zelnorm

[Guest guest]

hello everyone,

i recived a letter yesterday from Vanderbilt University Medical Center that the

drug zelnorm has been asked by the FDA for a voluntary removal from the market

as a very seriuos side effect has been discovered: angina, serious chest pains,

and potential heart problems, i have been on zelnorm for almost 2 years and have

experienced the severe chest pain not quite enough to go to hosp but enough to

wake donnie up at 3am and have him sit with me until it subsided, not long ago i

got into the wonderful 'loop or blackhole' of medciare part d where they have

paid their 2250$ maximum and i now have to pay until i max out at $3600, so i

chose to stop zelnorm as it is almost $200 for one months supply, i was going to

take a break from this med until i topped out my doctor suggested taking breaks

from it, and then only pay $10 tops copays,well i noticed my chest pains were

gone donnie and i thought maybe i was devloping acid reflux but i have had zero

symptom since stopping zelnorm. i wanted to share this, hugs, sharon

below is a copy of the article included in my letter from Vanderbilt.

Home » Articles

FDA Asks Novartis to Suspend Marketing of GI Drug Zelnorm

Apr 2, 2007 | NewsInferno.com

The U.S. Food and Drug Administration (FDA) notified Novartis Pharmaceuticals

Corporation that the company must cease its marketing of Zelnorm (tegaserod), a

prescription drug used in the treatment of constipation and irritable bowel

syndrome (IBS). According to the FDA, Zelmorm has been associated with an

“increased risk of serious cardiovascular adverse events (heart problems).â€

Novartis has agreed to voluntarily suspend its marketing of Zelnorm.

Zelnorm was first approved by the FDA in 2002 to treat constipated women with

IBS, and the approval was expanded two years later to treat chronic constipation

in both men and women younger than 65. However, recent randomized trials

conducted by Novartis have called into question the drug’s safety, and the FDA

now says that “for most patients the benefits of this drug no longer outweigh

the risks.†According to the data, “the risk of serious cardiovascular

adverse events (e.g., angina, heart attacks, and strokes) associated with use of

Zelnorm is higher than with placebo treatment.â€

“This decision reflects the FDA’s commitment to continuously monitor

approved drugs throughout their marketing life, and take action when we believe

the risks exceed the benefits,†said Dr. Throckmorton, deputy director

for the Center for Drug Evaluation and Research. “Here, a potential risk of

very serious harm to patients who have this non-life-threatening condition was

recently identified, making this action necessary.â€

The FDA recommends that Zelnorm patients who experience severe chest pain,

shortness of breath, dizziness, difficulty walking or talking, or other symptoms

of a heart attack or stroke should contact their doctors immediately.

--

I am daugher of Leonard, diagnosed May 2004, probably had lbd since 1993,.Dad

had a serious fall in 7/05 causing him to hav hip surgery .After that he

developed aspiration pneumonia 7/05 with pulmonary embolyis, which he almost

died from. He had a 2nd bout of aspiration pneumonia and uti 8/05. He died when

his blood pressure fluctuations started dropping without coming back up on

9/25/05,

may he rest in peace with his mom and dad,

a smile a day keeps the meanies away