Is Actemra a safe and effective drug for rheumatoid arthritis (RA) or does it pose risks of serious injury and even death that are not even listed among its side effects?
When Actemra first appeared to treat RA, it seemed promising. It was a first-in-class drugs, meaning it worked in a new way, and it had been approved in Japan since 2008 with what seemed to be minor side effects, such as high blood pressure, compared to other RA drugs. RA is a painful disease which limits movement, and over 1.5 million Americans have it, meaning that a safe and effective drug is sorely needed.
However, 2009 reports showed more severe problems in people taking the drug, including fifteen deaths. While the drug couldn’t definitely be said to be at fault, it couldn’t be ruled out either, and Actemra’s Phase III testing for approval by the Food and Drug Administration (FDA) included five multi-national studies in forty-one countries. Some potentially serious side effects—including serious infections, gastrointestinal performations, and life-threatening allergic reactions—did show up, but they were rare, and not as bad as the heart attacks, heart failure, and life-threatening lung complications. The drug was seen as a breakthrough, with a reasonable balance of risks and rewards.
Unfortunately, a recent investigation by STAT, a science and medical news site, has shown that patients who take Actemra may be at greater risk than was thought—and not from the side effects that were found during testing. It seems that patients also risk heart failure, heart attack, stroke, pancreatitis, and lung disease.
In fact, the FDA has received over 1,100 reports of deaths of people taking Actemra. It is not certain that the deaths were caused by the drug, and while it has been reviewed by the FDA, the agency cannot conduct the kind of testing that could determine for certain whether the drug was the cause of the deaths.
That’s left to the drug’s maker, Roche, but STAT reports that a senior director of rheumatology products there claims that they have a study that provides “definitive” proof that the drug does not cause cardiovascular problems. Last year, however, the drug earned $1.7 billion for the company, including for “off-label” uses to treat about sixty other conditions, so the company itself may not be the best place to look for unbiased opinions.
The FDA understands that it needs better systems for monitoring drugs after they’re put on the market. In the meantime, patients are still being prescribed the drug, and the labeling and insert do not list these more serious potential side effects.
We’re investigating. If you or a loved one has taken this drug and had negative side effects, we’d like to hear what you experienced. Fill out this form for a free consultation with an attorney to evaluate your options.
Article Type: InvestigationTopic: Medical Devices
