Actemra cautions, January 2010

[kageyd]

The new drug, Actemra, recently FDA approved for use in the U.S., is not without its dangers, the most important of which is diminished ability to fight infections of any kind. The following web site, dated Jan 8, 2010, lays out the cautions that are not spelled out in the recent Roche/Genentech web sites. I am certainly not opposed to biologics that have tremendous positive potential, as this one seems to have from its clinical trials - after all, it is now FDA approved for RA - but I am always concerned that too many people ignore the reality of potential side effects.

http://www.drugs.com/actemra.html

[crimson]

Here is a PDF file regarding Actemra, In my opinion even though it is FDA approved, we have to still be cautious in using this.

http://www.roactemra.com/portal/synergy/static/file/synergy/alfproxy/download/1414-56de3c52e8c111dd89920d8bcd668025/last/lab_values_card.pdf

[adhityaen]

here is my part of contribution to medication with Actemra;

Actemra Approved for Rheumatoid Arthritis
For people who haven't responded to other RA drugs


HealthDay

By Scott Roberts

Monday, January 11, 2010

MONDAY, Jan. 11 (HealthDay News) -- Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat rheumatoid arthritis among people who haven't responded to, or who cannot tolerate, other approved RA drugs, the agency said Monday.

Actemra was approved for limited use because of adverse reactions noted in clinical trials, including the possibility of elevated liver enzymes, elevated "bad" cholesterol (LDL), hypertension, and gastrointestinal perforations, the agency said in a news release.

Actemra blocks an immune system protein called interleukin-6, which is found in excess in people with rheumatoid arthritis.

As a condition of the approval, San Francisco-based Genentech, the drug's marketer, must conduct additional clinical studies to evaluate the drug's long-term effectiveness and cardiovascular safety, the FDA said.

The agency said it also is requiring development of a Risk Evaluation and Mitigation Strategy for doctors, to inform physicians on how to monitor patients for possible liver or gastrointestinal side effects.

The most common adverse effects found in clinical testing included upper respiratory infections and other "serious" infections, headache, nasal and sinus inflammation, high blood pressure and increased liver enzymes, the agency said."

courtesy: http://www.nlm.nih.gov/medlineplus/news/fullstory_93947.html