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
From Daily Med:
WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Reported infections include:
Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1)].
Note: The side effects highlighted in the article are NOT listed. Do not rely on DailyMed to monitor your medications.
…this is why I am concerned about Jeff Sessions and his push to make possession/use of all forms of cannabis, including CBD, a federal felony with stiff prison sentences. Vice President Mike Pence shares similar views and should Mr Trump step down or be removed from office, arthritis suffers who use CBD balms, oil, and/or edibles will be at greater risk not only from a legal standpoint, but also health-wise as the only other options would be these dangerous drugs along with opiods and OTC NSAIDs (regular Ibuprofen use has recently been linked to heart disease and brain damage, while acetaminophen has been known for years to promote liver and kidney disorders).
CBD cannabis has no detrimental side effects and doesn’t get one “high” like the recreational THC variety does. What it does do is relax the joints and muscles while easing inflammation. It is also not addictive. I use it every couple days or when I get a flare up, not every day or even every few hours like pharma drug regimens require.
The real issue hat hand is the more people turn to this natural medications the less big pharma makes in profit for their dangerous and often addictive compounds. Already in some states that have legal open (no card or prescription needed) CBD sales. opioid use has fallen.
As long as the pharma lobby exists and continues to buy off our public officials, us arthritics will be faced with the choice either just sucking it up and suffering, poisoning ourselves with these poorly tested and/or mislabelled drugs, or risking years in prison (most likely in a privately run one).