In a review based on 15,857 people who reported side effects while taking Actemra to the FDA, it was found that myocardial infarction (heart attack) was one of the common side effects after taking the medication for 5-10 years and was more likely to occur in males.
In a report published by the American College of Rheumatology, doctors monitored 2,957 RA patients comparing RA medication Enbrel to Actemra. Major adverse cardiovascular events (MACE) were recorded in both groups, but Actemra’s numbers were actually higher. In fact, instances of stroke and heart failure were sometimes higher.
The shocking part to these studies aren’t that these medications had similar side effects. It’s that Enbrel and other RA medications strongly warn patients of these adverse effects and this drug does not.
The supposed benefit to this medication was that it didn’t have the potential risks that other RA medications were linked to such as various heart complications. This led the public to believe that this medication was safer than its competition.
When Actemra was approved to be put on the market, it was considered to be a “breakthrough” medication because it showed “superior effectiveness” and was not known to cause “serious side effects of an available therapy”. This allowed this pharmaceutical to be ‘fast tracked’ through the FDA’s approval process. This means that Roche-Genentech, the makers of this drug, were able to bypass expensive, long term testing so that they could have it prescribed to RA patients sooner.
Actemra doesn’t list these warnings on their label or website, but many times has proven to be equal or worse than medications that do warn patients of the serious potential risks.
In 2013, the FDA required Roche-Genentech to conduct a full safety review of this medication. STAT News found that in the 3,500 reports to the FDA Adverse Event Reporting System (FAERS), 118 deaths were reported and 42 of those deaths were linked to cardiac arrest or myocardial infarction (heart attack). Nevertheless, The FDA concluded that no further label changes were warranted.
It is also crucial to mention that while these numbers seems terribly low, there are potentially tens of thousands of patients that haven’t reported their injuries to the FDA (most people don’t) or they possibly reported their injuries but the reports were incomplete and were disregarded. In fact, the former Commissioner of the FDA David A. Keller once said, “It is not the culture of U.S. medicine to report adverse events to the FDA”. He believed that only one percent of serious adverse events are ever reported to the FDA.
