The U.S. Food and Drug Administration has identified a troubling number of reports of both pancreatitis and liver damage among patients taking the popular rheumatoid arthritis drug Actemra.
This comes on the heals of a large study last year that found Actemra had higher rates of heart attacks, strokes, heart failure or death than similar drugs, but didn’t warn patients of the dangers.
Now, based on the new information, the FDA has said it is evaluating the need for additional regulatory action against Actemra and its manufacturer, Roche.
FDA Report Identifies Actemra Pancreatitis, Liver Damage
In January, the FDA published its quarterly Potential Signals of Serious Risks/New Safety Information report that identifies new trends in reports of drug complications among patients.
For the period July – September 2017, the agency noted an increased number of reports of patients taking Actemra who developed pancreatitis or liver damage.
While the FDA didn’t disclose the actual number of reports received for either condition, or any indication of a possible cause, they did say they were evaluating the need for additional regulatory action.
The quarterly report is published as part of the agency’s attempts to flag potential safety issues in prescription drugs as required by the Food and Drug Administration Amendments Act of 2007.
It requires an unbiased review of the FDA Adverse Event Reporting System database at least every two weeks in order to identify trends in harmful side effects. After publishing the results, the agency must say what action it will take to protect the public.
Actemra Previously Tied to Heart and Stroke Risks
This isn’t the first time Actemra has landed in the news over possible health concerns. The drug was approved by the FDA in 2010 and is taken by more than 750,000 patients each year as a treatment for rheumatoid arthritis.
In 2012, an FDA study discovered more than 250 patients had reported pancreatitis and 185 suffered lung disease after taking Actemra, with no warning by the manufacturer, Roche.
Then, in 2016, researchers at Columbia University found that patients taking Actemra were one and a half times more likely to suffer heart attack or stroke than those taking competing drug Enbrel.
Last June, a large-scale study of more than 500,000 patient records obtained from the FDA under the Freedom of Information Act found that 1,128 patients had already died from heart disease, stroke or lung disease while taking Actemra.
Roche Accused of Hiding Actemra Dangers
Drugs like Actemra that suppress the body’s immune system to treat rheumatoid arthritis have historically been linked to a number of heart, lung and pancreatic side effects. What is most troubling, though, is that Actemra’s maker didn’t tell patients about these risks.
As early as 2010, when Actemra was launched, Roche tried to brand it as a safer alternative for RA treatment. In fact, it had as many risks as competing drugs, without the health warnings.
For example, similar drugs like Enbrel, Humira and Remicade warn of heart risks. Both Humira and Remicade warn of the risk for interstitial lung disease. And there is even a warning for stroke on the label of Humira.
Actemra, however, despite being shown to have similar risks for all these conditions, doesn’t have a warning on the label for any of them.
Based on the fact the maker of Actemra knew about these risks as early as 2010 but didn’t warn patients, lawyers are investigating cases for anyone who has been affected by heart attack, heart failure, stroke or lung disease.
Lawyers believe the lawsuits will eventually be consolidated to a class action-type MDL court due to the volume of patients and the expected number of cases.
If you or a loved one have questions about the side effects and studies liked to Actemra, or would like to speak directly with a lawyer about your case, contact DrugNews today.
Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FEARS): July – September 2017. FDA. (January 12, 2018). Retrieved from www.fda.gov
Piller, C. Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients. STAT News. (June 5, 2017). Retrieved from www.statnews.com
This past spring, the FDA issued a warning affecting the millions of patients each year that undergo routine gastrointestinal, gynecologic...
In the latest Invokana lawsuit update, DrugNews has learned that a federal judicial panel has transferred new cases alleging...