Actemra Legal Information
Actemra, a medication used to treat rheumatoid arthritis, has been linked to life-threatening side effects such as heart attack, interstitial lung failure, stroke and GI perforation. If you or a loved one have been injured after using Actemra, you may be eligible for financial compensation for your injuries.
A June 2017 STAT News report has called for new warnings on the rheumatoid arthritis medication, Actemra. The report identifies an increase in risk for heart attack, stroke, interstitial lung failure and GI perforation and though no causal link has been established, shows that 1,128 cardiovascular and pulmonary deaths in Actemra patients have been reported to the FDA.
Actemra (tocilizumab) is an injectable medication used to treat autoimmune disorders including Rheumatoid Arthritis (RA) in adults, Systemic Juvenile Idiopathic arthritis (SJIA) and Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients over the age of two. It was also recently approved for use in patients with Giant Cell Arteritis (GCA).
Autoimmune disorders occur when the immune system begins attacking the body’s own tissue as if it were foreign material. Rheumatoid arthritis is an disorder in which the immune system begins attacking the patient’s own joint tissue. Over time, the inflammatory processes may lead to destruction of joint tissue resulting in swelling, pain and disability. GCA is a rare type auto-immune disease which affects the arteries of the head, neck and arms and may lead to blindness, aortic aneurysm, stroke and death.
Actemra is an immunosuppressive, monoclonal antibody drug, which works to fight inflammatory responses in patients with autoimmune disorders like RA. Actemra works by blocking one of the immune system messengers, interleukin-6 and was designed to be an improvement over other biologics like Humira, Enbrel and Remicade which work in a slightly different way.
Actemra is given only by IV infusion for juvenile arthritis but may be prescribed as a prefilled syringe to be given at home by subcutaneous (SC) injection for RA and GCA. Doses are repeated every 4 weeks for most patients but may require adjustments based on laboratory testing.
Since its approval in 2010, over 760,000 prescriptions have been written for Actemra and the drug made $1.7 billion for its manufacturer, Genentech and parent company, Roche last year alone.
Lack of safety warnings
Immunosuppressive agents have helped millions of patients but their actions also carry a number of risks. The FDA has required that IL-2 inhibitors carry the same black-box warnings about the risk of infections including tuberculosis, invasive fungal infection and opportunistic infections as other immunologic medications like Humira, Enbrel and Remicade.
These medications however, also include safety information or warnings about heart failure, lung disease, pancreatitis, heart attack or stroke which may be fatal. Actemra’s prescribing information does not include these risks, which may lead some to believe the medication is safer. Unfortunately, new information reported by STAT News suggests that the risks may be greater than previously identified or listed on package inserts.
Researchers reviewed tens of thousands of FDA serious adverse event reports of antirheumatic medications, including 1,128 deaths associated with Actemra. When compared to other immunosuppressive biologics, STAT found that life-threatening side effects occurred just as frequently or in some cases, more frequently in Actemra patients.
STAT reports its comparison showed that Actemra patients were:
- 50% more likely to have heart attack or stroke than patients taking Enbrel
- As likely to experience lung disease incident as those taking Humira and more likely than Remicade users.
The FDA has not established a direct link between Actemra and the more-than 1,100 reports of cardiovascular and respiratory death but experts have stated that the current adverse event reporting system may be making it harder to identify.
STAT News has called for warnings about life-threatening risks of heart attack, stroke, lung disease and GI tears or perforation to be added to prescribing information for Actemra.
Side effects of Actemra
Actemra, like all medications, may cause side effects which can range from mild or moderate symptoms to more severe reactions and life-threatening events.
Common side effects identified for Actemra include:
- Upper respiratory tract infection
- Increased blood pressure
- Injection site reaction
- Laboratory test changes
- Increased liver enzymes (ALT)
- Low white blood cell counts
- Low platelet levels
- High blood cholesterol levels
Laboratory monitoring of liver function and blood cell counts should be performed routinely. Drug may require dosing adjustment, treatment delay or discontinuation based on laboratory results.
Severe side effects of Actemra
Actemra has been associated with an increased risk for side effects which may be severe. Serious adverse events may require hospitalization and can be life-threatening. Serious side effects of Actemra may include
Actemra is an immunosuppressant which lowers the ability to fight infection. This may increase the risk of getting an infection, increase the severity of some infections, and make it more difficult to treat some infections.
Infections may include:
- Increased risk of common illnesses like colds and flu
- Risk of less common infections including
- Invasive fungal infections like candidiasis, aspergillus or pneumocystis
- Opportunistic infections due bacteria, viruses and other microorganisms
- Recurring infections may require longer or more complex antibiotic treatments
- Activation of latent tuberculosis even when pre-treatment TB test was “negative”
- Reactivation of Herpes Zoster, Hepatitis B or other viral infections
Because of the increased risk of infection, patients should be closely monitored for any symptoms. Symptoms of TB, Hepatitis, fungal infection or opportunistic infection may warrant treatment delay or discontinuation.
Severe Allergic reaction
Severe allergic reactions including anaphylaxis and death associated with Actemra use have been reported. Symptoms of allergic reaction include:
- Hives, rash, flushing
- Shortness of breath or difficulty breathing
- Swelling of lips, tongue or face
- Chest pain
- Dizziness or fainting
- Severe abdominal pain, vomiting
Actemra has been associated with a higher-than-normal risk of GI perforation. This risk was increased if the patient was taking other medications known to irritate the GI tract like NSAIDS, corticosteroids or methotrexate used for RA.
Unlike other immunosuppressive drugs used to treat RA, current Actemra prescribing information does not list warnings about potential effects on the heart or lungs. The recent STAT News investigative report shows that 1,128 deaths associated with Actemra use have been reported to the FDA, along with thousands of other serious adverse events involving heart attack, lung disease, stroke and GI perforation
STAT indicates that the FDA has not been able to determine the cause, however some industry experts have said that the reporting system is flawed. The US approval process may not require enough long-term safety data and post-approval safety monitoring is often based largely on “voluntary” reporting.
Actemra’s manufacturer, Genentech/Roche has said that they intend to investigate the issue but no official communication has been issued by the company or the FDA.
Patients and family members of those who have been harmed while taking medications like Actemra may be eligible for compensation for their injuries. Past medical injury claims have resulted in financial compensation for medical costs, lost wages, and pain and suffering. In some cases, if it can be proven that manufacturers knew of a drugs risks and failed to disclose the dangers, plaintiffs have also received punitive damages.
Patients or loved ones of those who experienced heart attack, stroke, heart failure, lung disease, or who died while taking Actemra should seek legal expertise.