The TZD Market is going to be completely pulled by the FDA on November 15, 2007 when final results come from the remaining two meta-analysis reports.
There are far too many alternative type treatments in place to manage and control type II diabetes at this time for the Food and Drug Administration to keep overlooking the huge potential side effect profile of the class of drugs called Thiazolidinedione (TZD).
TZD was first brought to market under the generic name: Troglitazone and trade name: Rezulin in the late 1990s by Parke Davis and Sankyo Pharmaceutical Companies and then withdrawn by the FDA on 21 March 2000 due to an increased incidence of drug-induced hepatitis that led to many deaths.
http://www.fda.gov/bbs/topics/NEWS/NEW00721.html
Earlier in 2007 both Actos and Avandia released two seperate black box warnings about potentially dangerous side effects: warnings about a condition in which the heart does not adequately pump blood. And an increased incidence of bone fracture was noted in female patients taking pioglitazone.
http://www.medicalnewstoday.com/articles/73582.php
http://www.medindia.net/news/view_news_main.asp?x=19105
Tomorrow, September 29, 2007 a leading Medical Journal called The Lancet is going to reveal startling results about another potentially deadly side effect concerning both the generic: Pioglitazone trade name: Actos and the generic: Rosiglitazone trade name: Avandia.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aPjZWUdkCqLY&refer=healthcare
http://www.thelancet.com/journals/lancet/article/PIIS0140673607615141/abstract
http://health.yahoo.com/news/179829;_ylt=An9Cro5ZEur45MZwmJPCbVKmxbAB
http://www.fda.gov/Medwatch/SAFETY/2007/safety07.htm#actos
http://www.fda.gov/Medwatch/SAFETY/2007/safety07.htm#rosi_pio
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazone200707HCP.htm
http://www.fda.gov/cder/drug/InfoSheets/HCP/pioglitazoneHCP.htm
http://www.nlm.nih.gov/medlineplus/news/fullstory_55439.html
http://health.usnews.com/usnews/hea...s-drugs-boost-heart-failure-but-not-death.htm
http://www.healthcentral.com/heart-disease/news-160944-31.html
Another "rumor" has recently surfaced in this past week alone that Actos is possibly increasing the rate of bladder cancer and investigations have immediately started exploring this concern.
---On a nother note, but related overall to this subject:
President Bush just signed into law Thursday September 27, 2007 the final agreement that allows the FDA the power to remove unstable and unsafe drugs from the United States of America prescription profile.
http://news.yahoo.com/s/ap/20070927/ap_on_go_pr_wh/drug_safety
Today, September 28, 2007 the FDA immediately went into action with this new power and gave all drug companies world wide 30 days to remove any drugs that they are selling in the United States of America that are Unapproved by the FDA and considered cough medicine that contain hydrocodone and marketed to children
http://health.yahoo.com/news/179866;_ylt=ArqEnaX9VY2EKLYzJmKj16ymxbAB
Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs.Apparently there are many drugs that fell into what was termed a "FDA Black Hole" and somehow slipped through federal regulated guidelines for specific metrics of gaining approval.
http://www.cnn.com/2007/HEALTH/conditions/09/26/unapproved.drugs/index.html?iref=mpstoryview
http://www.fda.gov/cder/drug/unapproved_drugs/
---late breaking news today announced a ground breaking step forward in the quest to make patient care the safest possible by the actual elimination of drugs that are linked to organ failure and/or even death.
It was also announced today that the 7 of the top Pharmaceutical Companies in the World will be coming together in an unprecedented meeting to compare unsafe side effect profiles of all the top selling products. The symposium is dubbed, International Severe Adverse Events Consortium. It is very odd that Takeda TPNA has opted not to participate in this forum, while their main competitor in the Type II Diabetes Market, GlaxoSmithKline is enrolled and ready to go to work in concert with the other 6 companies. The US FDA is applauding this effort to move forward in ensuring safetiness and compliance for all patients that suffer from a broad stroke of many disease states.
http://www.cnbc.com/id/21002275/for/cnbc
http://www.iht.com/articles/2007/09/27/business/drug.php
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11853
---And on one final note concerning both Actos and Avandia:
The FDA seems to have had ample evidence about the risks associated with Actos and Avandia. In 2006, FDA drug safety advisor Dr. Rosemary Johann-Liang urged the agency to add a black box warning to Actos and Avandia because of serious cardiovascular risks. Instead of heeding her warning, however, the agency reprimanded Johann-Liang and did nothing to adequately inform consumers about the possible risks associated with Actos and Avandia.
So for those of you nay-sayers that point fingers at Dr. Steven Nissen's claim that Actos is safer than Avandia has been now singled out as actually being paid large sums of research money by Takeda. If you actually think that Avandia is going bye bye and Actos is untouchable, I would highly recommend that you stop drinking the kool-aid and realistically start thinking about your future in terms of having employment.
