If you think drugs approved by the FDA can’t kill you, think again. A recent article in Stat News explains that Actemra, a rheumatoid arthritis drug, has dangerous side effects, possibly killing hundreds of patients who took it. But, the FDA warning label made no mention of its risks of stroke, heart and lung disease, or pancreatitis. And, the FDA seems to be incapable of determining the drug’s safety or of acting to warn patients now that the drug shows signs of having dangerous side effects.
Somehow Actemra’s manufacturer, Genentech, a subsidiary of Roche, was able to persuade the FDA that, unlike other treatments for rheumatoid arthritis, Actemra did not have serious side effects. As it turns out, just like other drugs for rheumatoid arthritis, the data suggests that Actemra can cause stroke, heart disease, heart attack, lung disease and pancreatitis.
In fact Stat, which studied more than 500,000 reports of Actemra’s side effects, found that patients taking Actemra may be more likely to suffer a heart attack or a stroke than patients taking a competitor drug. Stat further reports that the FDA has been notified of 1,128 people taking Actemra who subsequently died.
The FDA doesn’t have the capability to determine whether Actemra was the cause of death, and the FDA is not responsible for determining the accuracy of Actemra’s side effects, as reported by Genentech. But, Stat learned through a Freedom of Information Act (FOIA) request that several doctors ascribe their patients’ deaths to Actemra. Experts Stat enlisted to review the FOIA information say that the evidence suggests that the Actemra warning should include risk of heart failure and pancreatitis.
Stat quotes oncologist and medical ethicist Vinay Prasad, Oregon Science University: “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.” Prasad continues: “The system is broken, and all the financial incentives are lined up to keep it broken.”
Psychiatrist, Jean Roiphe M.D., says: “It is safest to assume, until proven otherwise, that a new drug, from a given class of medication, is likely to have similar side effects and risks as other members of its class, even if there is no specific warning to that effect. Before deciding to take a newly approved drug, I recommend that patients consider taking a drug that has been around for a longer period of time, whose side effects are more well known.”
About 1.5 million Americans have rheumatoid arthritis. It causes swelling of the joints and, sometimes, physical disabilities. It can be extremely painful. (Click here for a post on managing arthritis pain.) There is no cure for the disease, but there are several types of treatments, including therapy and a range of medications.
You can watch Mike Papantonio, a trial lawyer, describe the dangerous side effects of Actemra here.
Here’s more from Just Care:
- More proof aspirin helps prevent heart attacks and stroke
- Side effects of drugs prescribed off-label are often serious
- Hundreds of new drugs are harmful or ineffective
- Taking supplements? You’re at risk for liver damage
- DailyMed: Know the potential harms of your prescriptions
- One in three FDA-approved drugs have safety risks