By Tracy Colman  |  August 7, 2017

Category: Legal News

Actemra rheumatoid arthritis handsAccording to a report  by STAT, rheumatoid arthritis affects 1.5 million people in the U.S. alone. But one of the drugs that treat this often disfiguring disease, Actemra, comes with life-threatening risks, mostly affecting the heart and lungs.

When Actemra was approved for domestic distribution in 2010, it was surrounded with hope due to the apparent lack of associated problems. Unfortunately, Actemra injection side effects have of late spawned investigations into this once promising rheumatoid drug.

Serious Actemra Injection Side Effects

The Food and Drug Administration (FDA) has received notification that about 1,128 people that have died soon after taking Actemra. The FDA finds it difficult to determine whether the deaths are related to Actemra injection side effects or whether correlation does not equal causation in these cases.

Nevertheless, despite these adverse medical events resulting in death, many frequently reported Actemra injection side effects are not mentioned on Actemra’s warning label.

It is estimated that these reports represent only about 10% of actual cases, since many other cases go unreported. Other competing drugs such as Remicade and Humira all have labeled warnings regarding risk of stroke, heart attacks, pancreatitis, and lung diseases.

According to STAT, the serious alleged Actemra injection side effects like heart failure and pancreatitis should get a warning on the drug’s label. This conclusion was arrived at by expert evaluation of FDA death reports contracted by the news agency.

According to these experts, other problems worth further review by the FDA prior to requiring a label change would be heart attacks, strokes, and interstitial lung disease.

Another part of the problem with Actemra injection side effects being included on a black box label warning is that RA itself is a very problematic autoimmune disease that by its very nature is hard on the heart and body systems. In RA, unlike with osteoarthritis, the person’s immune system treats their own tissues as foreign and attacks them.

Frequent and Infrequent Actemra Injection Side Effects

Known Actemra injection side effects are separated by whether they are considered common or infrequently occurring statistically. Some of the more common ones are:

  • High Blood Pressure
  • Head Pain
  • Urinary Tract Infection
  • Infections of the Nose, Throat, and Sinuses
  • Throat Irritation

Some of the less common Actemra injection side effects are:

  • Excessive Triglycerides in the Blood
  • Excessive Fat in the Blood
  • Upper Abdominal Pain and/or Burning Stomach
  • Dizziness

What should be noted about these side effects is that they include symptoms such as high blood pressure, excessive fat in the blood, and excessive triglycerides. These are all factors that when added together are known risks for heart failure and cardiac arrest.

Actemra’s Current Status

Actemra’s manufacturers, Roche Inc. and its subsidiary Genentech, received $1.7 billion in Actemra sales in 2016. Worldwide it is estimated that about 760,000 people have used Actemra.

Sales may soon increase since the drug has had its approval expanded to include treatment of giant cell arteritis (GCA) in 2017. Doctors have also been known to treat patients with this drug for off-label purposes in up to 60 conditions other than rheumatoid arthritis (RA) and GCA as well.

In general, Actemra lawsuits are filed individually by each plaintiff and are not class actions.

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