Expert Warns Against 5 FDA-Approved Drugs

[OhioChick]

WASHINGTON - At least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised safety questions earlier about the arthritis drug Vioxx.

In testimony Thursday before the Senate Finance Committee, Food and Drug Administration (news - web sites) reviewer David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent. Drug makers defended the use and safety of their products.

Graham contended the country is "virtually defenseless" against a repeat of the Vioxx debacle. Dr. Steven Galson of the FDA (news - web sites) rejected that comment as having "no basis in fact."

Merck & Co. pulled Vioxx from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.
http://story.news.yahoo.com/news?tmpl=story&e=1&u=/ap/20041119/ap_on_go_ca_st_pe/vioxx_safety

[phaseolus]

1. accutane ruined my wife's knees

She took part in accutane clinical trials when she was nine years old. Since she was born with a rare skin condition her parents were ready to try anything, and accutane looked promising. Accutane is never prescribed to young children because of the effects they saw it had on my wife -- it messed around with bone growth, one of her legs is permanently crooked, and she has almost no cartilage in her knees. She'll probably need new knees some day, no doubt right after they kill medicare...

...and who the hell makes up those stupid names they use for drugs these days???

[OhioChick]

2. That's terrible....

I'm sorry to hear about your wife. I understand that Accutane is also responsible for many suicides amongst teenagers, and they've known this for YEARS.........

[otohara]

4. My Eyes Went From 20/20 to Shit

it makes you highly photosensitive - the sun and bright lights killed my eyes. Driving to Boulder when the sun was setting was painful and within a year I had to get glasses.

Even now, 11 years later, bright lights bother me.

[Straight Shooter]

24. who the hell makes up these stupid names for drugs?

Same people who make up the stupid names for military assaults

[xpunkisneatx]

26. thats cause it has retinoic acid in it

Retinoic acid is a molecule that is ubiquitous during the growth years.

[Sparky McGruff]

28. Accutane IS retinoic acid...

...and retinoic acid is essentially vitamin A. It's a very important factor in the growth of many organs (heart, limbs, face, brain), and it continues to play a role in the maintainence of the brain. People who overdose on vitamin A (either as Accutane/Isotretinoin or as "vitamin a"/retinol supplements) have horrible effects. The cut in stone effects include massive headaches and severe pain. Psychosis is also reported in numerous case studies, however, the link isn't 100% clear. On the other hand, without vitamin A, terrible and permanent damage to the eyes and spinal cord occur, among other things.

I have done a fair amount of work on the effects of retinoic acid in the nervous system (fetal and adult), and I can tell you that it's a very powerful drug. There are probably a few conditions that merit its use, but they should be CAREFULLY monitored by a physician. Then again, so should prolonged use of steroids (e.g. prednisone), which cause all sorts of side effects, including more than a few reports of psychosis following long term use at high doses.

The drug that wasn't mentioned that I wonder about is "Zelnorm". I see the ads for it, and I wonder why it was only approved for use in women. It makes me wonder if they "juggled the data" to meet statistical significance by dropping out half of a dicey data set. (It's just random speculation-- don't sue me!)

[leftchick]

3. I am astounded daily at how they try to kill us....

The Drugs......

~snip~
_Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it. "I don't think Meridia passes that test," Graham said.


_Crestor, an anti-cholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor. Two of three other statin competitors prevent heart attack and stroke and do not cause renal failure, he said.


_Accutane, an acne drug linked to birth defects. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.


_Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.


_Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma. GlaxoSmithKline, told by the FDA to do a large, clinical trial, begged off. "We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."

[Just Me]

41. By the time human beings acknowledge the "profits over people" value,...

,...pursued by their "elected leaders",...they will be dead,...sparing the courageous few true visionaries for humanity.

[OhioChick]

5. I Understand

that REP. BART STUPAK's (D) MICHIGAN....Son...Bart, Jr. -- died on May 14th, 2000. He shot himself. He was only 17 years old and his Father has blamed his death on the use of Accutane.

[YellowDoginthehouse]

6. Advice...

If it's been on the market less than 10 years, don't take it.

If you don't have to take it, don't. Use natural remedies instead. Take aspirin or ibuprofen for pain. Do not take tylenol.

You have no idea how many side effects there are of drugs-like antibiotics-that are given every day. You also have no idea how many sick visits to the doctor are actually about medication side effects-though the doc will never tell you that.

I give medications every day that I would never dream of taking myself because I know too much about the drugs.

[bobbieinok]

21. what's the problem with tylenol???????...some links????

