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Actemra Rheumatoid Arthritis Drug Tied to Significant Side Effects

Author: Parker Waichman LLP(i) : Contact: yourlawyer.com

Published: 2017-07-24 : (Rev. 2020-03-24)

Synopsis:

Actemra, manufactured by Roche/Genentech, has been associated with heart attack, heart failure, stroke, pancreatitis, lung disease, gastrointestinal perforation, and more.

Key Points:

Main Digest

Parker Waichman LLP, a national personal injury law firm dedicated to protecting the rights of victims injured by defective drugs, comments on investigation results involving the rheumatoid arthritis (RA) drug, Actemra (tocilizumab), which is manufactured by Roche/Genentech, revealed that hundreds of patient deaths were associated with the drug, according to a June 7, 2017, PharmaLive.com report.

Actemra is approved to treat adults diagnosed with moderate to severe active RA. The drug was approved in 2010 and has been prescribed to more than 760,000 patients*.

An investigation conducted by Stat News revealed that hundreds of patients taking Actemra died from cardiovascular and pulmonary complications, side effects not typically associated with the drug and that Actemra carried no warning labels concerning potential side effects.

Stat News indicated that it investigated more than 500,000 side effect reports for RA drugs and "found clear evidence" that the risk of the side effects such as heart attack or stroke, "were as high or higher for Actemra patients than for patients taking some competing drugs."

The difference, according to Stat News, is that Actemra, unlike the other RA drugs, does not carry a warning label for those side effects, reported PharmaLive.com

According to the analysis, the U.S. Food and Drug Administration (FDA) received 1,128 reports of deaths in patients taking Actemra; the FDA is unable to determine if Actemra was the direct cause of the deaths.

The Stat News report notes that;

"Though the agency is charged with monitoring the safety of prescription drugs, it doesn't verify the side-effect reports it receives."

Meanwhile, Stat News does cite a number of doctors' reports that suggest Actemra was significantly involved in the deaths of patients treated with Actemra. The doctors' comments about a suggested link between the deaths and Actemra were included; however, identities were not disclosed.

Stat News cited various experts who reviewed the analysis, concluding that the FDA must consider adding a warning label to Actemra for heart failure and pancreatitis.

According to PharmaLive.com, the experts also said that a failure to warn consumers "highlights the FDA's inability to adequately scrutinize the safety of drugs after they have been approved, and to act promptly when potential danger signs appear."

* http://www.pharmalive.com/hundreds-of-patient-deaths-linked-to-roches-ra-drug-actemra/

(i)Source/Reference: Parker Waichman LLP. Disabled World makes no warranties or representations in connection therewith. Content may have been edited for style, clarity or length.

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