There are far too many alternative type treatments in place to manage and control type II diabetes at this time for the Food and Drug Administration to keep overlooking the huge potential side effect profile of the class of drugs called Thiazolidinedione (TZD).
TZD was first brought to market under the generic name: Troglitazone and trade name: Rezulin in the late 1990s by Parke Davis and Sankyo Pharmaceutical Companies and then withdrawn by the FDA on 21 March 2000 due to an increased incidence of drug-induced hepatitis that led to many deaths.
http://www.fda.gov/bbs/topics/NEWS/NEW00721.html
Earlier in 2007 both Actos and Avandia released two seperate black box warnings about potentially dangerous side effects: warnings about a condition in which the heart does not adequately pump blood. And an increased incidence of bone fracture was noted in female patients taking pioglitazone.
http://www.medicalnewstoday.com/articles/73582.php
http://www.medindia.net/news/view_news_main.asp?x=19105
Tomorrow, September 29, 2007 a leading Medical Journal called The Lancet is going to reveal startling results about another potentially deadly side effect concerning both the generic: Pioglitazone trade name: Actos and the generic: Rosiglitazone trade name: Avandia.
http://www.bloomberg.com/apps/news?pid=20601202&sid=aPjZWUdkCqLY&refer=healthcare
http://www.thelancet.com/journals/lancet/article/PIIS0140673607615141/abstract
http://health.yahoo.com/news/179829;_ylt=An9Cro5ZEur45MZwmJPCbVKmxbAB
http://www.fda.gov/Medwatch/SAFETY/2007/safety07.htm#actos
http://www.fda.gov/Medwatch/SAFETY/2007/safety07.htm#rosi_pio
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html
http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazone200707HCP.htm
http://www.fda.gov/cder/drug/InfoSheets/HCP/pioglitazoneHCP.htm
http://www.nlm.nih.gov/medlineplus/news/fullstory_55439.html
http://health.usnews.com/usnews/hea...s-drugs-boost-heart-failure-but-not-death.htm
http://www.healthcentral.com/heart-disease/news-160944-31.html
Another "rumor" has recently surfaced in this past week alone that Actos is possibly increasing the rate of bladder cancer and investigations have immediately started exploring this concern.
---On a nother note, but related overall to this subject:
President Bush just signed into law Thursday September 27, 2007 the final agreement that allows the FDA the power to remove unstable and unsafe drugs from the United States of America prescription profile.
http://news.yahoo.com/s/ap/20070927/ap_on_go_pr_wh/drug_safety
Today, September 28, 2007 the FDA immediately went into action with this new power and gave all drug companies world wide 30 days to remove any drugs that they are selling in the United States of America that are Unapproved by the FDA and considered cough medicine that contain hydrocodone and marketed to children
http://health.yahoo.com/news/179866;_ylt=ArqEnaX9VY2EKLYzJmKj16ymxbAB
Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs.Apparently there are many drugs that fell into what was termed a "FDA Black Hole" and somehow slipped through federal regulated guidelines for specific metrics of gaining approval.
http://www.cnn.com/2007/HEALTH/conditions/09/26/unapproved.drugs/index.html?iref=mpstoryview
http://www.fda.gov/cder/drug/unapproved_drugs/
---late breaking news today announced a ground breaking step forward in the quest to make patient care the safest possible by the actual elimination of drugs that are linked to organ failure and/or even death.
It was also announced today that the 7 of the top Pharmaceutical Companies in the World will be coming together in an unprecedented meeting to compare unsafe side effect profiles of all the top selling products. The symposium is dubbed, International Severe Adverse Events Consortium. It is very odd that Takeda TPNA has opted not to participate in this forum, while their main competitor in the Type II Diabetes Market, GlaxoSmithKline is enrolled and ready to go to work in concert with the other 6 companies. The US FDA is applauding this effort to move forward in ensuring safetiness and compliance for all patients that suffer from a broad stroke of many disease states.
http://www.cnbc.com/id/21002275/for/cnbc
http://www.iht.com/articles/2007/09/27/business/drug.php
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11853
---And on one final note concerning both Actos and Avandia:
The FDA seems to have had ample evidence about the risks associated with Actos and Avandia. In 2006, FDA drug safety advisor Dr. Rosemary Johann-Liang urged the agency to add a black box warning to Actos and Avandia because of serious cardiovascular risks. Instead of heeding her warning, however, the agency reprimanded Johann-Liang and did nothing to adequately inform consumers about the possible risks associated with Actos and Avandia.
So for those of you nay-sayers that point fingers at Dr. Steven Nissen's claim that Actos is safer than Avandia has been now singled out as actually being paid large sums of research money by Takeda. If you actually think that Avandia is going bye bye and Actos is untouchable, I would highly recommend that you stop drinking the kool-aid and realistically start thinking about your future in terms of having employment.