FDA Approval Does Not Guarantee Safety
In an ideal world, we’d all be safe to assume that medications that are vetted and approved by the U.S. Food and Drug Administration are reasonably safe for our use because they have been thoroughly tested. Of course, no drug or medical device is entirely devoid of risk, but at the very least, we expect to have a heads-up about any major side effects or complications so we can make an informed decision. But as alleged complications with arthritis drug Actemra illustrate, that’s not necessarily true.
Actemra, which goes by the generic name tocilizumab, is an intravenous drug typically prescribed for treatment of rheumatoid arthritis. Manufacturer Roche explains it works by reducing inflammation. The drug is also approved for treatment of giant cell arteritis, a type of blood vessel inflammation of the scalp, as well as some forms of arthritis in juveniles.
Actemra was released in 2010 after receiving FDA approval. Prior that approval, there was concern expressed in internal debates about whether Actemra could potentially be the next Vioxx, which was another arthritis medication that initially seemed safe and quickly grew popular, but was ultimately yanked from the market by manufacturer Merck & Co. in 2004 amid safety concerns when research linked it to thousands of deadly heart attacks. Some in the FDA were concerned that higher levels of blood lipids that were identified might lead to a risk of heart problems over a period of time. However, those concerns were ultimately overruled when the agency agreed to approve the drug, but on the condition that Roche sponsor multi-year studies to monitor the potentially negative effects.
When Actemra was released, there were reportedly no issues identified during clinical tests that would indicate an increased risk of heart attacks, heart failure or lung problems. It fast became the company’s fifth most profitable drug.
Fast-forward to last year. That’s when STAT news scoured more than a half million FDA complaints and discovered hundreds of deaths were reportedly caused by under-labeled side effects of Actemra. The drug was reportedly implicated in some 1,100 patient deaths from heart disease, lung disease and stroke.
Actemra Injury Lawsuits
The problem, it seems and as is outlined in Actemra injury lawsuits, is not so much that Actemra is far more dangerous than other arthritis drugs that are on the market. In fact, it appears to carry many of the same risk as other drugs in its class (though the STAT report did point to evidence that the incidence rates for these conditions may be slightly higher with Actemra). The issue is the medication has no warning of the higher risk of heart attacks. So patients think they’re getting a drug that’s safer than they others, and also possibly failing to monitor certain tell-tale signs of heart issues for which they might otherwise be alert.
The FDA did add a warning to the label in 2011 for “fatal anaphylaxis” after two deaths were reported. However, no other labels have been added since. Roche conducted several studies on the issue of a causal link between Actemra and heart attacks, but insists there isn’t one. The STAT report was critical of Roche’s clinical studies.
Contact the James Esparza Law Group in Salt Lake City, Utah for more information on filing an Actemra injury lawsuit. Call (800) 745-4050.
Rheumatoid Arthritis Facts and Statistics, Rheumatoid Arthritis Support Network
More Blog Entries:
Actemra Injuries Underscore Opioids Aren’t the Only Drugs to Fear, March 21, 2018, Actemra Injury Lawsuits Blog