Digestive Health Research
While progress is being made in our understanding of the gastrointestinal disorders, important questions remain. For example:
- What causes the disorders?
- Why do certain people get them?
- How do we best treat the conditions?
- How do we prevent the disorders?
- How do we cure them?
Sound medical research is needed to explore these questions. Here we report a sampling of research studies and medical news that provide clues to better understanding GI disorders. Each new advance adds a small piece to the puzzle, making the big picture clearer.
To learn more about medical research, visit our web site at www.giResearch.org.
Topics - Newest Postings Listed First
- Guidance Issued in UK for Amitiza in Treating Chronic Idiopathic Constipation
- Prevalence of Fructose Malabsorption in Irritable Bowel Syndrome (IBS)
- Chronic constipation associated with increased risk for colorectal tumors
- Bowel Disease A-To-Z Guide Launched In UK
- Higher Prevalence of Celiac Disease among Children with IBS
- DDW-2014 News
- Less Aggressive Treatment May Be Warranted for Many Cases of Diverticulitis
- Survey – Many Want Medication to Treat Celiac Disease
- A New Way to Contact the FDA’s Food and Cosmetics Information Center
- MRI modeling revealed abnormal anatomical structure in those with GERD
- Salmonella Gastroenteritis During Childhood is a Risk Factor for Irritable Bowel Syndrome in Adulthood
- Researchers Find Genetic Clue in Irritable Bowel Syndrome
- Probiotics May Reduce Diarrhea Burden in Preschoolers
- Small Particle Size Diet Helps Those With Diabetic Gastroparesis
- The Role of the Gut Microbiota in IBS and Bloating
- Fifty Years Later: Post-infectious Irritable Bowel Syndrome
- New Drug Application Submitted in Japan for the Treatment of Acid-related Diseases
- Small Intestinal Bacterial Overgrowth in Gastroparesis
- Capsule Bowel Prep in Development
- Early Research Suggests that IBS may Sometimes be Associated with Maternal Inheritance
- Researchers Discover Mechanism of Movement in the Bowels
- IBS Patients’ Self-Health Ratings Look Beyond GI Symptom Severity
- Probiotic Treatment for IBS Available Over the Counter in Ireland
- Hospitalizations for Constipation Increasing in Cost and Frequency
- Positive Phase 3 Trial Results of Eluxadoline in Patients with IBS-D
- Study Reports on Metaclopramide Nasal Spray Treatment for Gastroparesis
- New Treatment for IBS with Diarrhea Available for Men in Japan
- New Type of Fiber to be Tested in Treating IBS Symptoms
- FDA Offers New Online Reporting Method for Dietary Supplements
- NPR: Doctors Say Request for IBS Research Money is No Joke
- Social Security Announces New Compassionate Allowances Conditions
- Ondansetron May Ease IBS-D Symptoms
- Comprehensive Nonsurgical Treatment Helps Women wtih Pelvic Floor Dysfunction
- New Use for Imaging Technique in the Treatment of IBS
- FDA Issues Warning to Consumers on Certain OTC Laxatives
July 23, 2014 – The National Institute for Health and Care Excellence (NICE) has issued guidance on the use of lubiprostone (Amitiza) for treating chronic idiopathic constipation in the United Kingdom. The guidelines stipulate that the drug should only be considered in adults who have tried at least 2 laxatives at the highest tolerated recommended doses for at least 6 months, but who have not seen an improvement in their symptoms.
NICE clinical guidelines are recommendations on the appropriate treatment and care of people with specific diseases and conditions within the National Health Service (NHS) in the UK.
May 28, 2014 – Fructose can trigger or worsen symptoms in irritable bowel syndrome (IBS). A new study investigated the prevalence of symptomatic fructose malabsorption in those with IBS and tested whether any patient characteristics can help to detect fructose malabsorption.
After ingesting 25g of fructose, fructose malabsorption was found in 22% of those studied. Symptoms indicating intolerance to fructose were found in 28% of sampled individuals, not all of whom demonstrated malabsorption. There were no differences in IBS subtype or clinical symptoms between those who did or did not have malabsorption. However, young males had a greater incidence of malabsorption.
The authors recommend further studies to determine whether a low-fructose diet would help IBS patients who are intolerant to fructose, with and without malabsorption.
