Laxative Product Offers a New Colonoscopy Prep Option
A new combination therapy cleanses the colon before this important procedure that screens for colorectal cancer, the third-leading cause of cancer-related deaths in the United States.
Colorectal cancer refers to an uncontrolled cell growth that starts in the lower region of the gastrointestinal tract, specifically in the colon and rectum.
Colorectal cancer often develops from abnormal growths or precancerous polyps in the walls of these organs. Over time, these polyps can invade nearby tissue and spread beyond this area.
The risk of developing colorectal cancer increases with age. Other nonmodifiable risk factors include genetic syndromes, such as familial adenomatous polyposis or Lynch syndrome, and a history of colorectal cancer or inflammatory bowel disease. Lifestyle and modifiable risk factors include alcohol consumption, a diet high in fats and processed meats and lower in fiber, obesity, physical inactivity, and tobacco use.1
Colorectal cancer is the third-leading cause of cancer-related deaths in the United States and the third-most-common cancer in both men and women. Each year, about 141,425 new cases of colon and rectal cancer are reported in the United States, with about 50,000 deaths. Most of the patients diagnosed are older than 50 years of age.
One of the best ways to reduce the risk of colorectal cancer is to screen for polyps.
Individuals between ages 50 and 75 years should get screened, according to the US Preventive Services Task Force, as most cases occur in those 50 years of age or older.2 There are several screening methods available, including a colonoscopy, a computed tomography colonography, a flexible sigmoidoscopy, and stool tests. The method of choice depends on accessibility due to cost and insurance coverage, medical condition, and patient preference. However, a colonoscopy is considered the gold standard when it comes to screening for colorectal cancer.3 The annual screening percentage increased nationwide to 67% of those eligible in 2016, from 66% in 2012.4
A colonoscopy is performed using a flexible, long tube that has a camera attached at one end. The procedure lasts between 30 to 60 minutes and is repeated every 10 years if patients are not at an increased risk for colorectal cancer. As with other tests, a colonoscopy comes with its own advantages and disadvantages. It is 1 of the most sensitive tests available. It allows for visualization of the entire colon and rectum. In addition, biopsies can be performed, and polyps can be removed during the procedure. However, polyps that are too small might not be detected. There are also bleeding risks that could result from tears in the organ wall and tissue removal. In addition, this procedure does require thorough cleansing of the colon beforehand to prevent visual obstruction that could interfere with or prolong the process.5
Preparation for a colonoscopy requires modification to the patient’s diet and medication regimen. Patients are limited to a clear liquid diet the day before the procedure. Specific medications such as blood thinners may need to be stopped, because of the risk of bleeding. Patients are usually required to take a laxative or use an enema kit to empty the colon. FDA-approved preparations include hyperosmotic agents (sodium phosphate and sodium sulfate), isosmotic agents (polyethylene glycol-electrolyte), and combination agents (sodium picosulfate/magnesium oxide/citric acid).6
A combination product containing magnesium sulfate, potassium chloride, and sodium sulfate7 (Sutab; Sebela Pharmaceuticals) received FDA approval on Nov 10, 2020. This osmotic laxative is indicated for cleansing the colon in preparation for a colonoscopy in adults. When taking this therapy, a low-residue breakfast may be consumed but only clear liquids can be consumed until after the colonoscopy. Each dose of Sebela's combination product is 12 tablets that must be taken while drinking 16 ounces of water and using the split-dose method. Two doses (24 tablets) are required for a complete colonoscopy preparation. Inactive ingredients in this therapy include ethylene glycol, polyethylene glycol 8000, sodium caprylate, and vinyl alcohol graft copolymer.8
The US Preventive Services Task Force recommends adults ages 50 to 75 years be screened for colorectal cancer. Not screening puts the person at higher risk of getting colorectal cancer. A colonoscopy can paint a thorough picture of the colon and screen patients for possible cancerous legions or polyps. Sutab cleanses the colon prior to a colonoscopy. Prevention is always better than facing cancer, so remind patients about the possibility of colorectal cancer, especially if there is a family history. Educate patients about the advantages and disadvantages of colorectal cancer screening and performing a colonoscopy at the recommended ages.
Saro Arakelians, PharmD, is vice president of pharmacy operations at Mini Pharmacy in Los Angeles, California. Ngoctran Tran is a PharmD candidate at the University of Southern California School of Pharmacy in Los Angeles.
- CDC. Colorectal (colon) cancer. Updated April 16, 2020. Accessed December 3, 2020. https://www.cdc.gov/cancer/colorectal/
- Colorectal cancer: screening. US Preventive Services Task Force. October 27, 2020. Accessed December 3, 2020. https://uspreventiveservicestaskforce.org/uspstf/draft-recommendation/colorectal-cancer-screening
- Colorectal cancer screening. American Society for Gastrointestinal Endoscopy. Updated July 2017. Accessed December 3, 2020. https://www.asge.org/home/about-asge/newsroom/media-backgrounders-detail/colorectal-cancer-screening#:~:text=Colonoscopy%20is%20considered%20the%20gold,as%20family%20history%20of%20CRC
- CDC. Use of colorectal screening tests by state. Updated July 15, 2020. Accessed December 3, 2020. https://www.cdc.gov/cancer/dcpc/research/articles/use-colorectal-screening-tests-state.htm
- Mayo Clinic. Colon cancer screening: weighing the options. November 28, 2018. Accessed December 3, 2020. https://www.mayoclinic.org/diseases-conditions/colon-cancer/in-depth/colon-cancer-screening/art-20046825
- A-Rahim YI, Falchuk M. Bowel preparation before colonoscopy in adults. UptoDate. June 23, 2020. Accessed December 3, 2020. https://www.uptodate.com/contents/bowel-preparation-before-colonoscopy-in-adults
- Sutab [prescribing information]. Holbrook, MA; Braintree Laboratories, Inc: 2020. Accessed December 3, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213135s000lbl.pdf
- Sutab. Drugs.com. Updated on November 22, 2020. Accessed December 4, 2020. https://www.drugs.com/sutab.html#:~:text=Each%20dose%20of%20Sutab%20is,prevent%20fluid%20loss%20(dehydration)