Side Effects of alosetron: A Synthesis of Findings from 11 Studies

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Original Abstract of the Article

Major Research Findings

Alosetron, a serotonin 3 receptor antagonist, was initially approved by the FDA for the treatment of diarrhea-predominant irritable bowel syndrome (IBS). 11 , 9 , 2 . It was found to be effective for diarrhea-predominant IBS, but with some potentially serious side effects. 9 . However, it has since been withdrawn from the market due to the occurrence of serious side effects such as constipation, fecal impaction, and ischemic colitis. 11 , 10 , 7 , 4 . These side effects are primarily linked to the drug's interaction with serotonin receptors in the gut, which control intestinal motility and blood flow. 11 , 10 , 5 .

Reasons for Side Effects

Alosetron is a serotonin 3 receptor antagonist. 9 . Serotonin plays a crucial role in regulating intestinal motility and secretion. 5 . When alosetron blocks serotonin 3 receptors, it inhibits intestinal motility, leading to constipation and fecal impaction. 11 , 10 . Additionally, it can disrupt intestinal blood flow, potentially causing ischemic colitis. 11 , 10 .

Common Side Effects

Constipation

Alosetron can lead to severe constipation. 11 , 10 . This is a direct consequence of alosetron's ability to suppress intestinal motility. 11 .

Fecal Impaction

Fecal impaction is another potential side effect of alosetron. 11 , 10 . This occurs when constipation worsens and becomes severe. 11 .

Ischemic Colitis

Alosetron is also associated with the risk of ischemic colitis. 11 , 10 . This condition arises due to restricted blood flow to the intestines, potentially caused by alosetron's impact on blood vessel function. 11 .

Countermeasures for Side Effects

Constipation

If you experience constipation while taking alosetron, discontinue use and consult your doctor promptly. 11 . You can also try incorporating more fiber into your diet and increasing your fluid intake to manage constipation symptoms. 11 .

Fecal Impaction

Seek immediate medical attention if you experience fecal impaction. 11 . Fecal impaction is often a complication of severe constipation, so prompt medical advice is crucial. 11 .

Ischemic Colitis

Seek immediate medical attention if you experience symptoms of ischemic colitis. 11 . Ischemic colitis is caused by inadequate blood flow to the intestines, so immediate treatment is essential. 11 .

Comparison between Studies

Commonalities between Studies

Several studies have consistently shown that alosetron poses a risk of side effects such as constipation, fecal impaction, and ischemic colitis. 11 , 10 , 7 , 4 .

Differences between Studies

Variations exist in the reported frequency and severity of alosetron side effects across different studies. 11 , 10 , 7 , 4 . These differences might be attributed to factors such as variations in study participants, study design, and methodologies. 11 , 10 , 7 , 4 .

Cautions for Real-World Applications

Alosetron has been withdrawn from the market and is no longer available. 7 , 4 . Therefore, it's crucial to exercise caution and be aware of its side effects based on the available research findings. 11 , 10 , 7 , 4 . If you experience symptoms that you suspect may be related to alosetron side effects, seek medical advice immediately. 11 .

Limitations of Current Research

There is still a need for more extensive research on alosetron side effects. 11 , 10 , 7 , 4 . In particular, our understanding of long-term side effects remains limited. 11 , 10 , 7 , 4 .

Future Research Directions

Further research into alosetron side effects is warranted. 11 , 10 , 7 , 4 . Specifically, in-depth investigations into long-term side effects and the impact of alosetron on the intestines are crucial. 11 , 10 , 7 , 4 .

Conclusion

Alosetron, while initially promising for women with severe diarrhea-predominant IBS, was associated with significant side effects, including constipation, fecal impaction, and ischemic colitis. 11 , 10 , 7 , 4 . Despite its withdrawal from the market, further research into its side effects remains essential. 11 , 10 , 7 , 4 . If you encounter symptoms that you suspect may be linked to alosetron side effects, seeking immediate medical attention is crucial. 11 .

