FAERS ANALYSIS LINKS RHEUMATOID ARTHRITIS DRUG TO HEART FAILURE AND PANCREATITIS
Actemra is a prescription drug developed and marketed by Genentech, a member of the Roche Group, for the treatment of moderate to severe rheumatoid arthritis in adults. Actemra has also been used to treat systemic juvenile idiopathic arthritis, also called still disease, in children over the age of 2 years.
However, a recent analysis of adverse events reports filed with the U.S. Food and Drug Administration (FDA) has raised new concerns that Actemra can result in serious and sometimes fatal side effects. Further complicating matters is the fact that these side effects are not included on Actemra’s warning label, leaving patients and healthcare professionals in the dark on potential risks.
SIDE EFFECTS ASSOCIATED WITH ACTEMRA
In a review of the FDA Adverse Event Reporting System (FAERS), experts determined that patients taking Actemra were at an increased risk of suffering the following side effects:
- Heart Failure
- Heart Attacks
- Interstitial Lung Disease
- Heart-Rhythm Disorder Tachycardia
- Hair Loss
In addition, the analysis concluded that at least 1,128 people died after taking Actemra.
ACTEMRA’S MANUFACTURER FOUGHT AGAINST STRICTER WARNINGS
In 2012, the FDA noted 258 cases of pancreatitis and 185 cases of interstitial lung disease among clinical trial participants treated with Actemra. In response to these findings, the FDA advised that Genentech update product labels to warn patients and doctors of an increased risk of pancreatitis and interstitial lung disease
However, Genentech fought against the inclusion of the new warnings citing lack of sufficient evidence. The FDA eventually yielded and the warnings were not added. Since then, the FDA has revisited Actemra safety concerns two other times.
INJURED BY ACTEMRA? CONTACT AN EXPERIENCED DANGEROUS DRUG LAWYER
If you or a loved one have been the victim of a dangerous drug like Actemra, contact Thomas J. Henry. Our team of experienced personal injury attorneys is available 24/7, nights and weekends. Let us hear your claim and provide you with a free case evaluation. If you have been injured by Actemra, you may be entitled to compensation for your pain and suffering.