Side Effects of balsalazide: A Synthesis of Findings from 17 Studies

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Original Abstract of the Article

Major Research Findings

Balsalazide is a medication used to treat ulcerative colitis, an inflammatory bowel disease. 8 demonstrated that low-dose balsalazide combined with a high-potency probiotic preparation was more effective than balsalazide alone or mesalazine in treating acute mild-to-moderate ulcerative colitis. In another study, 14 found balsalazide to be an effective treatment for ulcerative colitis when used as monotherapy, compared to sulfasalazine. However, a case report from 2 highlights a rare case of a patient with ulcerative colitis experiencing limited form granulomatosis with polyangiitis and bronchiolitis obliterans organizing pneumonia-like variant after taking balsalazide. This case demonstrates the potential for balsalazide to have an impact on the lungs.

Reasons for Side Effects

The side effects of balsalazide are primarily attributed to the active ingredient 5-aminosalicylic acid (5-ASA). 5-ASA works locally in the intestinal tract to reduce inflammation. While effective, it can cause side effects in some patients, including digestive issues and allergic reactions. 1 reported a case of febrile pleuropericarditis as a side effect of balsalazide, likely caused by hypersensitivity to 5-ASA. Additionally, 4 suggests a correlation between higher doses of 5-ASA and increased digestive side effects, possibly due to excessive stimulation of the intestinal tract.

Common Side Effects

Gastrointestinal

Digestive issues are the most common side effects associated with balsalazide. documented diarrhea, abdominal pain, nausea, and vomiting as side effects. 6 points out that higher doses of 5-ASA formulations can lead to more digestive issues due to excessive intestinal stimulation. 4 reinforces this observation, indicating that increased balsalazide doses correlate with more frequent digestive side effects. 5 highlights that sulfasalazine tends to have more side effects compared to olsalazine, balsalazide, and mesalazine formulations.

Allergic Reactions

Balsalazide can trigger allergic reactions. 1 mentioned febrile pleuropericarditis as a possible side effect, likely caused by a hypersensitivity response to 5-ASA. reported rash, hives, and itching as potential side effects. 13 cautions that balsalazide and other 5-ASA medications can rarely cause severe side effects.

Other

Balsalazide can cause side effects beyond digestive and allergic reactions. 13 suggests that balsalazide and other 5-ASA drugs may rarely lead to liver and kidney dysfunction. 1 reports febrile pleuropericarditis as a possible side effect, likely due to 5-ASA hypersensitivity.

Side Effect Management

Gastrointestinal

Dietary adjustments and lifestyle modifications can help manage digestive side effects associated with balsalazide. 4 notes that higher 5-ASA doses can lead to increased digestive issues due to excessive intestinal stimulation. If digestive side effects are a concern, it's essential to consult a doctor and consider adjustments such as dose reduction.

Allergic Reactions

If an allergic reaction occurs after taking balsalazide, immediate medical attention is crucial. 13 warns that balsalazide and other 5-ASA medications can rarely cause serious side effects. Prompt medical care is essential to address any allergic reactions.

Comparison Between Studies

Commonalities Between Studies

Multiple studies have concluded that balsalazide is an effective treatment for ulcerative colitis. 8 and 14 showed that balsalazide outperformed other medications. Additionally, balsalazide has been reported to cause fewer side effects compared to other 5-ASA medications. 15 suggested that balsalazide has better patient tolerance than sulfasalazine. indicated that many patients who experienced allergic reactions to sulfasalazine were able to tolerate balsalazide. 11 found that balsalazide has fewer side effects than sulfasalazine and is effective in maintaining remission of ulcerative colitis.

