July 7, 2017 — San Diego, CA. Once again we have to ask: did the FDA fail us in not taking action against maker Genentech, a wholly owned subsidiary of Roche, for not telling doctors and patients that Actemra could lead to heart failure?
When STAT News broke the story on this drug, the FDA had already received reports of 1,128 deaths from Actemra.
Is the FDA is trying to fast track these new drugs to the market. Is it pressure from Bug Pharma looking to increase its ever growing revenue? Or is the FDA so bloated as a bureaucracy that it simply can’t keep up?
Let’s look at what Actemra is
Actemra (Tocilizumab) was developed and marketed starting in 2010 by Genentech (Roche Inc.) it is an immunosuppressive drug and can be used to treat both moderate and severe rheumatoid arthritis.
It was later approved by the FDA in May 2017 for the additional use in treating Giant Cell Arteritis (GCA).
Method of administration is intravenous (in monthly injections). It’s estimated that close to one million people have used Actemra. Genentech has reported $1.7 billion in Actemra sales for 2016.
Rheumatoid arthritis is an inflammation in hands, wrists, and knee joints. This condition affects 1% of Americans. Physicians aren’t sure of the cause of this fairly common disease.
Most of the drugs used to treat rheumatoid arthritis are classified as NSAIDS (Nonsteroidal anti-inflammatory drugs). Most of these drugs carry warnings of heart attack and other heart risks on their labels, Actemra does not.
The FDA knew of Actemra deaths and adds a new approval
When STAT was looking at the data, it appeared that the rate of risks of heart attack and other side effects was as high as or even higher than other rheumatoid arthritis drugs. So again we ask: Is the FDA doing enough long term studies on this and other drugs? What about post market studies, were they done for Actemra?
Even when faced with a mountain of data, on May 22, 2017 the FDA grants and expands approved use of subcutaneous Actemra (tocilizumab) to treat adults with Giant Cell Arteritis.
Badrul Chowdhury, M.D., Ph.D., and director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research states: “We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had limited treatment options.”
Is there an Actemra lawsuit?
The basis of this Actemra lawsuit is fairly simple: Genentech, a wholly owned subsidiary of Roche, failed to warn both doctors and users of the potential side effects including lung disease, increased stoke risks, myocardial infarction (heart attack), heart failure, and even death in some patients.
We intend to fully hold Genentech, a Roche company responsible for not warning both the medical community and patients of the risks of heart attack, heart failure, lung disease or pancreatic cancer.
If you or someone you love has suffered a heart attack, heart failure or death, please contact us today, you have rights and we may be able to get you the financial compensation you deserve.
Read more on the Actemra lawsuit in 2017.