May 20, 2014 – A retrospective database study of existing records has found that people with diagnoses of severe chronic constipation (CC) have a potentially higher risk of developing colorectal cancer and non-cancerous (benign) colorectal tumors over time, compared to people without CC.
The study, which looked at medical record databases, reviewed data from over 100,000 patients (28,854 patients with CC and 86,562 without) for 2–5 years. In those with CC, 2.7% developed colorectal cancer vs. 1.7% of those without. For non-cancerous colorectal tumors, the proportion was 24.8% for those with CC and 11.9% for those without. The risks increased with the severity of the chronic constipation.
These findings demonstrate an association only – not a causation – between chronic constipation and the development of colorectal cancer and/or benign tumor. While further studies are needed to determine whether there is an underlying causal link, the authors recommend that doctors be aware of this potential association in order to monitor and treat their patients appropriately.
May 09, 2014 – The Association of Coloproctology of Great Britain and Ireland has launched a guide on their website to help patients find expert surgeons. The guide classifies surgeons by location as well as by their interest a large variety of different bowel conditions.
UK residents who need surgery as part of their treatment can use the guide to find a surgeon who specializes in their condition.
The guide can be found here: http://www.acpgbi.org.uk/specialists/
April 21, 2014 – A study published in the journal JAMA Pediatrics found a 4-fold increased incidence of celiac disease among children with IBS, but not in children with other functional abdominal pain conditions. This is similar to a recent finding in adults.
Results showed that 4% of the children with IBS tested positive for celiac disease, compared with 1% or less of those with functional dyspepsia and with functional abdominal pain.
The authors state that the identification of IBS as a risk factor for celiac disease might be of help in pediatric primary care, because it has become routine to test for celiac disease in all children with recurrent abdominal pain. Limiting celiac screening only to those with IBS may be beneficial in two ways. First it may reduce unneeded testing and screening costs in children who are no more likely than the general population to have celiac disease. Secondly, it could reduce the risks and long-term health consequences for children with IBS who are also living with untreated celiac disease.
Source: Cristofori F, et al. Increased Prevalence of Celiac Disease Among Pediatric Patients With Irritable Bowel SyndromeA 6-Year Prospective Cohort Study. JAMA Pediatr. Published online April 21, 2014. doi:10.1001/jamapediatrics.2013.4984
April 10, 2014 – Diverticulitis is a common disease in which small pouches in the GI tract become infected. A recent review of medical studies about diverticulitis that have been published over the past decade suggests that changes be made in the way the disease is often treated.
The reviewers observed advances in the understanding of diverticulitis, which warrant less frequent use of antibiotics and surgery. Among the findings were that the risk of recurrence of diverticulitis is low, and the risk of abdominal infection decreases with each recurrence.
This review was recently published in the Journal of the American Medical Association (JAMA). The authors conclude that future studies are needed to investigate interventions to reduce recurrence, especially given the increasing incidence of diverticulitis.
April 9, 2014 – Many people suffering from celiac disease are interested in potential medications to treat the condition, according to a published survey that measured the impact of celiac disease on a person’s life. Currently, a gluten-free diet is the only treatment for celiac disease.
Survey responses were analyzed from 352 patients with biopsy-confirmed celiac disease. Patients were asked whether they would take a medication to treat the condition, if available. Interest was highest among men, older respondents, frequent restaurant customers, those dissatisfied with their weight or concerned with the cost of a gluten-free diet, and those with a worse quality of life. Length of time since diagnosis and response to a gluten-free diet did not appear to increase interest in using medication.
Source: Tennyson CA, et al. Interest in medical therapy for celiac disease. Therap Adv Gastroenterol. 2013 Sep;6(5):358-64. doi: 10.1177/1756283X13492580.
April 8, 2014 – The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Food and Cosmetics Information Center (FCIC) has a new online contact form, enabling industry representatives and consumers to submit their inquiries electronically through the FCIC website.
The new online form will collect information needed to appropriately and efficiently prioritize and respond to each inquiry, allowing the FCIC to improve overall customer service and increase accurate and timely responses. The form is available at this link.
The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers that carry out the mission of the Food and Drug Administration (FDA). CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.
