Actemra has been blamed for multiple patient deaths and injuries according to a recent study published by STAT News. There are reports of patients who were taking Actemra suffering fatal brain bleeds and heart attacks after receiving the drug.
According to one patient case study, a 73-year-old man suffered a fatal brain bleed just days after receiving an intravenous (IV) treatment of Actemra. A second example was a 62-year-old woman who suffered a fatal heart attack after receiving Actemra. Despite these and numerous other examples, Roche, the manufacturer and marketer of Actemra, have not changed warnings associated with the drug.
Demands Are Growing to Accurately Label Actemra's Side Effects in Packaging and Marketing
Many medical and pharmaceutical experts are demanding that the FDA force Roche to change its warning labels and marketing of Actemra in the name of patient safety. The FDA, however, is often very slow to act against drug companies and at times appears to side with them rather than acting in the name of patient safety. To date, the FDA’s only statement concerning Actemra is that they “continually monitor[s] post-marketing safety of approved drug products and remains committed to informing the public in a timely manner when the FDA identifies safety issues.” In light of reported deaths and other serious injuries associated with Actemra use one must wonder what the FDA considers a “safety issue.”
To be fair in reporting, Genentech and Roche cited a recent study that they claim is proof that Actemra does not cause an increase in the risk of heart attacks and strokes. The experts consulted by the STAT study dispute these claims by the manufacturer and stand by their claims that the drug does, in fact, cause a very high increased risk of injury compared to other RA (rheumatoid arthritis) drugs and patients not taking any medication.
The Devil Lies in the Details: Comparing Actemra to Vioxx
Vioxx was touted as a breakthrough drug just like Actemra. It was claimed to provide better results and be safer than the existing drugs at the time. The studies touted by the manufacturer were said to support these claims. Vioxx, however, was eventually pulled from the market after thousands of patient deaths and injuries were reported by users. When the studies were re-examined, it was evident that they were short-term studies that didn't demonstrate the true risk of the drug. Actemra appears to follow a similar route. The early short term studies appear to support the claims but new studies based on better data are demonstrating the true risk to patients, much like the scenario in Vioxx. Dr. David Felson, a leading rheumatologist from Boston University, was quoted as expressing worries over Actemra’s risk and comparing its problems to those of Vioxx. There was concern over patients on Actemra showing elevated levels of cholesterol and triglyceride, blood lipids that have been shown to cause heart disease over time. To say the least, the STAT studies are very concerning.
Many people taking Actemra are in vulnerable situations dealing with rheumatoid arthritis. RA affects both young and old and can cause devastating physical pain if not treated. Patients with RA are often looking for a miracle cure and willing to try a new medication. However, patients and their doctors are entitled to know the risks of the drugs they take and prescribe. Drug companies should not take advantage of this situation and manipulate the emotions and exploit the situation of these patients. They need to be honest.
Undisclosed Side Effects of Actemra Can Be Severe
Many patients taking Actemra have expressed side effects that are not mentioned in the drugs warnings and marketing materials. Cognitive sides effects such as memory loss and difficulty concentrating are common complaints of Actemra users according to recent data. There are no warnings on Actemra for such side effects. In fact, reviewing the data of Actemra shows that an unusually large number of patients taking Actemra experienced a large number of serious side effects that were not listed on the drugs warning label or in its marketing media. This was based on an initial review of reports to the FDA’s Adverse Events Reporting System known as FAERS involving Actemra users by Advera Health Analytics. The review of this data, which included more than 13,500 FAERS reports on Actemra, demonstrated a much higher than expected number of serious side effects compared to other RA drugs on the market such as Humira, Remicade, and Enbrel.
- Pancreatitis was reported in 132 patients (26 died). There is no warning for this on the label.
- Interstitial lung disease was reported in Actemra users that equal or exceeded users of Humira and Remicade. Actemra, unlike Humira or Remicade, has NO warnings for this condition.
- Heart attacks, strokes, and heart disease were also similar. And, unlike Humira and Remicade, Actemra has NO warnings for these conditions.
- One study that compared Actemra to Enbrel found rates of heart failure and strokes were 1.5 times higher in Actemra patients. Enbrel warns of heart failure and strokes. Actemra has no such warning.
Researchers Believe the Number of Severe Complications from Actemra Will Continue to Increase
It is beyond dispute that a closer look at Actemra safety is required. Perhaps the drug is as safe as its alternatives, perhaps it is not. Regardless, patients and their medical providers are entitled as a matter of safety to know the true risks of side effects such as heart attacks, strokes and lung disease when taking Actemra. The manufacturer should do the right thing and put patient safety first rather than worry about how much of their drug they can sell.
Want to Learn More? Our Kentucky Drug Injury Attorneys Are Standing By
If you or a loved one suffered a heart attack, stroke or sustained lung disease while taking Actemra, time is of the essence in contacting a lawyer. Many states have very strict limits on the time you are allowed to bring a lawsuit for a drug injury. If you believe you may have a case, or even just have a question, do not hesitate to act.
Gray & White Law, located in Louisville Kentucky, has represented hundreds of clients in Kentucky and across the nation in pharmaceutical drug injury cases. We have been extremely successful in obtaining millions of dollars in compensation for clients' medical costs, lost wages a, d pain and suffering. We have the resources, skill and experience to successfully handle these complex lawsuits. Contact us today for a FREE consultation.