Constipation Drug Linked With Heart Risks

Zelnorm Sales Halted After FDA Finds Increased Risk Of Heart Attack And Strokes

(AP)  Swiss pharmaceutical maker Novartis AG will stop selling a drug to relieve constipation after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack, federal health officials said Friday.

Novartis agreed to withdraw Zelnorm at the FDA's request, the agency said in a public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Doctors who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate, the FDA added.

Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

FDA officials described the cardiovascular side effects as "a very rare event." Still, "we concluded the benefits of this drug no longer outweighed the risks for patients," said Dr. John K. Jenkins, director of the FDA's Office of New Drugs.

The FDA has told Novartis it would consider allowing a limited reintroduction of Zelnorm "if a population of patients can be identified in whom the benefits of the drug outweigh the risks," the agency said.

Novartis said it believes the drug provides unique benefits.

"Although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients," said Dr. Stephen Cunningham, vice president and head of U.S. clinical development and medical affairs for Novartis.

The FDA first approved Zelnorm in 2002. The agency did not have data concerning how often it's prescribed in the U.S.

Jenkins said that Novartis first informed the FDA on Feb. 22 about the data it had accumulated. The agency asked for more information for a review. On Wednesday, FDA asked the company to discontinue marketing the drug. The company agreed to do so on Thursday.

[donnat68]

Im a 40 year old who was just released from the hospital after having an acute MI(heart attack). I am so completely baffled at having this happen to me and researching some possible causes since I am maybe 5 lbs. overweight, have normal cholesterol counts, low blood pressure, excercise, take Omega 3's...not your usual 40 year old heart attack victim....I did use Zelnorm however and did think it was an excellent drug...however now I dont know....my only other idea is that I also was a heavy Ibuprofen user which is also proving to be a risk...I am an RN and I am baffled...

[sholdren]

Get a grip, folks. Those of you who take Zelnorm need to work with your doctors. You'll probably still be able to get it IF you're willing to sign something that says you know it can cause heart attacks and strokes, you understand all of this, and you choose to accept those risks.

Those of you who are hating on the FDA and Novartis -- get a grip too. Nobody is perfect. Maybe this particular drug has some nasty side effects, but unless you've had the condition and gotten the relief that Zelnorm has offered millions of people, lighten up. No one is making YOU take it, or any of the dozens of other drugs regulated by the FDA -- like antibiotics for your strep infections, or blood pressure medications, or cardiac medications, or cholesterol meds, etc., etc. Get over yourselves.

[leidhold]

THE FDA IS A JOKE!!!!

THESE GUYS THAT HAVE BEEN RUNNING THE FDA KEEP GETTING BOOTED.

LOOK AT THEIR LAST GUYS WHO RAN THE FDA.

HAVEN'T THE LAST 3-4 BEEN BOOTED?!?!?!?

HAHAHHAHA.....

DR's AND YOUR LOCAL PHARMACIST DON"T EVEN TALK TO EACH OTHER ABOUT MEDS... WHO IS FILLING YOUR MEDS AT YOUR LOCAL PHRAMACY???? SOME 18 year old...

HAHA...

THE MEDICAL COMMUNITY IS A JOKE. THE FDA AND THE AMA, ACOG ARE EVIL!!!!

LEIDHOLD...

MY OPINION ALWAYS...

[leidhold]

MEDS KILL.....

IN MY OPINION, NOVARTIS EXECS ARE KILLERS.

THEY SELL THIS MED AND TEGRETOL....

IT RIPPED MY BLADDER APART AND HAS GIVEN ME CHRONIC URINE PROBLEMS WITH SPASMS THAT DON"T QUIT.

THOSE EXECS SELLING THESE MEDS OUGHT TO JAILED, IN MY OPINION!!!

LEIDHOLD

ALWAYS MY OPINION!!!

[bmsbms29]

For those who have found this and only this drug to be helpful - PLEASE see a nutritionist!

I keep finding more & more drugs that cause problems - even minor ones.

