A new study has revealed a link between the popular painkiller Celebrex and 1,100 deaths. Although there is no evidence that these were CPF-related heart attacks or strokes, law experts say an increased risk of those outcomes cannot be denied either. What does this mean for other drugmakers?
The FDA has issued a warning that the pain medication known as Vioxx may have killed more than 1,100 people. The drug was introduced in 1999 and withdrawn from the market by 2004.
The “Actemra” is a drug that has been linked to 1,100 deaths. The FDA has yet to approve the drug, but it is still being prescribed.
More than 1,100 fatalities have been connected to Roche’s rheumatoid arthritis treatment Actemra, sparking concerns about why the drug lacks warning warnings regarding potentially lethal side effects.
Actemra has been linked to negative effects in the cardiovascular, pulmonary, gastrointestinal, and pancreatic systems.
Actemra (tocilizumab) is a competitor to arthritis drugs such as Humira, Remicade, and Enbrel. However, unlike its competitors, Actemra does not include a warning about the risks of heart attacks, heart failure, strokes, lung disease, pancreatitis, and gastrointestinal perforation, despite evidence that these risks are as high as or higher in patients taking Actemra than in patients taking competing drugs.
We’re keeping a careful eye on the new reports of Actemra-related fatalities and injuries. Please notify us if you have encountered serious Actemra side effects that were not mentioned on the label.
Actemra is implicated in 13,500 adverse event reports.
In 2010, Actemra was approved in the United States to treat the debilitating condition rheumatoid arthritis. Actemra was welcomed with open arms since it was allegedly free of the potentially fatal cardiovascular and pulmonary problems that plagued its rivals.
Actemra, however, is not as safe as the US Food and Drug Administration (FDA) and Roche would have you think, according to a recent STAT investigation. In fact, according to the STAT analysis, Actemra is at least as harmful as its rivals, if not more so.
STAT analyzed more than 500,000 adverse event reports about several rheumatoid arthritis drugs, including over 13,500 reports involving Actemra, and uncovered 1,128 reports of Actemra patients who died while taking the medication. Many of these patients died from unwarned against cardiovascular and pulmonary side effects.
The report’s highlights suggest several concerning patterns for Actemra users:
- More than 1,000 individuals have died as a result of taking Actemra.
- In comparison to rival medications such as Humira and Remicade, Actemra exhibited comparable rates of major side effects, despite the fact that Humira and Remicade had much more users.
- Users of Actemra and Humira have reported a comparable number of instances of interstitial lung disease, however Actemra users have reported many more cases of lung illness than Remicade users. Unlike Humira and Remicade, Actemra does not come with a lung disease warning.
- Heart attacks, strokes, and heart failure—conditions that Humira and Remicade warn against but Actemra does not—showed similar effects.
- In 132 Actemra patients, pancreatitis was documented. Twenty-six of the patients passed away. In its acute form, pancreatitis may kill up to 50% of patients.
- STAT recruited experts to examine the data, and the experts said the FDA should immediately consider Actemra warnings for heart failure and pancreatitis. They also said that the possible link between Actemra and increased risk of heart attacks, strokes, and interstitial lung disease should be further investigated.
STAT points out that reports of adverse events aren’t evidence of a link between Actemra and the reported fatalities. However, since these voluntary reports only catch around ten percent of unfavorable patient experiences, it is possible that patient fatalities are greater.
“There Were Some Warning Signs”
The STAT story isn’t the first to express alarm about Actemra’s adverse effects.
In five Actemra clinical studies, 72% of participants had a negative side effect. In 6% of patients, one or more significant adverse events occurred. During clinical testing, four individuals died of heart attacks, one of heart failure, and four of infections.
During the Actemra clinical trials, nine individuals died.
During a meeting of the FDA’s advisory group in 2008, infections, gastrointestinal perforations, cardiovascular problems, and other major side effects aroused considerable concern.
The panel voted ten to one in favor of Actemra’s approval. Diane Aronson, a consumer advocate, was the lone dissenter.
“As a ‘no’ voter, I thought there wasn’t enough evidence; it was too short-term,” Ms. Aronson said. There were several warning signs.”
She went on to say that ‘yes’ supporters believed that “long-term research would be taken into account” and that warning labels will be changed if required. Ms. Aronson said, “That’s why they voted yes.”
The FDA’s ties to Roche raise concerns.
Roche gained Actemra permission on the condition that it conduct Phase IV clinical studies, often known as post-marketing trials. When there is unclear data concerning a drug’s long-term safety, the FDA may propose these further safety studies.
The results of an Actemra phase IV study were reported at the 2016 American College of Rheumatology meeting. Patients on Actemra were compared to those taking Enbrel, a rival medicine. Stroke and heart failure were found to be 1.5 times more common in Actemra patients.
While the rise isn’t statistically significant, it doesn’t explain why Enbrel labels advise against providing the medicine to people with cardiovascular illness, yet Actemra hasn’t received similar warnings.
The Actemra Phase IV study’s 11 authors all acknowledged financial affiliations to Roche or Genetech.
Actemra has been reviewed by the FDA multiple times since its approval in 2010. Actemra users were found to have 258 incidences of pancreatitis and 185 cases of interstitial lung disease in a 2012 FDA assessment of data from numerous sources. The FDA failed to provide warning labels for these adverse effects due to lobbying from Roche.
The STAT report discusses potential conflicts of interest between the FDA and Roche, including a former FDA manager who oversaw Actemra’s approval before joining Roche, where he currently works with the FDA to secure clearance for new applications of the medicine. Furthermore, all eleven authors of a phase IV research published in 2016 that demonstrated no significant difference in cardiovascular risk between Actemra and Enbrel reported financial relationships to Roche or its affiliate Genentech.
The FDA discovered 118 fatalities connected with Actemra in a 2013 safety evaluation, including 42 deaths from heart attack or heart failure. However, the FDA declined to alter the medication’s labeling again again, claiming a lack of clear evidence of causation.
The FDA authorized Actemra for use in patients with giant cell arteritis in May 2017, broadening the patient pool for one of Roche’s best-selling medications. Actemra’s safety labeling, on the other hand, has yet to be expanded by the government.
Which begs the question: how many more deaths and injuries must occur before the FDA and Roche act?
The “actemra vs humira” is a drug that has been linked to 1,100 deaths. Actemra was prescribed to patients with rheumatoid arthritis and other autoimmune diseases. The drug was found to cause serious side effects including heart attack, stroke, blood clots, kidney failure, and death.
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