[OhioChick]

22. Mostly Liver Woes....

http://www.cnn.com/2004/HEALTH/01/23/painkiller.risks.ap/

[AllyCat]

29. Working on an ambulance...

...cannot tell you how often we see Tylenol ODs, either intentional or accidental. It causes an irreversible liver damage without having to take much either. There is a short window of opportunity and I have spent some time passing nasogastric tubes into people and pumping in activated charcoal to try to stop acetominophen poisoning.

It's not pretty. I've always though Tylenol was nearly useless as an analgesic and really only shows promise in reducing fever. In most cases, you do NOT want to reduce fever!! It's how your body fights infection! Unless the fever is high or has lasted a few days, leave it alone and let it run its course!

[YellowDoginthehouse]

32. Ally's right

Ally, have you ever figured out why anyone would try to commit suicide with it? The lethal dose on it must be tremendous. What people mostly wind up doing is frying their livers with it.

I have never been able to figure out its popularity as an instrument of suicide.

[AllyCat]

39. Cheap and easy.

It doesn't take much to overdose on it. You actually DON'T have to take a tremendous amount. Dying of liver failure really sounds pretty miserable to me. It causes irreversible liver damage and there is a narrow window of opportunity to administer an andidote. It has to be in the system long enough to have reached it's peak effect (3-5 hours), but not so long that it destroys the liver completely (same dose about 8 hours). Even with this window-administered antidote, the survivor's hepatic function is certainly sub-par for the rest of his or her life.

[YellowDoginthehouse]

31. Tylenol is hell on your liver. Look it up.n/t

[YellowDoginthehouse]

33. Mainstream medicine is a racket.

The sooner you learn that, the better off you'll be. Use a healthy dose of common sense when it comes to dealing with mainstream medicine. If you're sick, you have to go, and if you have a chronic condition like diabetes, you have to go-but otherwise, common sense should rule.

My sister (also a RN, also takes nothing but aspirin or ibuprofen)cracked a sardonic joke the other day about oncology clinics diluting chemotherapy drugs to half their intended strength, so that the patient has to come for more treatments-so the clinic can make more money. She swore this was the truth.

I related this crack to a colleague who is a certified oncology nurse-and she said that this was indeed true, and it happens everyday.

One of the main reasons that nurses leave nursing is because it doesn't take but about 10 years to realize that medicine as we practice it is a crock.

[YellowDoginthehouse]

34. Sorry, here's another example:

Why would a doctor prescribe Nexium when Pepcid works just as well? And is much cheaper? Sometimes these docs own stock in the company that makes the medication...sometimes they get kickbacks?

Why does anyone prescribe Neurontin for pain? It doesn't work for pain, has been shown not to work repeatedly, just from my experience in giving it, it doesns't work-so why is Medicare paying for it when prescribed for pain? It's expensive and it doesn't work. The company I work for recently dropped it from their formulary because it's been shown that it doesn't work.

I could go on and on...

[dreamcollector]

7. Another scandal is FDA approval of Aspartame

After Reagan became president Rummy had the head of the FDA fired and replaced by someone who would approve aspartame. Rummy made ten million on the deal. Aspartame is deadly and is causing blindness, cancer, MS, autism, Alzheimers, lupus, heart disease. See <www.dorway.com>
Avoid diet drinks and nutrasweet and stuff like that. Approval of aspartame is the biggest scandal of all. It is partially responsible for the epidemic of obesity too. Don't believe aspartame is safe. It is poison! Check labels. They even put it in kids vitamins. Sugarless gum is very bad. Check it out. But don't tell Dubya. I'm hoping it'll kill him. Truly. It would be nemesis. It is also addictive. Prior to Rummy the FDA was ethical.

[Name removed]

8. Deleted message

Message removed by moderator. Click here to review the message board rules.

[txindy]

19. It's the cartoon, isn't it?

The one the cartoonist was fired over at the Washington Post. What's wrong? He didn't get your best side there at the blackboard? He captured your mental capacity rather well, though.

[Name removed]

20. Deleted message

Message removed by moderator. Click here to review the message board rules.

[Straight Shooter]

25. Unfortunately for those of us on DU

they have not yet found a drug to cure stupidity, or for people who are obsessed with the dimensions of other people's genitals.

Ignorance. It's not just for inbreds anymore.

[xpunkisneatx]

27. this is bogus

This is all tin foil hat theories. People with PKU cannot have aspartame, but for anyone else it is fine.

