Posted on 12/10/2004 6:26:44 PM PST by neverdem
By THE ASSOCIATED PRESS
WASHINGTON, Dec. 9 (AP) - The government is warning of potential heart problems associated with the use of the painkiller Bextra in people who have recently had heart bypass surgery.
The Food and Drug Administration said Thursday that it was adding the warning to the label of Bextra, as well as strengthening the label warnings on the possibility of severe skin reactions with the drug, which is made by Pfizer.
The F.D.A. said in a statement that "results from a new study of more than 1,500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than other patients who did not receive any drug."
The problems included heart attack, stroke and blood clots in the legs and the lungs, the F.D.A. said.
It said the new label would indicate that Bextra was not suggested for treatment of pain immediately after coronary bypass graft surgery.
Bextra is a type of painkiller known as a COX-2 inhibitor. The Merck arthritis drug Vioxx, also a COX-2 inhibitor, was withdrawn from the market because of findings that it increased the risk of heart attack and stroke.
These drugs have become widely prescribed in part because they are supposed to lower the rate of ulcers and gastrointestinal bleeding.
The F.D.A. is convening a panel in February to review all COX-2 inhibitors.
Shares of Pfizer fell 13 cents, to close at $27.37 on the New York Stock Exchange.
FReepmail me if you want on or off my health and science ping list.
Hmmm. Dad had Bextra post op last month. He has had a lot of problems with memory post op.
For decades I had doctors trying to get me on HRT - I didn't like reports I'd read on it - and didn't particularly think something made from horse p*ss could be all that good to take. I was proven right. Glad I didn't spend 30 years taking it.
a few years ago - after my heart attack - I was prescribed Baycol. I did research on it- didn't like what I read, and didn't take it. A year or so after that, it was taken off the market because it was killing people.
Then the statins - they are implicated in damage to heart and liver - nice. I stopped them.
Then I was taking vioxx for Osteoporosis - had no side effects, that I knew of. But now that's been yanked from the market = because it can cause heart attacks and stroke.
So, the question is: "Instead of the up-to-18 years of testing before a drug hits the market, are they now rushing them onto the market and waiting to see what happens to us - as the guinea pigs?
And where is the Food and Drug Administration? Aren't they supposed to protect us BEFORE we get killed?
Bottom line: We have to be proactive in our health care. We have to research any drug we're prescribed and make decisions. The Internet is invaluable and there are many "pill" books on the market...and don't be afraid to print out material and take it to your doctor.
Hmmmm. My Dad had bypass surgery three years ago and suffered memory loss and various other serious problems following. He never recovered. He was on Bextra following the surgery. He died on Dec 1, 2004.
You have my sincere sympathy for the loss of your father.
It is difficult. While drugs have saved and even extended many lives, there are those who either cannot handle the drug, or the drug is too risky. Having been diagnosed recently with RA....I've been on a rampage learning about drugs....it's not fun trying to decide what to take and what NOT to take. Lucky I found a good wholistic type MD...PLUS, the internet has been a GODSEND!!!!
Then the statins - they are implicated in damage to heart and liver - nice. I stopped them.
I'm unaware of statins being harmful to the heart. The last that I read, cardiologists still swear by statins. IIRC, three percent of folks can't tolerate statins because of liver toxicity, and one percent suffer from rhabdomyolysis, i.e. an acute, fulminating, potentially fatal disease of skeletal muscle that entails destruction of muscle, as evidenced by myoglobinemia and myoglobinuria. IIRC, Baycol was the only statin ever removed from the market.
The cerivastatin withdrawal crisis: a "post-mortem" analysis.
Then I was taking vioxx for Osteoporosis - had no side effects, that I knew of. But now that's been yanked from the market = because it can cause heart attacks and stroke.
I'm glad you're not taking vioxx for Osteoporosis, it was intended for osteoarthritis, other forms of arthritis, and analgesia for pain in general. FWIW, caveat emptor regarding medical info from the net.
"May you be in heaven a half hour before the devil knows that you're dead."
I wasn't aware that Bextra was a pain pill. I was told it was an anti-inflammatory pill, which caused the pain to go away, because the inflamation was taken away.
At any rate, I've taken Bextra for a year or so, for arthritis related back pain. Worked too. Presiption just ran out and so far it hasn't been refilled. Maybe the Doc has second thoughts about giving it to me anymore???
Interesting. Will go with Cuervo Gold for pain from now on!
The older non-steroidal anti-inflammatory drugs, NSAIDS, were also good for their use as analgesics or antipyretics, i.e. decrease fever. I haven't read about the COX-2 inhibitors being used to treat fever.
Thanks for posting this. I developed an allergic skin reaction to my gold necklace while taking bextra, but the doctor was skeptical that the two were related. Guess I was right.
ping
There is some implications that the statin drugs (HMG CoA-reductase inhibitors) are players in cardiomyopathy and congestive heart failure. In the course of disrupting LDL synthesis other factors are impacted, CoQ10 being the most celebrated. CoQ10 should always be supplemented as its levels drop sometimes dramatically with statin use.
Whether any of the bad press on statins is true is another story all together. Every major drug company has a dog in this fight and they are not about to allow any bad research out on this CASH COW!!!!
We will not know for years.
http://lipidsonline.org/slides/
This is a great site for blood lipid information for the layman and doctor. IMO the next real heart drug will be something along the lines of Singulair.
Ubiquinone: cholesterol's reclusive cousin.
One thing about large clinical studies is that they look at all cause and specific morbidity and mortality. In that regard, statins still hold a big lead as far as benefits over risks. Thanks for the other link.
I wonder who financed those studies??
Incidence of Hospitalized Rhabdomyolysis in Patients Treated With Lipid-Lowering Drugs
The financing of these studies has been fully disclosed for years, IIRC. Cardiologists and primary care docs would be having patients sign informed consent if they thought the prescribing of statins would cause another heart ailment.
Oh Really? Funny that has been the exact opposite that I have seen in my research into the SSRI issues. Positive drug studies are released, negative ones are killed and never see the light of day. Have you been following what is going on in the entire SSRI area? The FDA is trying to address the hiding negative study issue but there will be so many holes you could drive a truck filled with leftover Baycol and vioxx through it. The people that will implement and police these new policies are waiting to get cushy jobs at the same companies they are policing.
The people performing the studies are paid by Drug Companies and know which side their bread is buttered on. Which researcher is going to be stupid enough to torpedo Crestor after they are paid big bucks to "study" it? If you think any different you really need to take a step back and think about it. The advertising budget for statins gives one a clue just what this means to the bottom line of these companies.
Cardiologists and primary care docs would be having patients sign informed consent if they thought the prescribing of statins would cause another heart ailment.
Did psychologists get their juvenile patient's parents to sign such forms about paxil etc??
Now statins may be wonder drugs, I don't know. I hope they pan out to the hype they have been given. I just don't trust the bought and paid for studies. Do you remember how SSRIs were marketed. First for the extremely depressed, a few years later "clinical depression" became feeling down for a week or more, then it was PMS (remember the pink prosac!), then anxiety, then SAD, then children and on and on.
What about the statins first for very high cholesterol, then there is talk about people with what historically was normal cholesterol needing statins to improve their profile even in the absence of any heart disease, and now the cholesterol targets for many doctors are seen naturally only in a few teenage long distance runners. If you have diabetes you need a statin, normal cholesterol - statin and on and on.
Now I believe statins and SSRIs have their place in medicine cabinets. Just not in everyones like the commercials say.
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