The FCIC toll-free telephone, 1-888-SAFEFOOD (1-888-723-3366) will continue to operate from 10 AM to 4 PM EST.
April 3, 2014 – A small study has demonstrated that magnetic resonance imaging (MRI) technology can reveal anatomical and functional differences between people with GERD and those without. The differences affect the normal way in which the esophageal and gastric (stomach) anatomy acts to prevent reflux.
The findings demonstrate in a non-invasive testing situation that the “functional anatomy” which normally helps provide a barrier to reflux, is altered in people with mild to moderate GERD. This helps to better understand the mechanisms by which reflux is normally prevented, as well as the changes which allow it to occur.
Salmonella Gastroenteritis During Childhood is a Risk Factor for Irritable Bowel Syndrome in Adulthood
March 24, 2014 – Based on data collected from a single foodborne Salmonella outbreak in 1994, researchers have shown that Salmonella-induced gastroenteritis during childhood (but not adulthood) is a risk factor for IBS.
The researchers identified and monitored a foodborne Salmonella outbreak that involved 1,811 people (mostly children) in Bologna, Italy. Clinical data were collected and long-term effects were assessed by mailing a questionnaire to 757 subjects, 16 years after the outbreak (when all of children were adults).
The prevalence of IBS was higher in individuals exposed to Salmonella as children, but not as adults, compared with controls. The authors conclude that given the high prevalence of acute gastroenteritis and Salmonella infection early in life, preventive measures may help reduce the risk of IBS in adulthood.
March 20, 2014 – A group of researchers studying a specific genetic defect concluded that about 2% of people with IBS carry a mutation in the SCN5A gene.
This defect causes disruption in bowel function by affecting a mechanism (sodium channel) involved with maintaining normal gastrointestinal motility.
The research is in early stages, but the results of this study give researchers hope of finding new therapies for this subset of people with IBS.
This work was supported by grants from the NIH, Mayo Clinic, and the Swedish Research Council.
Source: Beyder A, et al. Loss-of-function of the voltage-gated sodium channel naV1.5 (channelopathies) in patients with irritable bowel syndrome, Gastroenterology (2014), doi: 10.1053/j.gastro.2014.02.054.
March 17, 2014 – A randomized, double-blind, placebo-controlled trial found that children who received a prescribed daily doses of a specific probiotic had less days with acute infectious diarrhea as well as fewer episodes of diarrhea. The study was performed at four day care centers in Mexico in children under three years old.
Daily use of the live probiotic Lactobacillus reuteri DSM 17938 was also associated with a reduction in the number of days the children were absent from school and the number of times they visited the doctor. Results from the study can be used to establish evidence-based recommendations for the use of this probiotic in the prevention of infectious diseases in day care centers.
Source: Gutierrez-Castrellon P, et al. Diarrhea in preschool children and Lactobacillus reuteri: A randomized controlled trial. Pediatrics. 2014 Apr;133(4):e904-9. doi: 10.1542/peds.2013-0652. Epub 2014 Mar 17.
March 14, 2014 – A randomized controlled trial examined the effect of an experimental diet in people with diabetic gastroparesis, and found that a small-particle size diet may relieve upper GI symptoms.
Dietary restriction is required to treat both gastroparesis and diabetes. This study tested a usual diet for diabetes versus a nutritionally identical experimental diet, which differed regarding the particle size of the food. This was described as food that was "easy to mash with a fork into small particle size, e.g. mealy potatoes". Foods with husks or peels; seeds and grains; or compact, poorly digestible particles such as meat, raw vegetables, and pasta; were excluded.
GI symptoms such as nausea/vomiting, fullness after meals, and bloating were all reduced in those who received the small-particle diet. Nutrient intake, glycemic control, and quality of life were the same in both diets, although longer studies may be needed to test these findings.
Although dietary changes are frequently recommended for controlling GI symptoms in people with diabetic gastroparesis, this is the first randomized controlled study of a diet for diabetic gastroparesis. The 20-week study included 56 adults with insulin treated diabetes and gastroparesis.
Source: Olausson EA, et al. A small particle size diet reduces upper gastrointestinal symptoms in patients with diabetic gastroparesis: a randomized controlled trial. Am J Gastroenterol. 2014 Mar;109(3):375-85. doi: 10.1038/ajg.2013.453. Epub 2014 Jan 14.