Differences Between Studies

While multiple studies support balsalazide's effectiveness in treating ulcerative colitis, some differences in its effects and side effects have been observed. 8 found that low-dose balsalazide combined with a high-potency probiotic was more effective than balsalazide alone or mesalazine. Conversely, 14 found that balsalazide was effective as monotherapy compared to sulfasalazine. 2 reported a rare case of balsalazide-induced limited form granulomatosis with polyangiitis and bronchiolitis obliterans organizing pneumonia-like variant in a patient with ulcerative colitis. While uncommon, this case suggests that balsalazide can have an impact on the lungs.

Cautions for Real-World Application

While balsalazide is an effective treatment for ulcerative colitis, it is essential to understand its potential for side effects. 13 highlights that balsalazide and other 5-ASA medications can rarely cause severe side effects. It is crucial to adhere to your doctor's instructions, follow the correct dosage, and seek immediate medical advice if any abnormalities arise while taking balsalazide.

Current Research Limitations

The side effects of balsalazide haven't been fully elucidated. 2 reported a rare case of balsalazide-induced limited form granulomatosis with polyangiitis and bronchiolitis obliterans organizing pneumonia-like variant in a patient with ulcerative colitis. This case suggests the potential for balsalazide to affect the lungs, but more research is necessary to understand its long-term effects.

Future Research Directions

To further investigate the side effects of balsalazide, additional research is needed in the following areas:

  • Studies on the incidence and severity of side effects associated with long-term balsalazide use
  • Research on the correlation between balsalazide side effects and genetic polymorphisms
  • Development of new therapies to minimize balsalazide side effects

Conclusion

Balsalazide is an effective treatment for ulcerative colitis. However, it is crucial to be aware of its potential side effects and to follow your doctor's instructions carefully when taking this medication. As the understanding of balsalazide's side effects is still incomplete, further research is needed to gain a more comprehensive understanding of its long-term effects.

Literature analysis of 17 papers
Positive Content
16
Neutral Content
0
Negative Content
1
Article Type
4
0
0
8
17
1.

Febrile pleuropericarditis, a potentially life-threatening adverse event of balsalazide--case report and literature review of the side effects of 5-aminosalicylates.

Author: ComanRoxana M, GloverSarah C, GjymishkaAltin

Ulcerative colitis treatment
Myocarditis
Pericarditis
Pneumonitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease. While 5-aminosalicylates (5-ASAs) are effective treatments for UC, they can cause rare but potentially serious side effects, including inflammation of the heart and lungs. This report describes a case of pericarditis and pleuropericarditis in a patient taking balsalazide, a 5-ASA drug.

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.
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.

A Case of Balsalazide-Induced Limited Form of Granulomatosis with Polyangiitis with Bronchiolitis Obliterans Organizing Pneumonia-like Variant in Ulcerative Colitis.

Author: KangShin Myung, JangYoung Rock, YoonHyun-Hwa, KimSuji, KimEun Young, HaSeung Yeon, ParkJeong-Woong

Pulmonary complications

This case report describes a patient with ulcerative colitis on balsalazide who developed a limited form of granulomatosis with polyangiitis, highlighting a rare side effect of this medication.

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

Language : English

3.

Balsalazide and/or high-potency probiotic mixture (VSL#3) in maintaining remission after attack of acute, uncomplicated diverticulitis of the colon.

Author: TursiAntonio, BrandimarteGiovanni, GiorgettiGian Marco, EliseiWalter, AielloFabio

Diverticulitis prevention

A combination of probiotics and an anti-inflammatory drug was found to be more effective in preventing relapse of uncomplicated diverticulitis of the colon than probiotics alone. This pilot study, involving 30 patients with diverticulitis, showed that the combination therapy resulted in a lower relapse rate compared to the probiotic group, although the difference was not statistically significant.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Colonic targeting of aminosalicylates for the treatment of ulcerative colitis.

Author: KlotzU

Ulcerative colitis treatment
Side effects

This article reviewed the use of aminosalicylates (5-aminosalicylic acid) for the treatment of ulcerative colitis. Aminosalicylates are the drugs of first choice for this condition, and they can be delivered to the colon via inactive azo-prodrugs or special galenic formulations. The article discussed the different therapeutic approaches and their efficacy and side effects.

