UPDATE: (July 2018) – The U.S Food & Drug Administration is evaluating whether they need to take action regarding Actemra due to adverse event reports involving these three serious medical conditions:
- pulmonary hypertension;
- interstitial lung disease; and,
- pulmonary alveolar proteinosis.
UPDATE: (Jan.18, 2018) – A new study published in the medical journal ‘Modern Rheumatology‘ warns that Actemra increase the risk of blood loss for patients undergoing knee replacement surgery.
Actemra (tocilizumab), developed by Genentech (a member of the Roche group), was approved by the U.S. Food & Drug Administration (FDA) in 2010 to treat the following conditions:
- Moderate to severe rheumatoid arthritis in adults
- Active systemic juvenile idiopathic arthritis (SJIA)
- Polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older
- Giant cell arteritis
Taken intravenously or by injection, Actemra has been used by more than 760,000 patients globally and generated sales of $1.7 billion last year, making it Genentech/Roche’s fifth highest-grossing drug.
Unlike other similar arthritis drugs, Genentech/Roche did not warn about cardiovascular side effects on the label when the drug was released. A recent article published by STAT tells of hundreds of people taking Actemra who have died from heart attacks, stroke, heart failure and lung complications, revealing that life-threatening complications are occurring at the same frequency with Actemra as they are with other rheumatoid arthritis medications. However, while other manufacturers choose to warn the medical community and public of these risks, Genentech/Roche does not.
In fact, the FDA has received reports over 13,500 reports of adverse events related to Actemra including 1,100 reports of people who died after taking the drug. Since the FDA’s adverse event reporting system capture only a fraction of adverse events (estimated at about 10%), the actual number of deaths among Actemra users is certainly much, much higher.
In 2008, when FDA scientific advisors met to discuss the approval of Actemra, they recalled a notorious error made years earlier in the approval of another arthritis drug, Vioxx. Although risk of heart attack had not shown up in short-term clinical trials used in Vioxx’s approval process, tens of thousands of patients ultimately died of heart attacks linked to the drug.
A transcript of that Actemra meeting reveals Dr. David Felson, a Boston University rheumatologist said, “I can foresee the possibility that in five years there’s another hearing like the one on Vioxx, where the cardiologists… say to us, what were you guys thinking when you approved this drug?”
We are currently investigating cases where users of Actemra experienced one of the following severe side effects:
- Heart Failure
- Heart Attack
- Pancreatitis (which in its acute form can kill up to 50 percent of patients)
- Pulmonary Hypertension
- Interstitial Lung Disease (sometimes fatal scarring of the lungs)
- Pulmonary Alveolar Proteinosis
If you or a loved one have used Actemra and experienced a Heart Attack, Stroke, acute Pancreatitis, or been diagnosed with Pulmonary Hypertension or Interstitial Lung Disease, contact us online or call 1-866-252-3535 for a free consultation.