FDA Connected to Manufacturer of Deadly Arthritis Drug Actemra
Introduced in 2010, Actemra treats rheumatoid arthritis. Unlike other drugs on the market, it was supposed to not carry the same potentially deadly cardiovascular and lung complications. However, according to a new report from STAT, Actemra is not as safe as FDA and manufacturer, Roche would want consumers to believe. In fact, the STAT report suggests that Actemra can be more dangerous than its competitors.
Actemra More Deadly Than Competitors
The FDA approved Actemra with the condition that manufacturer Roche would perform Phase IV clinical trials (post-marketing trials). This is normal protocol when there is inconclusive evidence about a drug’s long-term safety. Researchers at the 2016 American College of Rheumatology showed the results from the Phase IV trial. After researchers compared Actemra users to a competitive RA drug, Enbrel, they found Actemra users have a 1.5 times higher rate of stroke and heart failure.
Enbrel has warning labels warning of these side effects but Actemra does not.
FDA Actemra Cover-up
When the FDA investigated Actemra in 2012 after receiving 258 cases of pancreatitis and 185 cases of interstitial lung disease (ILD), the FDA declined to add these side effects to the warning label. The STAT report uncovered that FDA did not demand a label change since they succumbed to pressure from Roche. Also noted in the report was that all 11 authors of the Phase IV study had financial ties to Roche.
Furthermore, in an ethical quandary, a former FDA manager, whose responsibility was managing Actemra’s approval left after the FDA approved it to work for Roche.
Deadly Side Effects
Just six years after approval, the FDA received nearly 14,000 side-effect reports involving Actemra. Some also implicated that Actermra was responsible for over 1,000 deaths. The causes of death listed in the majority of these FDA reports were heart disease, lung disease, and stroke.
In fact, the complaints to the FDA show that not only does manufacturer Roche fail to provide adequate warning labels, but also the drug may actually cause more adverse events than other drugs on the market. Moreover, those other drugs actually have accurate warning labels.
We Want to Help Victims
It is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one has developed pancreatitis and have taken Acterma, you should demand accountability. Why didn’t Roche tell you of these serious side effects?
We want to help send a message that this is not acceptable. If a dangerous product harmed you, we will be your advocate. Additionally, we have the experience necessary to successfully litigate these cases.
Contact The Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.