Gastrointestinal Warnings on Nonprescription Products

Nonprescription products carry a host of warnings and precautions against use when a physician has not been involved in their selection (i.e., unsupervised self-care). Some of these warnings involve the gastrointestinal (GI) tract. The warnings are critical for the pharmacist to understand and communicate to the patient during self-care counseling sessions to help avoid patient harm from use of contraindicated nonprescription products and to ensure that patients obtain appropriate medical care when necessary.

Swallowing Disorders

Some nonprescription products carry labels warning against use if the patient has problems in swallowing food.¹ Dysphagia (trouble swallowing) can be due to Parkinson’s disease, stroke, head injury, or cancer of the head, neck, or esophagus.^2,3 Mineral oil and bulk laxatives (e.g., Citrucel, Metamucil) are contraindicated if the patient has dysphagia, but for different reasons. The patient with dysphagia may accidentally aspirate mineral oil, causing lipid pneumonia, pulmonary basilar infiltrates, and pulmonary fibrosis that may lead to lung cancer.¹ Bulk laxatives can swell and block the throat or esophagus and may cause choking if they are not swallowed correctly.¹

Naproxen products (e.g., Aleve) warn patients against use if the patient has difficulty swallowing, but they also caution patients to seek medical care if it feels as though a tablet is stuck in the throat.¹

Nonprescription proton pump inhibitors (PPIs; e.g., Prevacid 24HR, Prilosec OTC, Zegerid OTC) carry a warning against unsupervised self-use if the patient has trouble swallowing or pain when swallowing.¹ Both warnings are meant to alert patients not to self-treat such serious conditions as HIV, thrush, achalasia, and esophageal inflammation, spasm, or ulceration (especially when the latter is due to doxycycline).⁴

If patients cannot swallow without chewing, they should avoid enteric-coated products such as bisacodyl tablets (e.g., Dulcolax).¹ Chewing a Dulcolax tablet could cause uncomfortable gastric spasms.

Persistent Stomach Problems

Self-treatable gastric problems are limited to those that are short-term and do not recur.¹ For this reason, many OTC products carry warnings against use if the patient has stomach problems (e.g., heartburn, upset stomach, or stomach pain) that persist. This warning is found with variations on products containing nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, and naproxen.

Nausea and/or Vomiting

Nausea and/or vomiting are troubling symptoms. The only type of nausea or vomiting considered self-treatable is that associated with motion sickness. The pharmacist should ask the patient or the patient’s caregiver(s) about a past history of motion sickness and whether the patient has undergone a trip within the past few hours (e.g., subway, plane flight, car trip, carnival ride).

Parents may bring in a young child who has been vomiting in the absence of motion. A common cause of vomiting not associated with motion is viral gastroenteritis. This viral infection is contracted through contact with other children or adults, as in day care, or through ingesting infected foods or beverages.^5,6 It is seldom serious, but patients must drink adequate fluids to replace the losses from vomiting and/or diarrhea. Other causes of vomiting are far more serious, so vomiting requires a physician appointment to ensure that the patient is not in danger.

Vomiting blood is considered a medical emergency, and self-treatment is never appropriate.⁷ Vomited blood may be bright to dark red.⁷ Vomiting blood can be due to liver damage; a bleeding esophageal, gastric, or intestinal ulcer; defects in GI blood vessels; esophageal or gastric inflammation or irritation; swallowing blood during a nosebleed; and gastric or esophageal tumors.

PPIs are contraindicated with nausea or vomiting. Their labeled indication is sour stomach or heartburn, and nausea and vomiting are not common with those minor gastric conditions. Each product also carries a more specific warning against unsupervised use if the patient has vomiting with blood.

All products labeled for constipation carry a warning against use in patients who are vomiting. This warning is present because nausea, vomiting, and abdominal pain are all possible symptoms of appendicitis, which can be mistaken for the abdominal cramping associated with uncomplicated constipation. Use of laxatives in a patient with acute appendicitis could lead to a ruptured appendix, a life-threatening condition requiring immediate emergency room care.

Sore throat products also carry a warning against use in patients who are vomiting. This warning is found on topical sore throat lozenges and sprays, and on all internal analgesics when used for sore throat. Possible causes of vomiting and sore throat combined include strep throat or tonsillitis, neither of which is self-treatable; nor are any of the other possible etiologies.

