The Complexities of Real-World Treatment: A Spicy Example
This entry was written by our talented intern and strategy associate, Serena Sukhbaatar, who has been with Ratio for several months. In the course of doing some research on the gastroenterology space, she discovered that there were some interesting challenges for drugs that have interactions with some commonly taken supplements, particularly turmeric. It illustrates the challenges of ensuring that a drug brand is able to deliver its promised benefits to customers and ensure a positive real-world experience. Below you’ll find an overview of the issue, along with links to learn more if this might have an impact on your brand.
Turmeric is a popular spice and herbal supplement, which contains an active ingredient, curcumin, that has both antioxidant and anti-inflammatory properties. FDA labeled it as “generally recognized as safe” (GRAS) when taken at the recommended levels (up to 60 mg).[1] Research has shown turmeric can be beneficial for a wide range of health issues including inflammation, degenerative eye conditions, metabolic syndrome, arthritis, hyperlipidemia, anxiety, muscle soreness after exercise and kidney health.[2] However, turmeric supplements may cause more harm than good according to recent cases of liver injury due to turmeric supplement use.
The American Journal of Medicine reported there is an increase in liver injury due to turmeric in the United States, which could reflect usage patterns or increased combination with black pepper. “Turmeric causes potentially severe liver injury that is typically hepatocellular, with a latency of 1 to 4 months and strong linkage to HLA-B*35:01”. [3] The annual scientific meeting of the American College of Gastroenterology also reported similar findings where they outlined 15 different case studies of drug-induced liver injury, related to turmeric supplements.[4-9] Researchers found that middle-aged women who used the supplement for arthritis, pain relief, or general health were most frequently the ones who experienced liver damage caused by turmeric in studies. Symptoms including fatigue, nausea, and jaundice were typically experienced after 84 days after first use. Three of the seven turmeric products that were obtained from people who had liver damage in the clinical research study also included piperine, or black pepper. Black pepper can "significantly increase” turmeric's systemic bioavailability, or a substance's capacity to be absorbed and utilized by the body, which might also make liver injury more likely.
Before taking turmeric supplements, it is recommended that patients talk with their healthcare providers if they are getting chemotherapy or have a family history of kidney stones. A turmeric supplement should not be taken together with nonsteroidal anti-inflammatory drugs (NSAIDs), blood thinners, chemotherapy medications, indomethacin and tacrolimus as it may lessen the effect of the medication or increase side effects. Successful drug therapy depends on a lot of factors beyond the effectiveness of the drug itself. Taking a wider view can help pharma companies get better information to patients and physicians and increase the value their brands can offer.
References:
FDA. (n.d.). Curcumin from turmeric (Curcuma longa L.). U.S. Food and Drug Administration. Retrieved February 1, 2023, from https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices&id=686
Brown, M.-E. (n.d.). Turmeric Benefits. Turmeric Benefits. Retrieved February 1, 2023, from https://www.hopkinsmedicine.org/health/wellness-and-prevention/turmeric-benefits
Halegoua-DeMarzio D, Navarro V, Ahmad J, et al. Liver Injury Associated with Turmeric-A Growing Problem: Ten Cases from the Drug-Induced Liver Injury Network [DILIN]. Am J Med. 2023;136(2):200-206.
Ajayi T, Comer L, Kuntz L, et al. Turmeric-induced liver injury: a rare case of DILI. Poster presented at: American College of Gastroenterology 2022 Annual Scientific Meeting; October 21-26, 2022; Charlotte, North Carolina. Abstract available at: https://www.eventscribe.net/2022/ACG-Posters/fsPopup.asp?efp=VlZRRFFHSk4xNzEyNg&PosterID=513584&rnd=0
Afiniwala S, Khalid F, Mohan G, et al. Turmeric-associated liver injury: the yellow in your food causing the yellow in your skin. Poster presented at: American College of Gastroenterology 2022 Annual Scientific Meeting; October 21-26, 2022; Charlotte, North Carolina. Abstract available at: https://www.eventscribe.net/2022/ACG-Posters/fsPopup.asp?efp=VlZRRFFHSk4xNzEyNg&PosterID=514850&rnd=0
Chang P, Liu A. A superfood with a dark side: a case of severe liver injury due to turmeric. Poster presented at: American College of Gastroenterology 2022 Annual Scientific Meeting; October 21-26, 2022; Charlotte, North Carolina. Abstract available at: https://www.eventscribe.net/2022/ACG-Posters/fsPopup.asp?efp=VlZRRFFHSk4xNzEyNg&PosterID=513565&rnd=0
Ashraf B, Brown T, Saeed S, Saeed Z, Tambovtseva A. Skin as yellow as turmeric: a case report on turmeric-induced liver injury. Poster presented at: American College of Gastroenterology 2022 Annual Scientific Meeting; October 21-26, 2022; Charlotte, North Carolina. Abstract available at: https://www.eventscribe.net/2022/ACG-Posters/fsPopup.asp?efp=VlZRRFFHSk4xNzEyNg&PosterID=516330&rnd=0
Garcia Lopez J, Kee T, Marwil Z. Too much turmeric? A case of drug-induced liver injury. Poster presented at: American College of Gastroenterology 2022 Annual Scientific Meeting; October 21-26, 2022; Charlotte, North Carolina. Abstract available at: https://www.eventscribe.net/2022/ACG-Posters/fsPopup.asp?efp=VlZRRFFHSk4xNzEyNg&PosterID=513720&rnd=0
Halegoua-DeMarzio D, Navarro V, Ahmad J, et al. Liver injury associated with turmeric-a growing problem: ten cases from the Drug-Induced Liver Injury Network [DILIN]. Am J Med. 2022;S0002-9343(22)00740-9. doi:10.1016/j.amjmed.2022.09.026.