Literature analysis of 11 papers
Positive Content
7
Neutral Content
1
Negative Content
3
Article Type
0
1
1
7
11
1.

Sex-Related Differences in Pharmacokinetics and Pharmacodynamics of Frequently Prescribed Drugs: A Review of the Literature.

Author: FarkouhAndré, RiedlThomas, GottardiRoman, CzejkaMartin, Kautzky-WillerAlexandra

Drug efficacy
Drug safety
Adverse effects

This study reviews the evidence of sex-related differences in drug metabolism, efficacy and safety of frequently prescribed drugs. Clinicians are encouraged to be aware of these differences and adjust dosages accordingly.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

2.

Using the incremental net benefit framework for quantitative benefit-risk analysis in regulatory decision-making--a case study of alosetron in irritable bowel syndrome.

Author: LyndLarry D, NajafzadehMehdi, ColleyLindsey, ByrneMichael F, WillanAndrew R, SculpherMark J, JohnsonF Reed, HauberA Brett

Alosetron for IBS
Benefit-risk assessment

This study evaluated the incremental net benefit (INB) framework for undertaking quantitative benefit-risk assessment by performing a quantitative benefit-risk analysis of alosetron for the treatment of irritable bowel syndrome from the patients' perspective.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

5-hydroxytryptamine and the gastrointestinal tract: where next?

Author: SangerGareth J

Treat IBS
Treat cancer
Treat constipation
Treat diarrhea
Treat dyspepsia
Treat gastroparesis

Drugs that modulate serotonin function in the gut have been successful in treating various disorders, but safety concerns with alosetron and tegaserod have highlighted the challenges in this field.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Balancing drug risk and benefit: toward refining the process of FDA decisions affecting patient care.

Author: SchillerLawrence R, JohnsonDavid A

Drug withdrawal

The FDA's process for approving and monitoring drugs for functional bowel disorders needs to be reevaluated.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Systematic review: the safety and tolerability of pharmacological agents for treatment of irritable bowel syndrome--a European perspective.

Author: HeadingR, BardhanK, HollerbachS, LanasA, FisherG

Well tolerated
Ischemic colitis
Severe constipation

There is a significant lack of data on the safety and tolerability of therapies currently used to treat irritable bowel syndrome (IBS) in Europe.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

7.

Drug withdrawals and the lessons within.

Author: SmithDennis A, SchmidEsther F

Drug withdrawal

This review classifies drugs withdrawn from the US market over the last 25 years by their reasons for withdrawal, and examines how drug discovery programs have been modified in response to these events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

9.

Psychotherapeutics and serotonin agonists and antagonists.

Author: MertzHoward

IBS treatment
Serious side effects

Current treatments for irritable bowel syndrome (IBS) include antidepressants, psychotherapy, and agents targeted at receptors in the enteric nervous system, such as alosetron and tegaserod.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Colonic toxicity of administered drugs and chemicals.

Author: CappellMitchell S

Colonic hypomotility
Colonic ischemia
Colonic pseudo-obstruction
Hemorrhagic colitis
Inflammatory colitis
Lymphocytic colitis
Neutropenic colitis
Pseudomembranous colitis
Toxic colitis
Yersinia enterocolitis

Medication-induced colonotoxicity, though uncommon, can be serious and requires prompt medication cessation. This review categorizes medications associated with colonotoxicity into various categories, including those associated with ischemia, pseudo-obstruction, colitis, and lymphocytic colitis.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Ischemic colitis during treatment with alosetron.

Author: FriedelD, ThomasR, FisherR S

Effective IBS treatment
Constipation
Ischemic colitis

This study describes a case of ischemic colitis in a patient with irritable bowel syndrome (IBS) who was treated with alosetron, a serotonin antagonist approved for diarrhea-predominant IBS. The colitis symptoms correlated temporally with alosetron use and resolved upon discontinuation of the drug. This case highlights the potential for severe side effects, including ischemic colitis, with alosetron use.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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