No Warning for Patients about Complications from Taking Actemra

When new drugs are approved for use in the U.S.  healthcare system, patients have little choice but to place their trust in the drug’s label, and their doctor’s advice, regarding complications or side effects.  Unfortunately, there was no warning for patients about complications from taking Actemra (tocilizumab), a “groundbreaking” drug used to treat rheumatoid arthritis (RA).  As if not warning patients in the first place is bad enough, add the fact that the manufacturer, Roche, and the U.S.  Food and Drug Administration (FDA) are not taking action to ensure patients are warned about complications now that numerous adverse event reports have been filed.

At Brown & Brothers, we value the power of information.  In this post, we will discuss the complications from taking Actemra, the seriousness of manufacturers warning doctors and patients of risks, and what patients can do to protect themselves and their legal rights.

Actemra Promises Unfulfilled

When Actemra entered the U.S.  market, doctors and patients alike were offered the promise of treatment without the side effects typical of RA medications.  These typical side effects include heart failure, heart attacks, lung complications, and stroke.  Most RA medication labels include a warning for patients about the potential complications.  Upon reaching U.S.  markets, Actemra was not associated with any of these complications, and no warning label was included in their packaging.

With numerous complaints of adverse events being reported to the FDA since Actemra was approved in the U.S., publication STAT conducted an investigation into the complications of taking Actemra, and how the drug compares to other RA medications.  The results showed that complications from taking Actemra occur at the same rate or higher than other RA drugs, even though Actemra was not associated with the complications.

Complications from Taking Actemra

Since entering the U.S.  market in 2010, the FDA has reviewed the safety of Actemra several times.  Reports of complications from taking Actemra include serious, debilitating, and even fatal conditions, such as:

  • Stroke – Stroke may be caused by either a blood clot stopping supply to the brain, or a hemorrhage caused by a broken or bleeding blood vessel. Stroke is an emergent medical condition requiring immediate treatment.  Individuals who suffer a stroke may experience weakness or numbness, difficulty seeing, difficulty speaking, dizziness or loss of balance, or severe headache.  Depending on the type and severity of the stroke, individuals may suffer temporary effects, or may suffer permanent damage.
  • Heart Failure – Heart failure occurs when the heart cannot pump a sufficient amount of oxygen-rich blood throughout the body. Heart failure can take a serious toll on your entire body, and if left untreated can result in permanent or irreversible damage.
  • Heart Attack – Heart attacks affect over one million people every year in the U.S. Many people suffer severe or permanent damage, or die, due to their not recognizing the symptoms and getting treatment in a timely manner.  Symptoms of a heart attack may include chest discomfort, shortness of breath, upper body discomfort (neck, back, shoulder, or arms), dizziness, or nausea.  If heart attack is not treated in a timely manner, there may be permanent tissue damage, which can affect how well your heart is able to support your body and lifestyle.
  • Lung Complications – Individuals with RA commonly experience comorbid conditions like interstitial lung disease or weakened lung function, which increases the risk of complications. Lung complications, including development or worsening of various lung conditions have been linked to Actemra use with multiple adverse events reported.
  • Pancreatitis – The STAT investigation found 132 reports of patients taking Actemra developing pancreatitis. Of those, 26 died.  Pancreatitis is generally considered an uncommon disorder, which may be acute or chronic.  In many cases, treatment is successful.  If left untreated, however, or if complicated by other conditions, pancreatitis can have devastating or even deadly side effects.  Complications of pancreatitis include infection, kidney failure, difficulty breathing, malnutrition, diabetes, cysts, or pancreatic cancer.
  • Death – Since 2010, the FDA has received more than 1,100 reports of patients dying after taking Actemra.  Ongoing investigations are working to break down the individual side effects that contributed to these deaths (pancreatitis, heart attack, stroke, etc.), as well as determining just how significant a role Actemra played in the deaths.

Have you Experienced Complications from Taking Actemra?

The medical malpractice attorneys at Brown & Brothers have an eager interest in helping clients in Texas who may have suffered complications from taking Actemra.  Our firm helps clients protect their rights from negligent and unjust marketing on the part of drug manufacturers.

Drug manufacturers have a duty to doctors and patients to warn them of potential side effects.  Roche did not uphold this duty, and as a result, thousands of lives have been negatively affected.  Such negligence is unacceptable and should not go unaccounted for.

If you have suffered complications from taking Actemra or any other drug improperly labeled or marketed, contact our office for a free case evaluation.  Fill out our online form to start taking a stand against negligent manufacturers who fail to warn patients and protect their wellbeing.

Sources:

Actemra Lawsuits

Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients

Rheumatoid Arthritis Drug Actemra Linked to Heart Complications, Death