Vioxx, a non-steroidal anti-inflammatory (NSAID), was made by Merck & Co. Inc., and introduced to the American market in 1999. The company then voluntarily pulled the drug from the market in September 2004, after there were multiple reports of increased risk of heart attack and stroke associated with long-term, high-dose use.

Six investigators from the Mount Sinai School of Medicine analyzed 30 randomized placebo-controlled trials involving Vioxx  and 20,152 individuals. They published their findings in the November 23 issue of Archives of Internal Medicine.

What the researchers found is disturbing:

Their analysis showed that safety concerns arose almost four years before the drug was withdrawn from the market. Dr. [Joseph] Ross and his colleagues found that as of December 2000 — when 21 of the 30 studies had been completed — there was a strong concern that patients taking Vioxx were at a greater risk for adverse events or death from cardiovascular conditions or blood clots. Thereafter, collected data through June 2001 showed Vioxx to be associated with a 35 percent increase in risk of a cardiovascular event or death. The association with cardiovascular risk strengthened as more data became available. As of April 2002, the pooled analysis showed a 39 percent increased risk, and as of September 2004, a 43 percent increased risk.

If this is true, and it seems to be, how can the company have gotten away with this?

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Image: iStock.com

Post from: Blisstree

Vioxx (Rofecoxib) Dangers Known Earlier

Ok, it is official… Avandia will stay on the market.  The FDA voted an overwhelming yes to keeping the drug on the shelves.  They stated that they are recommending that there be warning labels for the elder population and high risk cardiac patients. 

And as you can guess, this is getting a bag of mixed emotions.  Will this stop the 1000’s of lawsuits that are currently existing due to Avandia’s heart implications?  I think not.  But it will give the pharmaceutical company more than a leg to stand on.

It is estimated that Avandia was responsible for contributing to 80,000 heart attacks over the last 8 years.  Can they point the finger solely at Avandia?  Were there pre-existing factors?  Who is to say, I will leave that one to the attorneys and such. 

It is a bit like the Vioxx scare a few years back.  Did all orthopedics stop prescribing this medication after the cardiac warnings and accusations came out?  Nope, not even close.  Heck, my orthopod even uses it himself.  But there were tons, and I mean tons, of money awarded in the courts. 

Time will tell how much of an effect the FDA approval has on the already suffering Avandia.  Will it bounce back?  I know that personally while I was at the doctor’s office this morning, the drug rep came skipping in pushing the use of Avandia and proclaiming it’s innocence.  What do you think?  Do you still take Avandia?  Do you have a heart condition?  Will you stay on the medicine?  So many questions, so little time! 

Post from: Blisstree

FDA Gives Avandia The OK To Stay On The Market

More than 6 million people worldwide have taken the drug sold by London-based GlaxoSmithKline PLC since it came on the market eight years ago. Pooled results of dozens of studies revealed a 43 percent higher risk of heart attack, according to the review published by the New England Journal of Medicine.

The numbers are fairly impressive and warrant concern and questions. Why was the medication approved in the first place? Why did it take this long for research to be done on Avandia if there was speculation?

When the drug was approved, “evidence was at best mixed” on its benefit, wrote the two doctors. Both have been frequent critics of the FDA’s failure to spot dangers in the drug approval process and its conduct in the case involving Vioxx. The popular arthritis medicine sold by Merck & Co. was taken off the market in 2004 when heart problems came to light after it had been taken by millions of people

We all remember the happenings that followed with the discovery of the increased cardiac risks of Vioxx. Will Avandia follow suit?

Bottom line in my opinion, if you are on Avandia and have heart disease, you need to ask questions. You and only you can protect yourself. As I always say, be your own advocate!

via CNN

Post from: Blisstree

Avandia Linked To An Increased Risk Of Heart Disease

Conflicting evidence abounds when it comes to the safety of NSAID pain relievers as they pertain to heart health. The best way to settle the issue would be to conduct a clinical trial (the gold standard of epidemiologic studies) that compares study participants who are given NSAIDs to those given placebo. Dr. Deepak L. Bhatt and colleagues at the Cleveland Clinic Foundation in Ohio are planning a clinical trial investigating the effect of NSAIDs on heart disease.

*COX-2 selective drugs include Bextra, Celebrex, and Vioxx

Reuters.co.uk, August 2, 2006
European Heart Journal, June 16, 2006

Post from: Blisstree

NSAID Painkillers Increase Risk of Heart Attack

On Monday, closing arguments were made in one of almost 10,000 trials. The current trial involved two men who suffered heart attacks after taking Vioxx. Merck argues that the two men already had many of the risk factors that predisposed them to heart attacks. The plaintiffs counter that Merck knew for many years Vioxx was linked to heart attacks and strokes and the drug should never have been considered an option for people with cardiovascular risk factors.

So far, Merck has won two trials and lost one. I haven’t formed an educated opinion on this one yet. Have you?

The Washington Post, April 3, 2006

Post from: Blisstree

Vioxx and Heart Attacks