March 10, 2014 – "Recent findings suggest that IBS is linked to clearly detectable gut microbiota alterations. Additionally, bloating can be related to specific kinds of diet, thus opening up promising paths towards an efficient disease management," says Professor Giovanni Barbara (University of Bologna, Italy). This was one of the topics presented at the Gut Microbiota for Health World Summit in Miami, FL, USA on March 8 and 9, 2014.
"Probably the best example of this interaction is the discovery that IBS symptoms develop in up to 10 percent of previously healthy subjects after a single episode of gastroenteritis caused by an infection through bacterial pathogens like salmonella, shighella or campylobacter, which can severely disrupt the microbiota balance," says Prof. Barbara.
Another important factor is nutrition. Recent studies show that certain foods can induce profound changes in the microbiota of IBS patients, thus prolonging and increasing the symptoms. The gut microbiota of healthy subjects remained stable and unaffected by these foods.
Read the full article from the American Gastroenterological Association here.
February 28, 2014 – Post-infectious IBS (PI-IBS) is a type of IBS which occurs after what appears to be a bout of infection in the stomach and intestines (gastroenteritis). While most people recover completely after the initial illness, some people do not. The infectious agent in PI-IBS is usually bacterial.
It has been 50 years since researchers first published a paper associating acute infectious gastroenteritis with persistent GI symptoms. An article published in the journal Neurogastroenterology & Motility reviewed the literature to determine what we have learned about PI-IBS in the past 50 years.
Many risk factors and mechanisms for PI-IBS have been discovered, including what type of infections are most likely to be associated with later symptoms. This research is helping to guide new treatments and understanding of IBS.
Read more about PI-IBS on this IFFGD web page.
February 28, 2014 – Takeda Pharmaceuticals has announced that they have submitted a new drug application (NDA) in Japan for a new class of drug to treat acid-related disorders.
The compound has been assigned the generic name vonoprazan fumarate. It belongs to a new class of acid secretion inhibitors called potassium-competitive acid blockers. They work slightly differently from proton-pump inhibitors (PPIs), which are currently among the most common treatments for these disorders.
The NDA was submitted based on positive results from Phase III clinical trials in Japan, for indications including erosive esophagitis, gastric ulcer, duodenal ulcer, and H. pylori eradication.
February 28, 2014 – A study has shown that small intestinal bacterial overgrowth (SIBO) can be somewhat common in those with gastroparesis.
In a study of 740 patients who were tested for SIBO, 39% of those who had gastroparesis tested positive. Overall, no significant difference in gastroparesis symptom severity was seen between positive and negative results in those with gastroparesis, but there was increased severity of bloating and excessive fullness during and after meals. Read the article abstract.
February 27, 2014 – Salix Pharmaceuticals is partnering with another company to develop a bowel prep compound that is in the form of a tasteless capsule.
Currently, people preparing for abdominal procedures or diagnostic tests such as colonoscopy must drink a bowel prep solution to help cleanse the gastrointestinal tract. Most liquid preparations require drinking a large quantity of the prep which many people find unpleasant to the taste. The RHB-106 preparation is a solid capsule which eliminates any unpleasant taste and could potentially make it easier for people to use.
February 26, 2014 – A small pilot study may show that some IBS is hereditary, and linked to DNA in the cells of the mother.
By analyzing the mitochondrial DNA of patients with IBS, IBD, and healthy controls, scientists found probable maternal inheritance in 17.5% of the people with IBS, compared to only 2% of otherwise healthy people and 0% the people with IBD.
Mitochondria are important structures inside our cells, and in humans are inherited only from the mother. Mitochondrial dysfunction has been implicated in disorders that often co-occur with irritable bowel syndrome, such as migraine, depression, and chronic fatigue syndrome. These findings suggest that about 1 person in 6 with IBS could have an IBS subtype related to mitochondrial function, and that further research in this area is warranted. Read the article abstract.
February 26, 2014 – Researchers led by a group at McMaster University in Canada have discovered a mechanism that helps us better understand how the bowels function. The finding may lead to a better understanding of how to treat people with disorders of nutrient absorption, diarrhea, constipation, and bloating.
