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Actemra Injury Lawsuits Proof FDA-Approval Stamp Doesn’t Guarantee Safety

By | Actemra

FDA Approval Does Not Guarantee Safety

In an ideal world, we’d all be safe to assume that medications that are vetted and approved by the U.S. Food and Drug Administration are reasonably safe for our use because they have been thoroughly tested. Of course, no drug or medical device is entirely devoid of risk, but at the very least, we expect to have a heads-up about any major side effects or complications so we can make an informed decision. But as alleged complications with arthritis drug Actemra illustrate, that’s not necessarily true. Actemra injury lawsuits

Actemra, which goes by the generic name tocilizumab, is an intravenous drug typically prescribed for treatment of rheumatoid arthritis. Manufacturer Roche explains it works by reducing inflammation. The drug is also approved for treatment of giant cell arteritis, a type of blood vessel inflammation of the scalp, as well as some forms of arthritis in juveniles.

Actemra was released in 2010 after receiving FDA approval. Prior that approval, there was concern expressed in internal debates about whether Actemra could potentially be the next Vioxx, which was another arthritis medication that initially seemed safe and quickly grew popular, but was ultimately yanked from the market by manufacturer Merck & Co. in 2004 amid safety concerns when research linked it to thousands of deadly heart attacks. Some in the FDA were concerned that higher levels of blood lipids that were identified might lead to a risk of heart problems over a period of time. However, those concerns were ultimately overruled when the agency agreed to approve the drug, but on the condition that Roche sponsor multi-year studies to monitor the potentially negative effects. Read More

Actemra Injuries Underscore Opioids Aren’t the Only Drugs to Fear

By | Actemra

Actemra Injuries

Actemra injuries continue to be reported, while federal regulators and policymakers focus on dangers of other medications. Just a few months ago, a White House panel declared the epidemic of opioid abuse and deaths a “national public health emergency,” which is a designation typically reserved for natural disasters.Actemra injuries

While it’s true opioid abuse is extremely concerning – as an estimated 4 million Americans use opioids and an average of 142 people die daily from overdoses – these issues have eclipsed persistent and serious issues pertaining to other drugs, like Actemra.

Last year, STAT News conducted an in-depth report revealing 1,128 people who had reportedly died after taking the intravenous rheumatoid arthritis drug since it was approved in 2010. However, the agency has shied away from asserting Actemra was causal in those deaths. Even though this is the agency in charge of serving as a watchdog to the safety of prescription medications, it isn’t taking steps to verify those reports, STAT noted. Still, in looking at the individual reports, many of the physicians who submitted those complaints indicated their belief there was no other causal factor that could serve as an explanation. They included cases of fatal heart attacks, brain bleeds and pancreatitis. While many people are aware of the potential danger posed by opioids, fewer know about the risks of seemingly benign medications like these.  Read More

Roche Receives Approval in Europe for Actemra Sales, Even as U.S. Actemra Lawsuits Forge On

By | Actemra

Actemra Lawsuits 

Actemra Lawsuits: Reuters reports Swiss drugmaker Roche acquired approval for European distribution of Actemra, a medication prescribed for treatment of giant cell arteritis (GCA) and rheumatioid arthritis. The news is troubling as we in the U.S. continue to grapple with Actemra injury lawsuits and wrongful death lawsuits wherein plaintiffs allege the drug poses a heightened risk of stroke, heart attack, heart failure and other risks – dangers about which patients were never warned.Actemra injury attorney

Our Salt Lake City attorneys are reviewing product liability personal injury Actemra lawsuits involving patients who suffered serious or fatal injuries as a result of taking the arthritis drug.

It’s important to point out a lot of the newer rheumatoid arthritis drugs carry warnings indicating the risk of heart failure, heart attack, struck, lung disease and more. What initially made Actemra so exciting was it didn’t come with any of those risks – or at least, that’s what consumers were led to believe, given the lack of warnings. As noted in a widely-cited investigation by STATNews.com, there exists solid evidence that the risk of serious side effects and complications is just as high – if not higher – for Actemra patients compared to those prescribed similar drugs. Read More

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