Rheumatoid arthritis (RA) remains a challenging condition for doctors to treat. It is an autoimmune disease that causes immune cells to attack and damage joints. It causes inflammation, swelling, and pain, and may eventually lead to loss of mobility. According to the Arthritis Foundation, RA affects about 1.5 million Americans and around three times as many women as men.
In January 2010, manufacturers Roche and subsidiary Genentech released Actemra (tocilizumab), a new drug designed to treat RA, for sale. The FDA approved it for the treatment of adult patients with moderately to severely active RA who had not found adequate relief with other similar medications.
Manufacturers advertised the drug as being a “unique” breakthrough that would “transform expectations” for doctors and their patients, implying the drug was superior to its predecessors. Unlike other similar drugs, Actemra allegedly wasn’t linked with heart attacks, heart failure, or lung complications. Other similar medications carried warnings about these types of side effects, but Actemra did not.
Now, however, a new report by STAT News suggests that the manufacturers may have made a serious mistake. STAT analyzed the over 500,000 adverse event reports submitted to the FDA for the drug. The results show that Actemra may be just as risky as other similar drugs when it comes to side effects like heart attacks and strokes.
What is Actemra?
Many RA drugs work by inhibiting or interfering with the action of cells or chemicals that enable the immune system to cause inflammation. The inflammation can damage the joints, and cause pain and swelling. There are several key proteins involved in the inflammatory process, including tumor necrosis factor-alpha (TNF-a) and interleukin-6 (IL-6). Patients with RA often show high levels of these and other related proteins in their blood.
Humira, another popular RA drug, works by blocking TNF-a, which is a source of inflammation that contributes to RA symptoms. In the process, however, it has been found to increase the risk of dangerous side effects like heart risks. When it came onto the market, Actemra was positioned as being different because it was the first RA drug to block the action of IL-6. Genentech stated in a press release that Actemra provided “a new option for patients with this very serious disease.”
Mark Genovese, M.D., and study investigator for the clinical trial used to gain Actemra FDA approval, stated, “[f]or many RA patients, treatment with existing therapies does not resolve painful and debilitating symptoms of the disease. Data from the clinical development program clearly establish Actemra and its unique mechanism of action as an important new option for RA patients who experience continued disease symptoms despite treatment with existing therapies.”
The drug was studied in five trials involving more than 4,000 patients and was found to significantly lower RA signs and symptoms, whether used alone or with methotrexate or other similar drugs.
Meanwhile, Actemra was seen as less risky than other similar RA drugs, because it supposedly did not increase the risk of heart problems. Roche, however, has been aware of potential issues with its drug since 2009 or earlier—a year before the drug was approved in the U.S.
Japan Reports Problems with Actemra Before U.S. Approval
In 2009, the Wall Street Journal reported that Actemra had been linked to 15 deaths in Japan. The drug was approved there in 2008, before it was approved in Europe or the U.S. Similar to the marking approach taken in the U.S., the manufacturers marketed the drug in Japan as having minor side effects compared to other similar RA drugs.
Less than a year after it was approved in Japan, the manufacturers began learning of problems associated with Actemra. Roche’s Japanese unit, Chugai Pharmaceutical, analyzed reports from nearly 5,000 Japanese patients who had taken Actemra between April 2008 and February 2009. According to the results, there were 15 deaths with possible links to the drug.
“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. The analysis also revealed 221 cases of serious side effects.
To gain approval in the U.S., the manufacturers relied on five Actemra studies. Though the FDA ultimately approved the drug. These studies showed some unusual side effects, including serious infections that could lead to hospitalization and death.
STAT Investigation Raises New Questions
This new investigation by STAT News has caused significant concern about how the drug is being marketed and prescribed. Actemra currently contains a black-box warning about infections, but not about heart attacks or strokes.
Yet the new report shows that many people who have taken the drug have suffered from these potentially life-threatening problems. Out of the 500,000 reports the investigators reviewed, they found that 1,128 people died after using the drug. Significantly, in many of the reports, the patient’s treating doctor indicated there was a link between their death and the use of the drug. The investigators also “found clear evidence” that the risks of heart attacks, strokes, and heart failure “were as high or higher for Actemra patients than for patients taking some competing drugs.”
STAT also cites experts who, after reviewing the analysis, have indicated that the drug should have new warnings added to the Actemra label to notify doctors and patients of the risk of heart failure and pancreatitis. Roche has not sought to update the warnings on the product label.
FDA Criticized for Failure to Follow-Up on Post-Marketing Reports
Actemra has been on the market in the U.S. for seven years now. Yet this is the first we’re hearing of these potentially serious side effects. Some critics had suggested the FDA needs to do a better job of tracking potential safety issues after a drug is approved and reaches the market.
For example, a recent study conducted by the Mayo Clinic and the Woman’s Hospital indicates that post-market safety events “are common after FDA approval,” highlighting the need for “continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
The Government Accountability Office (GAO) also reported in 2015 that the FDA was approving a lot of drugs without clinical trials (via their fast-track approval process), but that they lacked “reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities.”
According to these sources, the FDA remains ill equipped to make sure that drug safety problems are properly and timely addressed once the drugs are on the market and being prescribed to thousands and even millions of people.
Types of Injuries Associated with Actemra
Patients who take Actemra may be at risk for the following injuries:
- Heart attack
- Heart failure
- Life-threatening infections
- Gastrointestinal perforation (bowel perforation)
- Interstitial lung disease
Actemra Injury Lawsuits
This new report suggests that Actemra manufacturers may have failed to adequately warn doctors and patients of possible serious side effects associated with the drug, and may have ignored important information about these side effects. It also suggests that the manufacturers failed to conduct adequate studies on people with cardiovascular disease and other populations at risk for heart and lung problems.
If you or a loved one took Actemra and then suffered a heart attack, stroke, heart failure, or death, you may be eligible to file an Actemra lawsuit. Chaffin Luhana is now investigating these cases and invites you to call today at 1-888-316-2311.