EU Bans Avandia & FDA Reports Actos Linked to Cancer

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EU Bans Avandia & FDA Reports Actos Linked to Cancer

Postby Parquet » Fri Sep 24, 2010 7:25 am

EU pulls plug on Glaxo's Avandia

EU pulls plug on Glaxo's Avandia, FDA restricts - European officials moved to pull GlaxoSmithKline's (GSK.L) diabetes drug Avandia off the market and U.S. authorities imposed tight restrictions over heart risks, effectively spelling the commercial end to the once-lucrative medicine. Once a top treatment choice and Glaxo's No. 2 seller, the rulings attempted to resolve a bitter, three-year debate over Avandia's safety that has dogged the reputation of the medicine and its maker, and divided staff inside the U.S. Food and Drug Administration.
http://biomedreports.com/articles/most- ... 23-10.html

The reasoning behind Avandia's U.S. stay of execution

The FDA also says it wants to keep Avandia on the market because patients already taking it might not want to switch drugs mid-regimen. The other reason is that some patients might benefit from regulating their blood sugar with that class of drug, and be unable to tolerate Actos. Given the extensive safety warnings tacked onto Avandia now, anyone else who takes it would have to (or as the FDA belives, may have no choice but to) play Russian roulette with their meds.

For the EU, the sheer risks of the drug outweigh the benefits. Lawsuits against GSK allege that tens of thousands of heart attacks and deaths stem from use of Avandia. That may be why the EMA banned the drug outright, and required that it be pulled from the market...

FDA not much for banning

That the FDA didn't ban Avandia isn't surprising. Once a drug is on the market, the FDA requires airtight evidence that it is killing people before pulling the trigger. Wyeth's diet drug Fen-Phen stayed on the market for almost 30 years until the FDA reviewed reports from independent physicians, and found that the drug was causing abnormal heart activity in almost a third of the people taking it. http://money.cnn.com/2010/09/24/news/co ... ney_latest

In another case, the attention deficit hyperactivity disorder drug Cylert stayed on the U.S. market for longer than Phen Fen. In 1995, a study showed that the drug caused a dangerous rate of liver failure in patients. Cylert was pulled in the UK immediately, but was available here for ten more years.
http://money.cnn.com/2010/09/24/news/co ... ney_latest

Why would the FDA believe people would switch to Actos if it banned Avandia? Their mega-study showed the ultra safe and ulta cheap Metformin to be more effective than either Avandia or Actos. Plus, I+n 2007 the FDA required a black box warning for both Avandia AND Actos. Also it seems that recent news indicates that Actos may be a worse choice as far as safety. A week ago the FDA published this report and a sponsored 10 year study of Actos:

FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure

Maybe my math is bad; but it seems that if a 10 year study showed increased cancer after the first 2 years, doesn't that mean that the FDA left the public unaware of the potential danger for the last 8 years?
Parquet
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