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A recent investigative report suggests that side effects of the rheumatoid arthritis drug Actemra may be linked to hundreds of deaths, resulting in calls for the FDA to add new label warnings to the drug about potential heart risks and strokes.
Actemra (tocilizumab) was introduced in 2010 by Roche as an immunosuppresive drug approved to treat rheumatoid arthritis. In May, the FDA expanded approval for the drug to also include treatment for adults with giant cell arteritis.
In an investigative report by Statnews.com, an analysis of adverse event reports submitted to the FDA links the drug to at least 1,128 deaths and thousands of serious side effects, including heart attack, stroke, heart failure, interstitial lung disease and pancreatitis.
STAT has requested that the FDA add new label warnings about the risk of Actemra side effects.
When Actemra was first approved, the report indicates that it was not linked to such health problems, which have traditionally been associated with similar drugs, which all carry label warnings about those health risks. However, postmarketing reports indicate that rates of such complications were “as high or higher for Actemra patients than for patients taking some competing drugs,” according to STAT.
Actemra does not currently carry such warnings, and despite several safety reviews federal regulators still have not required the information.
The investigative report notes that it is difficult for the FDA to act on the adverse event reports it receives, because the agency does not verify those reports, and they often lack important data and do not prove a causal link between those reported side effects and Actemra. However, some of the reports highlighted in the investigation specifically call Actemra as the only likely cause for brain bleeds, heart attacks and other severe side effects.
The report comes just a month after a study published by researchers from Yale and the Mayo Clinic found that new drugs approved by the FDA are commonly linked to serious side effects after the fact and later require updated label warnings.
In January 2016, a report by the Government Accountability Office (GAO) warned that the FDA was approving too many drugs through fact-track approval processes, and then failing to adequately monitor those drugs once they hit the market.
The GAO’s findings were similar to warnings issued in a report released by the Institute of Medicine of the National Academies in 2012, which found that the agency’s current approach to drug oversight after medications are approved is not sufficient and does not ensure that the benefits and risks of drugs are consistently monitored over the life cycle of the product.
While the FDA has said it is working on fixing the problem and that its postmarketing surveillance of drugs is improving, the GAO report pointed out that most of the possible drug safety issues the FDA already identified as potential problems were not being tracked through the FDA database. This could be because of the nature of the software the agency uses to update that data, which the review found to be problematic and likely made it harder for staffers to enter data.
The report comes at a time when the agency and pharmaceutical companies have called for ways to make it easier and cheaper to get new drugs on the market.