Food in the intestine must be propelled along the gut from the stomach down to the colon (a movement referred to as peristalsis), and it also must be mixed to maximize the absorption of nutrients.
The mechanism of peristalsis has previously been demonstrated to be the result of a slow-wave pacemaker generated by special cells in the intestinal walls, called interstitial cells of Cajal (ICCs).
The researchers discovered that the mixing movement is generated by a second pacemaker that interacts with the first. Together, they create back and forth movements that optimize nutrient absorption. Read the article abstract.
February 14, 2014 – People with IBS tend to base self-ratings of health by including other factors in addition to their IBS symptoms, a recent study suggests.
The study looked at a sample of people with moderate to severe IBS, in order to understand how they rate their own health. The resulting self-ratings were correlated more with physical, psychological, and social issues rather than just with their IBS symptom severity. Worse perceptions of health included more severe non-digestive symptoms (such as fatigue), greater psychological distress, and more stressful life circumstances.
This finding suggests that improving treatments for IBS requires addressing more than just IBS symptom severity in order to increase an individual’s overall perception of health. Read the article abstract.
February 14, 2014 – An over the counter probiotic treatment for IBS is now available in Ireland.
The active probiotic culture, bifidobacterium infantis 35624, was originally discovered at the University College Cork, Ireland in the late 1990s. Since then, it has undergone clinical trials which have validated its efficacy in treating IBS symptoms.
This probiotic has already been approved for over the counter use in the US and Canada under the brand name Align, and will be sold under the brand name Alflorex in Ireland.
February 11, 2014 – New data shows that hospitalizations for constipation are increasing in frequency, and the associated costs are rising.
Researchers analyzed the National Inpatient Sample Database for hospital discharge codes related to constipation, from 1997-2010. This database contains records for over 7 million hospital visits per year.
From 1997 to 2010, discharges with a principal diagnosis of constipation increased by 128.6%. The average hospital charges for these patients increased 239.3% ($8,869 in 1997, adjusted for inflation, to $17,518 in 2010), although the average length of hospital stay only increased from 3.0 to 3.1 days in the same time.
The researchers speculate that the increase in hospitalizations for constipation may be due to the increasing use of medications that cause constipation, and that the cost increase is likely due to the increased number of diagnostic tests performed to test colon function. They conclude that constipation is an escalating burden on the health care system and recommend studies on preventative measures that could reduce this. Read the article abstract.
February 4, 2014 – Two Phase III clinical trials evaluating eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) has shown that the medication helps improve both stool consistency and abdominal pain. A total of 2,428 subjects were enrolled across the two randomized, double-blind, placebo-controlled studies.
The manufacturer, Furiex Pharmaceuticals, is hoping to file a New Drug Application with the FDA sometime in mid 2014. Eluxadoline has been granted Fast Track status by the FDA, a process designed to facilitate development and expedite the review of drugs to treat diseases with significant unmet medical need.
January 22, 2014 – A Phase 2b study of a new method for treating nausea and vomiting in diabetic gastroparesis seems to show benefit over a traditional form of the treatment.
The study looked at the efficacy and safety of metoclopramide as taken by a new nasal-spray delivery method versus by the usual oral tablets.
Delayed gastric emptying symptoms, which are typical of gastroparesis, can interfere with the absorption and efficacy of oral medications. A nasal spray is absorbed through the nasal membrane bypassing the gastric emptying. A Phase 3 study to further investigate the potential of this form of treatment is upcoming.
January 17, 2014 – Ramosetron hydrochloride (HCl) tablets have been approved in Japan for treating IBS-D in males. The drug will be available under the brand name Irribow OD.
Ramosetron HCl is a serotonin 5-HT3 receptor antagonist. It acts on 5-HT3 receptors in the gut to slow intestinal transit and can also reduce transmission of intestinal pain. It is currently only approved for use in select countries including Japan and India, but is under investigation in several other countries.
January 16, 2014 – Scientists from two universities are collaborating to develop and test a new type of fiber which may be useful in treating IBS.
The fiber was designed to reduce bloating, a common side effect of current fiber therapies for IBS. It was also designed to break down into a product which helps promote healthy intestinal flora, and to deliver these nutrients farther into the large intestine. Most fibers are broken down in the stomach and small intestine.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has awarded these researchers a grant to conduct a two-year clinical trial which will test the new fiber. The trial will be starting in early 2014.
