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.