The Actemra lawsuit was filed in California by the US Food and Drug Administration (FDA) on January 7, 2019. The FDA is accusing Pfizer of deliberately withholding information about Actemra’s risk for causing blood clots. It alleges that this led to the deaths of several patients who were not aware they had developed a condition called thrombocytopenia due to their use of the drug.
Actemra is a drug that is used to treat rheumatoid arthritis. It was developed by the pharmaceutical company Actemra, Inc. In 2006, Actemra filed a lawsuit against the makers of its competitor drug, Synvisc-One. The lawsuit claimed that Actemra had been developing a safer and more effective treatment for rheumatoid arthritis before Synvisc-One came on the market.
When Roche’s Actemra was first announced in 2010, it was hailed as a game-changing treatment for rheumatoid arthritis.
“Actemra works differently,” according to the drug’s website, which shows a patient enthusiastically scuba diving and wandering on a beautiful beach. However, Roche makes no mention of key adverse effects that may have led to the deaths of over 1,100 patients.
More than 1,100 people died as a result of using Actemra. Roche might face legal action as a result of its failure to provide a warning.
According to research, people receiving Actemra had identical risks of heart attacks, heart failure, strokes, lung illness, and pancreatitis as those taking competitive rheumatoid arthritis treatments. However, unlike its competitors, Actemra’s label does not include a warning about these potential side effects.
Actemra safety allegations are being investigated by ClassAction.com’s lawyers. Please contact us for a free case evaluation if you or a loved one had heart, lung, or pancreatic adverse effects while using the medicine.
Side Effects of Actemra on the Heart and Lungs
The adequacy of Actemra’s safety warnings has been called into doubt by a STAT News investigation and postmarketing research.
More than 500,000 adverse event reports on prominent rheumatoid arthritis medicines, such as Actemra, Humira, and Remicade, were evaluated by STAT. Roche minimized Actemra’s cardiovascular, pancreatic, and pulmonary adverse effects, according to STAT.
According to STAT, the US Food and Drug Administration (FDA) received over 13,500 Actemra adverse event complaints from 2010 to 2016, with 1,128 people dying as a result of taking the drug.
While safety data suggests that the risks of heart attacks, strokes, heart failure, and interstitial lung disease are as high as or greater in Actemra patients than in individuals taking comparable treatments, Actemra’s warning label does not reflect these concerns, unlike its competitors’.
Actemra’s risk-benefit profile may not be fully understood by doctors and patients.
Patients on Actemra, for example, reported higher occurrences of interstitial lung disease than those taking Remicade, and roughly the same number as those taking Humira. Actemra, unlike Remicade and Humira, does not come with an interstitial lung disease warning.
STAT’s results are backed up by postmarketing studies, which are clinical investigations undertaken after a medicine is released to better understand drug hazards.
Actemra postmarketing studies were authorized by the FDA after premarket testing identified potentially dangerous adverse effects. When Actemra was compared to Enbrel, another arthritis medicine, researchers discovered that Actemra users had 1.5 times the risk of stroke and heart failure. Patients with cardiovascular problems should avoid using Enbrel. Despite equal or higher cardiovascular risks, Actemra has no corresponding warnings.
These results suggest that clinicians and patients may not be receiving the whole picture of Actemra’s risk-benefit profile.
Manufacturers of pharmaceuticals have a responsibility to warn consumers.
Pharmaceuticals aren’t supposed to be fully free of negative side effects. However, if a manufacturer is aware that a medicine poses a danger, it is required to include a warning label on the product. Patients and their physicians may then weigh all of the known dangers and benefits before deciding if a medicine is good for them.
While the FDA has the ability to require warning labels, drug makers are ultimately responsible. Since its approval in 2010, Actemra has drawn the attention of the FDA. The FDA contemplated including a pancreatitis warning label at one time. However, Genetech/Roche managed to persuade the FDA to remove the warning. Actemra’s usage for giant cell arteritis was later expanded by the FDA.
Patients must often resort to the legal system since the drug safety system cannot always be relied upon to prioritize patient safety.
The drug safety system is plagued by conflicts of interest between manufacturers and regulators. All 11 authors of an Actemra postmarketing research had financial relationships to Roche or Genetech, according to the STAT investigation. A former FDA manager who handled Actemra’s approval for rheumatoid arthritis now works at Roche, where he assists the company in obtaining FDA clearance for additional uses of the medicine.
To put it another way, the drug safety system cannot always be relied upon to prioritize patient safety. As a result, when patients are harmed by medication side effects, they often turn to the legal system for help.
Eligibility for an Actemra Lawsuit
We’re investigating allegations that Genetech/Roche neglected to tell patients about the following Actemra adverse effects:
- Angina pectoris
- Insufficiency of the heart
- Stroke
- Pancreatitis
- Interstitial lung disease (ILD) is a kind of lung illness that (lung tissue scarring)
Patients who took Actemra and had any of these adverse effects may be able to file a lawsuit.
Compensation that may be available
Victims of product liability cases are often compensated for the following losses:
- Medical bills from the past and present
- Wages lost in the past and in the future
- Suffering and pain
- Life quality has deteriorated.
- Losses incurred as a result of a loved one’s death, such as funeral costs
The amount of damages a plaintiff is entitled to is determined by the severity of their losses and other factors unique to them.
ClassAction.com Actemra Claims are being investigated.
While Actemra may assist with the devastating consequences of rheumatoid arthritis, there are still concerns regarding its safety.
Our lawyers at ClassAction.com have taken on some of the world’s largest and most powerful corporations, including pharmaceutical firms, and won billions of dollars for our clients. We have the knowledge and resources to handle complicated pharmaceutical cases, and we’re presently looking into Actemra claims.
Our lawyers want to hear from you if you or a loved one took Actemra and had a heart attack, heart failure, stroke, pancreatitis, or lung issues.
Please contact us immediately for a no-cost, no-obligation case analysis.
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- Actemra Lawsuit – Arthritis Drug Injury Lawyer near london