Good luck! and Best Wishes

[charliesok]

All I can say is, *** *** ***. I too had experienced chest pain that could have been a result of my cardio workouts. In any event the relief that ZELNORM brought mad a difference in my life these past 2 years. I have battled w/ an inabilty to have a bowel movement despite my feeling the need to go for the past 20 years. Zelnorm made me feel a sense of relief I had forgotten about. Suffering returns to those of us who thought we had a fix. So Sorry...

[drinuk]

Angelgirls2, Buy yourself a bottle of Californian Syrup of Figs, start eating a proper diet, leave the junk foods alone, do not digest anything containing Aspartame, including diet coke and go check your local health food store for vitamins and minerals. You could throw away your fying pan.

[drinuk]

Another load of Big Pharma junk allowed by the FDA without Independent research. How many times have the FDA approved poisons on the say so of the manufacturers. It is not acceptable to use patients as guinea pigs, pulling the drug only after people have suffered serious side effects.
This sort of behaviour is far too frequent and leaves many questions un-answered, like just who is signing this stuff off and why?

[angelgirls2]

I to use this for severe stomach pain because I can not go to the bath room, but I have had the side effect of on and off chest pain so bad that I thought I was having a heart attack! So I guess I will stop taking this for me and my kids because I don't need to have a heart attack at 27 yrs old! But I wish that they would come up with another drug just as good soon because this pain is going to come back like a ton of bricks!!

[jules51561]

My son has Gastroparesis caused by Encephalitis. Zelnorm is the only thing that has stopped him from vommiting daily. He lost 30 pounds in a very short period of time from not being able to keep anything down and the Zelnorm has made a big difference. I wish they would do more extensive testing as this is the only thing he can take. The only other drug is Reaglan and he had a bad reaction to it.

[hardrock18]

Zelnorm provided relief for my wife, the very fisrt time she began using it. She suffers from a very painful condition called gastroparesis. And, she is not a diabetic, as most gastroperosis sufferers are. After repeatedly writhing on the floor in excruciating pain after trying to eat, and losing 24 pounds, she was able to use Zelnorm along with other medications to improve the quality of her life and to once again have a somewhat normal workday. Those who make generalities from the soapbox of ignorance need to do a little thinking and some independent research. Start with the math....divide 11 by 13,614. The result is insignifcant compared to the success for the 13,614. Then ask the question: What other cadiovascular problems these 11 might have had. What maladies were the 11 suffering from. The FDA is being cowardly and bureaucratic. All meds have side effects and your physician, working with a pharmacist, is the best decision maker. And, as for the writer saying take prune juice and fiber...do your homework. Those suffering from gastroparesis can not have either.

[gaye5]

aokuley my husband suffered exactly the same, and we thought it was the stress of being a school Principal, eventually he found a good homeopathic and he has never looked back, when it stops working she changes him onto something else and it works again, dont ask me how and I thought it as all hockis pokis but it does, then he found that if he stopped eating anything with gluten in it that it was also helped, no bloating, no pain.. plus dont use toothpaste, something in it makes some people feel so sick etc
..........................
carying on from my last post..
natural therapist have been able to cure sickness that dr's have given up on, then they have the cheek to regulate the natural products.

If natural products are as bad as they try to tell us that they are, then why are there not many thousands of deaths, yes I have no doubt that some people have troubles just as they would from some foods.. Natural medicines have been forced by governments (via pharmaceutical companies,) to lower their amounts so much that they are not much good which is perhaps what the pharmaceutical companies want us to feel, so as we will turn to drugs again.. dont get me wrong, medicine used to be an honourable profession, and still is for some Drs but who they get their drugs off are only interested in profits... in the past they have experimented on orphans and the intellectually handicapped, so why would they care about us.. look on the net...

[gaye5]

Prescribed drugs kill 106,000 people in a year and cause 2,216,000 to be hospitalized %u2013 Journal American Medical association (JAMA) April 15 1998.



Drug reactions are now the fourth major cause of death after heart disease, cancer and stoke - Journal American medical Association (JAMA) 1998; 279: 1200.



Over one million Britons end up in hospital each year due to bad reaction to prescribed drugs or medical error %u2013 Dr V Coleman, The Betrayal of Trust, EMJ, 1994.