[Lindacooks]

30. No, it isn't bogus.

This is exactly what I heard in 1980 and 1981 in Food Science classes at the University of Minnesota. Profs were certain aspartame would never be approved because there were so many problems with it. Reagan gets in, and BOOM! it's approved via Rummy, as the poster above said.

I wouldn't touch that crap with a ten foot pole.

[YellowDoginthehouse]

35. NEVER, ever consume aspartame.

It's often hidden in foods, read labels.

I quit drinking diet drinks a couple of years ago after I received an email about the effects of aspartame on memory. I had been having exactly the problems that the email described, and it was a small thing to drink water instead as an experiment.

The email was correct. I never went back to aspartame. I drink Diet RC or Dietrite instead.

[Guaranteed]

9. Accutane is VERY BAD.

It gives people severe emotional problems. Don't EVER take that stuff- seriously, folks. It'll make you go nuts.

[Name removed]

11. Deleted message

Message removed by moderator. Click here to review the message board rules.

[OhioChick]

12. Do Us ALL a Favor.....

See your doctor for a prescription, if you haven't already.

[DieDiebold]

14. I live in Canada.... It'll be a while before I get it, but I will try it.

[txindy]

15. Here today

Gone tomorrow. :hi:

[Dogmudgeon]

13. Yeah, like post #8 -- the John Kerry Sex Fantasy

:evilgrin:

--bkl

[Name removed]

16. Deleted message

Message removed by moderator. Click here to review the message board rules.

[txindy]

18. We could talk about B*sh

But it would be insulting to the animals he's so fond of, don't you think?

[Fovea]

17. Look Up!

That speck up in the sky, getting bigger.
It is a tombstone, and it is dropping on your least used extremity, your head.

[kuozzman]

10. Have any of you ever watched testimony on prescription drugs?

It's absolutely pathetic! Anybody who saw it today knows that. A couple months ago, I watched testimony on depression drugs for people under 18 and I couldn't believe what I was seeing! Not only was it obvious that they knew it increased the risk of suicide, but they basically admitted that the drugs weren't even effective!! That point, not surprisingly, was basically ignored, since the hearings were about suicide. Another thing I learned was the more than half of the prescription drugs people use AREN'T EVEN FDA APPROVED!! WTF?

[zulchzulu]

23. Check out their super-neato Flash-enhanced web sites

Meridia - http://www.meridia.net/ Abbot Labs

Crestor - http://www.crestor.com/ Astra Zenaca

Accutane - http://www.rocheusa.com/products/accutane/ Roche

Bextra - http://www.bextra.com/ Pfizer

Serevent - http://www.serevent.com/ GlaxoSmithKline

Such purty sites... (I used to do this healthcare advertising shit)

[Danmel]

36. Ad Blitz lately for Crestor

They've been advertising Crestor like crazy lately. I am so wary of these direct to patient ads. I really try to avoid taking anything unless it is really necessary. And I mean REALLY necessary. I just don't trust the pharmaceutical companies.

I seem to recall some concern about dependency with Meridia and Accutane has long been known to cause serious problems.

What are Canada's policies towards these drugs, since according to * Canadian drugs are so dangerous!

[RebelOne]

37. My next-door neighbor was taking Vioxx.

She died of a heart attack at 54.

[American Tragedy]

38. Dammit, my mom takes Crestor!

Why the hell did they prescribe her that statin when there are others that at the very least are not as controversial?

[McDiggy]

40. ........

Most of the stuff that this guy is talking about we already know.

Like the Vioxx thing, just a month ago in my pharmacology class the professor showed us a slide from a 1999 lecture where they said that a selective COX-2 inhibitor (Celexa, Vioxx, Bextra, etc.) could cause cardial events due to their effects on prostoglandins. It wasn't a shock that Vioxx turns out to be somewhat dangerous. In fact, many people took a 'told you so' stance. It's just that it was decided by the FDA that it was safe (and it actually is relatively safe from an incidence of adverse effects stance.)

Most of the blame should be put on the FDA for letting the drugs pass trials. God knows a faceless pharmaceutical company aren't going to care about anything but profits (the 'business' end of it anyway, the researchers genuinely care.) It's the FDAs job to make sure the bastards don't release something too soon before it's safety/efficacy is totally known.

[lil-petunia]

42. in dangerous Europe, they re-evaluate drugs every five years.

we never do.
Ergo, our drugs are safer than euro-drugs?

freeper logic, in place at the FDA.

Merck killed 26,000, with several hundred thousand suffering heart attacks or strokes.
Al Qaida killed 3,000 plus.
Bush will push legislation preventing lawsuits against drug companies sometime this term.

Who is our real enemy?