A recent investigation by STAT News found hundreds of people died while taking the arthritis drug Actemra. Despite evidence pointing to an increased risk of heart attacks, strokes, heart failure, and other conditions for Actemra patients, neither Actemra’s manufacturer nor the U.S. Food and Administration has amended the product’s warning label.
This puts countless Americans at risk of serious side effects, including death.
What is Rheumatoid Arthritis?
Rheumatoid arthritis is a disease in which the immune system mistakenly attacks the joints, causing inflammation and swelling. Unchecked inflammation could lead to a loss of both cartilage and mobility.
An estimated 1.5 million people in the United States suffer from rheumatoid arthritis with nearly three times as many women as men diagnosed with the disease. The disease commonly develops between the ages of 30 and 60 and typically affects joints in the hands, feet, wrists, elbows, knees, and ankles.
Once joint damage occurs, it cannot be reversed. This is why doctors recommend early diagnosis and aggressive treatment to keep the arthritis in check.
What is Actemra?
Actemra was approved by the FDA in 2010 to treat rheumatoid arthritis and then in 2017 to treat giant cell arteritis. When the drug from Roche and its subsidiary Genentech was first introduced, it was touted as a safer alternative to arthritis treatments already on the market.
At the time, Actemra wasn’t associated with the risk of heart conditions or lung complications like other arthritis drugs. In the initial press release, Roche and Genentech called the approval “a major step forward in the treatment of RA, providing a new option for patients with this very serious disease.”
By 2016, Actemra became Roche’s fifth-best-selling medicine with first-half sales of $833 million. The numbers continued to increase in 2017 after its approval for treatment of giant cell arteritis.
How Does Actemra Work?
Actemra is in a class of drugs that inhibit the parts of the immune system that cause inflammation. According to WebMD, Actemra stops the protein interleukin-6 (IL-6) from reaching cells. The protein is believed to play a role in rheumatoid arthritis.
The drug is injected into a vein through an IV infusion or injected under the skin. IV infusions require administration by a healthcare provider while subcutaneous injections can be done at home.
Dosing and frequency of administration vary.
Actemra Side Effects
Like most drugs, Actemra users may experience some side effects. The most common side effects include (but are not limited to):
- Upper respiratory tract infections
- Injection site reactions
According to the prescribing information included with Actemra, other more serious side effects may include (but are not limited to):
- Serious infections
- Stomach perforations
- Low white blood cell counts
- Increase in blood cholesterol levels
- Certain cancers
Actemra Lawsuit and Controversy
Although some side effects are common in drugs, Actemra started raising red flags even before it was approved by the FDA.
In 2009, one study of nearly 5,000 people in Japan found Actemra to be a causal factor in the deaths of 15 people.
At the time, a spokesman for the Japanese unit of Roche said the company could not deny the relationship between the drug and the deaths.
“The fact that the causal relationship was not denied means there is a possibility that Actemra may have had an impact,” said Chugai spokesman Masayuki Yamada, according to Reuters in 2009.
Actemra had only been released for about a year before the reports of problems started coming out.
However, when approval was sought in the United States, Roche used five different studies on Actemra showing its safety and effectiveness.
STAT Uncovers Actemra’s Heart Risks
The issue of safety and effectiveness surrounding Actemra once again came to light after a June 2017 investigation by STAT News that looked into more than 500,000 side-effect reports on rheumatoid arthritis drugs. The medical-focused news organization found evidence that Actemra posed greater dangers to patients than competing drugs.
STAT’s Charles Piller analyzed thousands of reports submitted to the FDA, including more than a thousand involving people who died after taking Actemra. The FDA has reviewed the drug’s safety but doesn’t have the tools to determine whether Actemra was the cause of the deaths.
“Experts who examined the data at STAT’s request said the FDA should immediately consider warnings for heart failure and pancreatitis — an inflammation of the pancreas that in its acute form can kill up to 50 percent of patients,” Piller wrote.
The reports also indicated a higher risk of heart attacks, strokes, heart failure, and other heart-related conditions.
FDA and Roche Criticized for Actemra Inaction
The STAT report put more scrutiny on Roche and the FDA over post-marketing surveillance of drugs. Some researchers were concerned about the growing number of drugs being pushed through the approval process with inadequate information and a lack of post-marketing action.
“We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective,” Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University, said to STAT.
Others have cautioned against using reports submitted to the FDA as evidence since they can be false or contain a lack of useful information. Still, they can be revealing. In one report, a doctor said the fatal brain bleed of a 73-year-old could not be explained by anything other than Actemra.
Roche has not commented on the story, and the FDA has said that it continually monitors post-marketing safety and will inform the public of issues when they are identified.
Actemra Attorneys Investigating Failure to Warn Claims
The fact that nothing has been done in the face of growing evidence that Actemra may pose unexpected and dangerous risks puts the makers of Actemra at the center of potential lawsuits.
Attorneys around the country are now investigating whether patients have a case against the company over failure to warn claims.
Why File an Actemra Lawsuit?
Actemra has been on the market for more than seven years, and the dangers may have been known for longer. The makers of Actemra must be held accountable for not warning the public of potentially lethal risks to its drug.
Filing a lawsuit is an important step toward ensuring that drug manufacturers do not get away with dangerous business practices. On top of that, patients who were victims of the company’s failure to warn deserve compensation for injuries.