January 13, 2014 – The U.S. Food and Drug Administration (FDA) is now accepting online submission of adverse event reports related to the use of dietary supplements. Both mandatory and voluntary adverse event reports may be submitted online. Reporting of dietary supplement adverse events is important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in identifying harmful products.
To submit a dietary supplement adverse event report, visit http://www.safetyreporting.hhs.gov.
January 16, 2014 – Recently NPR and other news channels reported that in his new memoir, former Secretary of Defense Robert Gates ridiculed investments in IBS research.
Now NPR has heard from doctors who treat Gulf War veterans, and researchers with the National Academy of Sciences' Institute of Medicine, including IFFGD board member Dr. Douglas Drossman, who say this is not so. IBS is a serious concern for returning military women and men. Read the full article here.
January 15, 2014 – The Social Security Administration (SSA) announced that they have added 25 new Compassionate Allowances conditions, including chronic intestinal pseudo-obstruction (CIP).
CIP is a rare disorder of gastrointestinal motility where coordinated contractions (peristalsis) in the intestinal tract become altered and inefficient. When this happens, nutritional requirements cannot be adequately met. Pseudo-obstruction in children is usually congenital, or present at birth. It may also be acquired, such as after an illness. Read more about the symptoms and treatment of CIP here.
The Compassionate Allowances program expedites disability decisions for Americans with the most serious disabilities to ensure that they receive their benefit decisions within days instead of months or years. Read the full press release here.
January 10, 2014 – A new study from Garsed and colleagues in the UK suggests that the prescription drug ondansetron (Zofran, Zuplenz) may relieve some of the symptoms of diarrhea-predominant IBS (IBS-D). Ondansetron has been in use for many years to decrease nausea and vomiting related to chemotherapy.
In the study, ondansetron was most useful to improve frequent loose stools and urgency in people with mild to moderate symptoms. No significant improvement was seen in abdominal pain. Reportedly, any benefit is usually seen within a few days.
The study was published in the journal Gut in December.
January 9, 2014 – Many women suffer from pelvic floor dysfunction (PFD), which can cause a range of symptoms that include bladder and bowel problems, such as constipation or incontinence, as well as pelvic pain.
A retrospective study from the University of Missouri concluded comprehensive pelvic floor rehabilitation, which may include exercises to strengthen or relax the pelvic muscles, biofeedback therapy, constipation management, medications, incontinence devices, and behavioral modification, can help provide relief without surgery.
Existing records from nearly 800 women who had undergone therapy were examined. Those who completed at least 5 comprehensive rehabilitation sessions reported an average of 80% improvement in urinary incontinence, bowel dysfunction, and pelvic pain. Women who have symptoms of pelvic floor dysfunction are encouraged to discuss their concerns and treatment options with their health care providers.
January 8, 2014 – Researchers at the University of Nottingham, including IFFGD Advisory Board member Robin Spiller, MD, are researching how Magnetic Resonance Imaging (MRI) can be used to study IBS.
In three new studies, Dr. Spiller and colleagues have used MRIs to study the volume of the colon and how it expands to make space for a meal; the transit time of a meal through the bowel; and how certain food triggers such as fructans and glucose act differently in different parts of the colon.
Their findings will help show how the bowel functions differently between healthy individuals and those with IBS. "In future," says Dr. Spiller, "We will be able to use our MRI techniques to test specific foods to understand how they will affect IBS."
January 8, 2014 – The Food and Drug Administration (FDA) has issued a warning to consumers that some of the over-the-counter (OTC) laxatives – those called sodium phosphate laxatives – are potentially dangerous if dosing instructions or warnings on the Drug Facts label are not properly followed or when there are certain coexisting health conditions.
The label of sodium phosphate laxatives states that they should be used as one dose per day for no more than three days. If you do not have a bowel movement after taking a dose, you should not take another dose of the product.
FDA is now warning that adults older than 55, and adults and children with certain health conditions or who are using certain other medications – including ibuprofen – should ask their doctor before using these products because they may be at increased risk for harmful side effects. These new warnings are not currently in the Drug Facts label and apply to both adults and children. Read the full FDA update here.