Only one in 24,000 adverse drug reactions is ever reported %u2013 British Journal of Clinical Pharmacology 1997; 43: 177-181.

The American Medical Association (AMA) is a nonprofit agency whose mission is "to be an essential part of the professional life of every physician and an essential force for progress in improving the nation's health," according to the AMA's website. It makes you wonder, then, why the AMA gladly accepted huge sums of advertising fees from tobacco companies who advertised heavily in its flagship journal, JAMA, throughout the 20th century.

Forced Chemotherapy, Drugging and Vaccination of Children - Murder by Court Order
Medical Fascism in the USA, Australia and the UK
Courts Order Kids To Take Drugs - Parents pressured to put kids on AZT, Ritalin, and other dangerous toxic drugs. Judges can constitutionally order controversial chemotherapy and drugs to be given to a child over the opposition of his parents.

[aokuley]

I agree with the one who said this sucks. I have found Zelnorm to be the only help for irritable bowel. So what are we to do, I suffered with bad abdomen pain after I ate even the smallest meal, After I started taking Zelnorm I no longer had the gas and bloating,days of constipation. Why not let us decide if we want to continue taking it.
I took all sorts of stuff and nothing worked for me.
This is like taking blood pressure medicine away from people who need it to control their blood pressure. I would like to see the FDA suffer from our symtoms!!

[aokuley]

I agree with the one who said this sucks. I have found Zelnorm to be the only help for irritable bowel. So what are we to do, I suffered with bad abdomen pain after I ate even the smallest meal, After I started taking Zelnorm I no longer had the gas and bloating,days of constipation. Why not let us decide if we want to continue taking it.
I took all sorts of stuff and nothing worked for me.
This is like taking blood pressure medicine away from people who need it to control their blood pressure. I would like to see the FDA suffer from our symtoms!!

[telsrt-2009]

Yet another drug on the market that wasn't properly tested by the FDA.
I have to live with the FDA's decision to market drugs without knowing all the side effects every day and now my family is going to have to wonder yet again what kind of damage Zelnorm may have caused to my oldest son and his wife.
The rush to get new drugs on the market MUST be done in a more professional way, I would have filed suit against the FDA over a top selling chloesterol drug that was pulled from the market if I could have!
I was told that the FDA could not be held liable over their decisions to approve drugs, I guess this is one reason they don't investigate drugs any better than they do!

[aokuley]

I agree with the one who said this sucks. I have found Zelnorm to be the only help for irritable bowel. So what are we to do, I suffered with bad abdomen pain after I ate even the smallest meal, After I started taking Zelnorm I no longer had the gas and bloating,days of constipation. Why not let us decide if we want to continue taking it.
I took all sorts of stuff and nothing worked for me.
This is like taking blood pressure medicine away from people who need it to control their blood pressure. I would like to see the FDA suffer from our symtoms!!

[aokuley]

I agree with the one who said this sucks. I have found Zelnorm to be the only help for irritable bowel. So what are we to do, I suffered with bad abdomen pain after I ate even the smallest meal, After I started taking Zelnorm I no longer had the gas and bloating,days of constipation. Why not let us decide if we want to continue taking it.
I took all sorts of stuff and nothing worked for me.
This is like taking blood pressure medicine away from people who need it to control their blood pressure. I would like to see the FDA suffer from our symtoms!!

[gaye5]

Firstly, stay off any milk products, it constipates especially coffee with boiled milk, get a fibre product from the health shop, and take two tsps a day, drink lots of milk and if all else fails have a small bottle of prune juice,, that works wonders... nothing used to work for me, and I mean nothing!!! but prune juice sure does...or two tsps of magnesium...
We are told that all pharmaceutical products are tested, hmmmmm and even though natural products have been used for centuries, hundreds of years longer than pharmaceutical drugs, we are constantly told that we shouldn't take natural products as they are not tested thus the odd person gets sick or even die, hmmmm YET...
Prescribed drugs kill 106,000 people in a year and cause 2,216,000 to be hospitalized %u2013 Journal American Medical association (JAMA) April 15 1998.

[elgraz]

The FDA is playing its usual games and in this case is full of excrement..........the dog kind.