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

8.

Low-dose balsalazide plus a high-potency probiotic preparation is more effective than balsalazide alone or mesalazine in the treatment of acute mild-to-moderate ulcerative colitis.

Author: TursiAntonio, BrandimarteGiovanni, GiorgettiGian Marco, FortiGiacomo, ModeoMaria Ester, GigliobiancoAndrea

Effective in ulcerative colitis

Balsalazide and VSL#3 are effective treatments for ulcerative colitis. A study compared the effectiveness of balsalazide and VSL#3 to that of mesalazine in treating mild to moderate ulcerative colitis.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

5-Aminosalicylic acid derivatives. Clinical and pharmaceutical evaluation.

Author: ChristensenL A, JacobsenB A

CIBD treatment
Fewer side effects

New 5-aminosalicylic acid (5-ASA) derivatives, such as Balsalazide and Dipentum, are as effective as salazosulphapyridine (SASP) in treating ulcerative colitis with fewer side effects. Controlled-release preparations are promising for maintaining remission and treating mild to moderate flares in ulcerative colitis.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Balsalazide in the maintenance treatment of patients with ulcerative colitis, a double-blind comparison with sulphasalazine.

Author: McIntyreP B, RodriguesC A, Lennard-JonesJ E, BarrisonI G, WalkerJ G, BaronJ H, ThorntonP C

Improved haemoglobin
Reduced side effects
Diarrhoea
Rash

Balsalazide and sulphasalazine were equally effective in maintaining remission in patients with ulcerative colitis. Balsalazide had fewer side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

12.

Studies of two novel sulfasalazine analogs, ipsalazide and balsalazide.

Author: ChanR P, PopeD J, GilbertA P, SacraP J, BaronJ H, Lennard-JonesJ E

Low oral toxicity

Ipsalazide and balsalazide are novel sulfasalazine analogs designed to release 5-aminosalicylic acid in the colon, offering potential benefits over sulfasalazine. These analogs have low oral toxicity and deserve further therapeutic trials.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.

Language : English

13.

New developments in the treatment of inflammatory bowel disease.

Author: MutluEce A, FarhadiAshkan, KeshavarzianAli

IBD treatment

This review discussed emerging changes in the treatment of inflammatory bowel disease (IBD). The review discussed improvements in conventional IBD medications, as well as newly introduced drugs such as mycophenolate mofetil (MMF), thalidomide, and heparin. The review also discussed emerging biological therapies, such as therapies against TNF and anti-oxidant therapies.

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

14.

A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis.

Author: MansfieldJ C, GiafferM H, CannP A, McKennaD, ThorntonP C, HoldsworthC D

Better tolerated than sulfasalazine
Effective ulcerative colitis treatment
Intolerance
Side effects

Balsalazide was effective as the sole treatment for patients with mild to moderately active ulcerative colitis, with significantly fewer withdrawals due to side-effects than in a similar group of patients taking sulfasalazine.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Review article: balsalazide therapy in ulcerative colitis.

Author: RagunathK, WilliamsJ G

Improved ulcerative colitis remission
Reduced side effects

Balsalazide, a 5-aminosalicylic acid (mesalazine) pro-drug, induced symptomatic and complete remission of acute ulcerative colitis in a greater proportion of patients than mesalazine at equivalent doses.

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

16.

Arylamine N-acetyltransferases: from drug metabolism and pharmacogenetics to drug discovery.

Author: SimE, AbuhammadA, RyanA

Anti-tuberculosis therapy
Breast cancer biomarker detection
Cancer therapy

Arylamine N-acetyltransferases (NATs) are polymorphic enzymes involved in drug metabolism. This article discusses their role in drug metabolism, substrate specificity, and potential implications for drug development and cancer therapy.

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

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