks with the use of any immunosuppressant for rheumatoid arthritis, Actemra advertised their medication on the premise that those risks didn’t exist with their medication. In addition to those serious and potentially deadly side effects, Actemra was reported linked to the development of pancreatitis. Pancreatitis is fatal around 50% of the time.
Was Actemra’s Manufacturer Negligent in Its Warnings?
Currently, there is a focus on Actemra’s serious side effects and the lack of warnings given by its manufacturers, Roche and Genentech. An article from STAT that highlights the serious and deadly side effects of the drug quotes Dr. Vinay Prasad who points to the fact that the potential dangers may not exist solely because of the manufacturers. “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective.”
Roche asked the FDA in 2012 to approve wider use of their drug in certain cases of rheumatoid arthritis. However, during the review period, it was found that 258 cases of pancreatitis occurred during clinical trials. Additionally, 185 patients developed interstitial lung disease. Despite these results and the recommendation of an expert to include a warning label for the drug, no warning label was created for use.
Symptoms of Pancreatitis
If you or someone you love currently takes Actemra, it’s important to recognize the symptoms of pancreatitis. Pancreatitis is an inflammation of the pancreas and is a medical emergency. It can last for a few days or it can become life-threatening. Symptoms include:
- Upper abdominal pain
- Abdominal pain that goes into your back
- Abdominal pain that gets worse after eating
- Fever
- Nausea or vomiting
- Tender abdomen
- Increased heart rate
- Weight loss
- Oily stools
Pancreatitis can result in serious conditions including a pseudocyst that causes internal bleeding, breathing problems, kidney failure, diabetes, malnutrition, and it increases your risk of developing pancreatic cancer.
Goldwater Law Firm – Helping Injured Patients Get What They Deserve
If you or someone you love takes Actemra and you’ve suffered a heart attack, stroke, developed pancreatitis, or had another serious side effect, contact Goldwater Law Firm right away. Our drug injury attorneys provide free case evaluations. We help injured patients get compensation for their injuries.