Does Actemra Have the Same Risks as Vioxx?

Actemra is an injectable drug used for aduIts who suffer from rheumatoid arthritis, and the resulting chronic inflammation. Actemra, granted FDA approval in 2010, and manufactured by Roche and its Genentech unit, is believed to work by blocking inflammatory agents in the body. Because the more than 1.5 million Americans who take traditional prescription drug treatments for rheumatoid arthritis suffer serious side effects such as lung complications, heart attacks and heart failure, Actemra, which initially appeared to have none of these side effects, was greeted with delight by patients and doctors alike.

What these patients likely did not know was that health concerns regarding Actemra first emerged in a 2009 Japanese study, before Actemra even received approval from the FDA. In this study, 15 of the 5,000 study participants died, and another 221 developed severe side effects such as pneumonia and high fever. Another study, published just a month ago by STAT, indicated that the complications associated with Actemra couId well be as high—or even higher—than similar drugs, such as Vioxx.

Further, the current competing drugs mostly warn patients of the potential risks, while Actemra fails to do so. Vioxx also failed to disclose potential risks to patients. The drug Celebrex quickly took Vioxx’s spot, and is still on the market today, although there has been a drop in the number of prescriptions after information about NSAIDs’ link to adverse gastrointestinal side effects came to light. What Actemra and Vioxx also seem to have in common is that it took a long time for the risks surrounding Vioxx to emerge—and the risks associated with Actemra couId cost the manufacturer.

The manufacturer of Vioxx, MSD, made approximately $11 billion in revenues during marketing, but has already spend a reported $6 billion in litigation. According to the STAT report, out of the 13,500 side-effect reports for Actemra, 1,128 patients taking the drug died. A 2016 study indicated that Actemra patients had 50 percent more heart attacks and strokes than patients taking Enbrel, yet Enbrel’s labeling has prominent warnings about a patient’s potential for developing cardiovascular disease when taking the drug. The numerous serious side effects associated with Actemra include the following :

  • Stroke
  • Pancreatitis
  • Heart attack
  • Heart failure
  • Gastrointestinal perforation
  • Infection
  • Interstitial lung disease
  • Death

Additionally, more than 5 percent of Actemra patients experience injection reactions, increased ALT blood levels, high blood pressure, runny nose, upper respiratory tract infections and headaches.

Is Genentech Guilty of Failure to Warn?

At this point, it appears Genentech was aware of the adverse health issues associated with Actemra, yet continued marketing the drug to the public. The current Actemra lawsuits are making the assertion that Genentech failed to warn physicians and patients of the serious side effects associated with Actemra, and it appears the FDA couId potentially be on the hook for failure to warn as well. While the FDA is supposed to monitor the safety of prescription drugs, the agency often fails to verify the side-effect reports it receives. As an example, a 73-year old man suffered a fatal brain bleed just two days after receiving an Actemra injection, yet despite this—and many other similar reports— neither Genentech nor the FDA has made any move to change the label on Actemra in order to alert patients to the potential risks.

If you or a loved one has suffered serious injury after taking Actemra, it is important that you contact an experienced Philadelphia dangerous drug attorney as soon as possible. Your attorney will work hard on your behalf to secure the settlement you are entitled to.

To learn more about your legal options or to scheduIe a free consuItation with an attorney, please call the Philadelphia dangerous drug lawyers at Golomb Legaltoday at (215) 278-4449 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legalhave successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.