All salicylate-containing products carry a specific warning against use if the patient has nausea or vomiting with changes in behavior. This includes aspirin, magnesium salicylate, and bismuth subsalicylate. One or more of these ingredients may be found in internal analgesics, migraine products, back pain relievers, products for stomach discomfort (e.g., aspirin in Alka-Seltzer), and upset stomach/diarrhea products such as Pepto-Bismol. This warning is included to prevent the occurrence of Reye syndrome.⁸ The etiology of Reye syndrome remains unknown, but it is associated with administration of aspirin or salicylates to children with chickenpox or flu. Symptoms usually begin with nausea and vomiting, followed by irritable, negative, and belligerent behavior. Other symptoms include confusion, lethargy, mental changes, seizures, decerebrate posturing, and coma. The warning alerts all patients that further administration of salicylates in an ongoing case of Reye syndrome is contraindi-cated and could be deadly.

Some ibuprofen products carry a slightly different warning related to vomiting. For instance, Concentrated Motrin Infants Drops and Motrin Children’s Suspension warn patients to ask a physician before use if the child has lost “a lot of fluid” from continued vomiting or diarrhea. This warning is to prevent renal damage from the ibuprofen in patients whose kidneys may already be stressed due to inadequate fluid status. As described by the National Kidney and Urologic Diseases Information Clearinghouse, ibuprofen is one of the commonly used analgesics that can cause sudden-onset acute kidney failure.⁹ The condition can occur with a single dose and also with short-term use of not more than 10 days. The condition may be reversible if administration is halted immediately and if emergency dialysis is initiated.

Abdominal (Stomach) Pain

Abdominal pain is a troubling symptom for which patients request pharmacist assistance. It is most often due to trivial problems such as constipation or lactose intolerance. However, the cause may be far more serious, such as viral gastroenteritis, irritable bowel syndrome (IBS), food poisoning, appendicitis, abdominal aortic aneurysm, bowel obstruction, cancer, ischemic bowel, diverticulitis, Crohn’s disease, renal stones, pancreatitis, or ulcers. Obviously, the patient requires a medical appointment in order to explore this complicated differential diagnosis and eliminate serious medical conditions. It is tempting to rely on the patient’s reports regarding the severity of pain in making a referral decision. For instance, a patient may state, “The pain is really not so bad, so please go ahead and give me something to help.” Such demurrals from patients are dangerous, as colon cancer and early appendicitis may cause only a mild pain.¹⁰ Thus, any complaint of abdominal pain should be regarded as just cause for referral.

The warning against use with abdominal pain is found on the labels of all laxatives and all PPIs. Virtually all NSAID-type internal analgesic labels (e.g., aspirin, ibuprofen, naproxen) warn against use if the patient has stomach pain that “does not get better,” a warning that specifically applies to patients who might have gastric erosion due to their use, but also serves to warn patients about any of the other serious conditions causing stomach or abdominal pain.

Vaginal antifungals also carry a warning against use in the presence of lower abdominal pain.¹ Some sexually transmitted diseases, such as chlamydia, can cause lower abdominal pain, and this warning will alert the user to make an appointment.¹¹ The patient with chlamydia may also complain of vaginal discharge, pain when urinating, low back pain, nausea, fever, dyspareunia, or bleeding between periods.

Stomach Ulcers

All NSAIDs (including bismuth subsalicylate, aspirin, ibuprofen, and naproxen) carry warnings against use if the patient has ulcers, in order to reduce the risk of stomach bleeding with their use. However, there is also a specific warning against use with stomach ulcers for nicotine cessation gum and lozenge products (e.g., Nicorette). Either can increase the risk of ulcers, but the pharmacist can recommend nicotine transdermal patches, which do not carry this warning (e.g., Nicoderm CQ).¹

Diarrhea

Diarrhea is a potentially deadly condition, especially if it persists sufficiently to cause fluid and electrolyte disturbances.¹² As mentioned above, pediatric ibuprofen products carry a warning against use if the child has “lost a lot of fluid” due to vomiting or diarrhea.¹ Polyethylene glycol 3350 products (e.g., Miralax) warn patients to stop use and consult a physician if they develop diarrhea.¹

Bloody or Black Stools

Bloody or tarry black stools are both immediate cause for referral. Black stools usually indicate bleeding from the upper GI tract, while bright red blood is associated with bleeding from the large intestine, bowel, or anus.¹³ All PPIs and antidiarrheals (e.g., bismuth subsalicylate, loperamide) carry a warning against use if the patient has bloody or black stools.

