When a new remedy for rheumatoid arthritis arrived, ads called it a “unique” breakthrough that would “transform expectations” for patients and doctors.
Treatments for the disabling disease afflicting about 1.5 million Americans can have terrifying side effects, so doctors and patients were excited when Actemra reached the U.S. market in 2010. Unlike competing drugs, it wasn’t associated with heart attacks, heart failure, or life-threatening lung complications.
Since then, more than 760,000 patients have used the drug. The FDA has received 1,128 reports of deaths in patients taking Actemra, yet cannot determine if the drug was the direct cause of the deaths.
STAT, an investigative publisher in the medical and biotech fields, analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.
Most of those medications warn about these risks on their labels. Actemra does not. Roche/Genentech, manufacturer of Actemra, is accused of not carrying a warning label stating a risk of heart attack or stroke as possible side effects for patients who take Actemra.
Actemra might not be more dangerous than other arthritis drugs — many of which can have lethal side effects — but patients and doctors are misled into believing it might be safer because frequently reported, serious problems aren’t noted on its warning label.
In one striking example, obtained through the Freedom of Information Act, a doctor said no factor other than the drug could have explained a 73-year-old man’s fatal brain bleed two days after receiving an intravenous Actemra treatment. Another said of a 62-year-old German woman’s heart attack in 2014: “The company assessed fatal myocardial infarction as related to [Actemra].”
That company was Roche/Genentech.
The failure to warn the public, experts say, highlights the FDA’s inability to adequately scrutinize the safety of drugs after they have been approved, and to act promptly when potential danger signs appear.
“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,” said Dr. Vinay Prasad, an oncologist and medical ethicist at the Oregon Health and Science University. “The system is broken, and all the financial incentives are lined up to keep it broken.”
Our product liability attorneys represent those who have been injured by medical devices and medications such as Actemra. For more than 25 years, our firm has fought against insurance companies and manufacturers on behalf of those who were injured through no fault of their own.
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