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IBS Books > First Year: IBS >  Chapters > Prescription Drugs

Day 6 - Living

Trying Prescription Drugs for Irritable Bowel Syndrome

Lotronex

Lotronex is a special case when it comes to IBS prescription drugs. Manufactured by GlaxoSmithKline, the FDA approved Lotronex in February 2000 after giving it an expedited, "fast track" review.[3] It was the first of a new generation of agents being studied specifically for the treatment of multiple symptoms of IBS, and it was meant to be prescribed only for women who were diarrhea-predominant.

In clinical terms, Lotronex was a potent and selective 5-HT3 antagonist. In brief, the neurotransmitter serotonin and 5-HT3 receptors that are extensively distributed on enteric neurons in the human GI tract are thought to play a role in increasing the sensation of pain and affecting bowel function in patients with IBS.

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While the precise mechanism of action of Lotronex was never fully understood, one hypothesis was that Lotronex blocks the action of serotonin at 5-HT3 receptor sites in the enteric nervous system, thus slowing colonic transit time and preventing IBS diarrhea-predominant symptoms.

In plain English, Lotronex somehow affected the action of serotonin (a neurotransmitter found in abundance in the gut), thus preventing painful cramps and slowing colon contractions to reduce diarrhea. For some patients, Lotronex was quite literally a wonder drug.

"After two weeks of taking Lotronex, I had my life back!"

Melissa D. Godwin, Parkersburg, West Virginia, age 27, IBS Sufferer for 8 years.

I have suffered from Irritable Bowel Syndrome for eight years now, and they have been the most miserable years of my life. The symptoms of IBS that I suffer from are: diarrhea, bowel cramping, severe gas, headaches, fatigue, muscle weakness, and sharp stabbing pains in my lower abdomen. Nearly every day, I feel physically and emotionally drained. IBS is not life threatening, but it is life prohibiting. It is difficult to go out to dinner with friends or family because all through dinner, I worry that what I just ate is going to make my bowels cramp. Or, if I go to a movie after dinner I have to sit in the aisle seat in case I have to run off to the rest room. Traveling is nearly impossible. What if I am in the car, nowhere near a rest area, and have that dreaded urgency and cramping? I generally have panic attacks by the time I get out of town. I not only have to be concerned with traveling and public places - this condition affects my job as well. I have tried diet modification, fiber, numerous over-the-counter medications, stress control, anti-depressants, anti-anxiety drugs, and anti-spasmodic medications just to stop the IBS pain. Of all these medications, only one worked.

Everything was solved by one little blue pill called Lotronex. After two weeks of taking Lotronex, I felt like a new person. I had my life back! I was able to go to public places and travel. I could eat and drink anything I wanted and I had no cramps, no urgency, and no gas pain. Those were the happiest months of my life! Then Lotronex was pulled off the market, and this was a tragedy to me. The loss of Lotronex led me to the Lotronex Action Group, and I decided to join their fight. I was so thankful they gave me the opportunity to tell my story, because without Lotronex, I feel like I'm right back where I was before."


For other patients, however, Lotronex was not a dream but a nightmare. While clinical trials of the drug showed few side effects, reports of serious and even deadly adverse reactions to the medication began cropping up shortly after its FDA approval. In some patients the drug caused side effects so severe they resulted in hospitalization and even death. Through the end of the year 2000, sixty-three patients taking Lotronex developed ischemic colitis, an interruption of the blood supply to the large intestine which results in severe internal damage. Seventy-five patients experienced severe constipation. Most of the patients who developed these problems required hospitalization. In all, the FDA has on record 141 cases of severe gastrointestinal complications in patients who took the drug, and five deaths.[4] As a result of these problems, Lotronex was pulled from the US market in November 2000, just nine months after it debuted.

In response, a group of IBS patients who had experienced great success with Lotronex formed the Lotronex Action Group, a non-profit patient group seeking renewed access to the drug.[5] The Lotronex Action Group believes Lotronex to be safe if dispensed properly, and that the benefits of Lotronex far outweigh the potential risk for adverse side effects. The LAG has urged the FDA not to lose sight of the patients, and to realize that the medical community has been slow to recognize IBS as a legitimate disorder that can have debilitating side affects. The LAG wants taken into account their concerns that efforts for reintroduction of the only effective treatment for some IBS patients suffering from severe diarrhea and abdominal pain will be derailed due to a lack of understanding of the severity of the symptoms IBS can cause. The LAG also maintains that although claims have been made that severe side effects have been linked to Lotronex, it appears that less than a fraction of 1% of the 300,000 people taking the drug were affected. Moreover, the LAG contends that no data has been released proving that those who suffered from side effects were ever properly diagnosed with IBS and were also good candidates for Lotronex in the first place.

The Lotronex Action Group has lobbied the FDA for immediate re-release of Lotronex while avenues for continued marketing are explored between the manufacturer, GlaxoSmithKline, and the Food and Drug Administration. Moreover, the LAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with diarrhea- predominant IBS.

In response to the pressure from both the pharmaceutical industry and the Lotronex Action Group, the FDA is, as of mid-2001, considering putting Lotronex back on the market. However, any re-introduction may be limited to patients who have previously used it and have not experienced adverse effects, and who have been given an informed consent sheet explaining the potential dangers of the drug. In addition, a registry of all patients taking the drug and their physicians would be kept so the patients can be closely monitored. In the view of Public Citizen, "If anything other than this approach is used, the toll of needless deaths and serious injuries and the repeat ban that will inevitably occur will be on the hands of those FDA officials responsible for such a reckless remarketing."[6]

If nothing else, the Lotronex debacle points up the gaping chasm that remains between the medical needs of IBS patients and the limited drug choices currently available to them.

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[3] The U.S. Food and Drug Administration has reported that average approval time for all new prescription drugs has shrunk from 30 months eight years ago to 12 months today, with high-demand medicines racing to market in as little as 6 months. Years ago, when Europe took the lead in marketing new drugs, American regulators watched for side effects before approving drugs here. Now, the majority of new drugs worldwide debut in the United States. With this change comes serious risks, as ten drugs have been recalled in America for toxic effects since 1997.

[4] Public Citizen, Health Research Group. 1600 20th St. NW, Washington, DC. 20009, (202) 588-1000, www.publiccitizen.org.

[5] Lotronex Action Group, Tom Bell, Coordinator. Richard Fireman, Coordinator. Corey Miller, Coordinator. Jeffrey Roberts, Coordinator. The Lotronex Action Group was organized by members of the IBS Self Help Group and former Lotronex users. The Lotronex Action Group is not affiliated with, nor does it receive any funding from, any pharmaceutical company.

[6] Public Citizen, Health Research Group. 1600 20th St. NW, Washington, DC. 20009, (202) 588-1000, www.publiccitizen.org.


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