Irritable Bowel Syndrome

IBS (also known as spastic colon, irritable colon, or spastic colitis) causes abdominal pain, cramping, fullness, gas, and bloating.¹⁴ Polyethylene glycol 3350 (e.g., Miralax) carries a label warning against use in IBS. Patients with IBS may also experience mucus in their stools.¹⁵ Loperamide (e.g., Imodium A-D) and bismuth subsalicylate (e.g., Pepto-Bismol) labels warn against use if there is mucus in the stool.

PATIENT INFORMATION

Common Problems You Can Self-Treat

You can treat several common problems related to the stomach and intestines. Heartburn and sour stomach can be treated with antacids, products such as Zantac 150 or Prevacid 24HR. However, you must read each part of the label closely, as each product carries age limits, safe time limits for self-use, warnings, precautions, dosing information, and conditions under which you should see a physician. If you ignore any of these items, you risk serious harm in many ways, such as by failure to get diagnosis and treatment for cancer.

You can also treat constipation with several different types of laxatives. When choosing a laxative, choose safer products such as docusate (e.g., Colace, Surfak). Avoid mineral oil and castor oil, and be sure you do not overuse such stimulants as senna and bisacodyl, as they can lead to dependence. Check the age limits on each package and do not give a product to a patient under the ages stated on the label.

You can self-treat diarrhea in patients aged 6 years and above with loperamide (Imodium A-D) or in those aged 12 years and above with bismuth subsalicylate (Pepto-Bismol). In each case, as always, make sure to read and follow the entire label.

When self-treating constipation or diarrhea, you must make sure that the conditions do not persist beyond a certain time (see below), because they are no longer safe to treat without a physician’s care.

When to See a Physician

There are a far greater number of instances in which you should see a physician. For example, vomiting is a common but potentially dangerous problem. The only type of vomiting you can treat without seeing a physician is when it was caused by motion sickness, as from a carnival ride or a trip in a boat, plane, or car. If the patient did not undergo any strange or unusual type of motion in the past few hours, you should see a physician. The patient may have a stomach flu, food poisoning, or any of a number of other conditions. If the patient continues vomiting and cannot drink fluid, the physician may order supplemental IV fluids to prevent and/or treat dehydration.

Diarrhea that lasts more than 48 hours from the first loose stool can also lead to dehydration and electrolyte loss. You can help prevent this by purchasing and using an appropriate electrolyte solution, such as Pedialyte. However, using this does not mean that you will be safe in allowing the diarrhea to go beyond 48 hours without seeking a physician’s care. No antidiarrheal product is safe for a child under the age of 6 years.

Constipation can be self-treated for no more than 7 days. It should never be self-treated if the patient has nausea, vomiting, or abdominal pain, as these could be signs of appendicitis.

Remember, if you have questions, Consult Your Pharmacist.

REFERENCES

1. Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
2. Swallowing disorders. MedlinePlus. www.nlm.nih.gov/medlineplus/swallowingdisorders.html. Accessed October 30, 2012.
3. NINDS swallowing disorders information page. National Institute of Neurologic Disorders and Stroke. www.ninds.nih.gov/disorders/swallowing_disorders/swallowing_disorders.htm. Accessed October 30, 2012.
4. Painful swallowing. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003116.htm. Accessed October 30, 2012.
5. Viral gastroenteritis. CDC. www.cdc.gov/ncidod/dvrd/revb/gastro/faq.htm. Accessed October 30, 2012.
6. Viral gastroenteritis. National Digestive Diseases Information Clearinghouse (NDDIC). http://digestive.niddk.nih.gov/ddiseases/pubs/viralgastroenteritis/. Accessed October 30, 2012.
7. Vomiting blood. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003118.htm. Accessed October 30, 2012.
8. Reye syndrome. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/001565.htm. Accessed October 30, 2012.
9. Analgesic nephropathy (painkillers and the kidneys). National Kidney and Urologic Diseases Information Clearinghouse. http://kidney.niddk.nih.gov/kudiseases/pubs/analgesicnephropathy/. Accessed October 30, 2012.
10. Abdominal pain. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003120.htm. Accessed October 30, 2012.
11. Chlamydia. CDC. www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm. Accessed October 25, 2012.
12. Diarrhea. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003126.htm. Accessed October 30, 2012.
13. Bloody or tarry stools. MedlinePlus. www.nlm.nih.gov/medlineplus/ency/article/003130.htm. Accessed October 30, 2012.
14. Irritable bowel syndrome. PubMed Health. www.ncbi.nih.gov/pubmedhealth/PMH0001292/. Accessed October 30, 2012.
15. What I need to know about irritable bowel syndrome. NDDIC. http://digestive.niddk.nih.gov/ddiseases/pubs/ibs_ez. Accessed October 30, 2012.

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