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With Some Drugs, Crushing Tablets Or Opening Capsules Could Have Fatal Consequences

Worst Pills, Best Pills Newsletter article February, 2015

Some patients find it difficult or impossible to swallow large tablets or capsules. The problem is common in older patients with neurological disorders that impair swallowing, such as dementia and Parkinson’s disease; xerostomia (decreased saliva production causing dry mouth); and diseases of the throat and esophagus.[1] Young children also often cannot swallow pills or capsules.

To cope with this problem, patients, caregivers and health care providers frequently crush tablets or open...

Some patients find it difficult or impossible to swallow large tablets or capsules. The problem is common in older patients with neurological disorders that impair swallowing, such as dementia and Parkinson’s disease; xerostomia (decreased saliva production causing dry mouth); and diseases of the throat and esophagus.[1] Young children also often cannot swallow pills or capsules.

To cope with this problem, patients, caregivers and health care providers frequently crush tablets or open capsules and sprinkle the resulting powder, fragments or granules into food or liquids. Some patients also may resort to chewing on the pills or capsules before swallowing. However, a September 2014 review published in the highly regarded French drug safety bulletin Prescrire International warns that many medicines available in tablet or capsule form are not supposed to be crushed, opened or chewed before swallowing — and that doing so may have serious, sometimes deadly, consequences.

Different drug designs

Oral medications available in tablet or capsule form contain one or more active ingredients — the actual drugs intended to treat a particular disease or condition — and several inactive ingredients. Inactive ingredients include coating materials, flavorings,dyes and binders that hold together tablets or granules from capsules. Drug companies use complex manufacturing techniques to combine these ingredients into final products that are designed to release their active ingredients at a specific rate and in a specific location within the digestive tract, such as the stomach or the small intestine.

For example, some uncoated, immediate-release tablets are designed to disintegrate quickly in the stomach, where the active ingredients are then rapidly absorbed into the bloodstream. For these drugs to work, the active ingredients must be able to withstand exposure to the strong acid found in the stomach.

For other drugs containing active ingredients that would be broken down by stomach acid, manufacturers have designed tablets and capsules with acid-resistant coatings (often called enteric coatings). Only when these tablets or capsules move from the stomach to the small intestine does the coating dissolve, allowing release of the active ingredients.

In addition, many drugs in tablet or capsule form are designed to release their active ingredients even more slowly, over a period of 12 to 24 hours, as the tablets or granules from the capsule pass through the small intestine. This sustained-release (also called controlled-release, long-acting and extended-release) design provides the convenience of once- or twice-daily dosing while minimizing the variation in the amount of drug in the blood over the course of a day. This design can improve patient compliance and drug effectiveness while decreasing the risk of side effects.

Crushing a tablet, opening a capsule or chewing either of these can circumvent many of the design features intended to control when and where a drug is released in the digestive tract. Depending on the drug, this can result in overdosing, underdosing or direct toxic injury to the lining of the mouth, stomach or intestines. The recent Prescrire International review highlights examples of each of these potentially dangerous circumstances for several commonly used drugs.[2]

Drug overdosing

With some drugs, crushing a tablet, opening a capsule or chewing either before swallowing can cause the rapid absorption of a large amount of the drug, potentially resulting in an overdose. This can be particularly dangerous with drugs for which there is only a small difference between a drug level that is effective and one that is toxic. Such drugs include digoxin (LANOXIN) and anticoagulants (blood thinners).[3]

Digoxin is approved to treat heart failure and to slow the heart rate in patients who develop atrial fibrillation, an abnormal heart rhythm that causes a rapid, irregular heart rate. According to the authors of the Prescrire International review, crushing digoxin tablets before swallowing may increase the risk of dangerous abnormal heart rhythms.[4] These include heart rates that are too slow or too fast, or irregular rhythms, possibly causing death.

Likewise, the authors noted that opening capsules containing the oral anticoagulant dabigatran (PRADAXA) increases the amount of drug that is absorbed, exposing the patient to a greater risk of serious bleeding.[5] Both the Food and Drug Administration-approved drug label and the accompanying medication guide advise health care providers and patients that dabigatran capsules must be swallowed whole and warn against breaking, chewing or emptying the capsules before taking the drug.[6]

Sustained-release drugs also should not be crushed or chewed before swallowing because doing so will cause the rapid absorption of a large dose that was intended to be released slowly over many hours. (See box below for stories of patients who have been seriously harmed or killed after ingesting tablets that were chewed or crushed.)

Serious Adverse Events Following Chewing Or Crushing Sustained-Release Medications

Here are just a few stories published in the medical literature of patients who have been injured or have died after ingesting a sustained-release drug that was chewed or crushed:

  • A 70-year-old woman was hospitalized for a stroke. During her hospital stay, she experienced severe knee pain, which was treated — inappropriately — with long-acting tablets of oxycodone (OXYCONTIN, XARTEMIS XR), a potent opioid pain reliever. Because the patient had difficulty swallowing the tablets, they were crushed prior to administration. The next day, she developed respiratory depression (decreased breathing) and fell into a coma.[7],[8] Of note, the drug labels for sustained-release oxycodone products carry a black-box warning about the risk of serious, life-threatening respiratory depression. These warnings further advise that “crushing, chewing, or dissolving [the oxycodone] tablets can cause rapid release and absorption of a potentially fatal dose of oxycodone.”[9]

  • An elderly woman was prescribed a sustained-release version of diltiazem (CARDIZEM CD, CARDIZEM LA, CARTIA XT, DILACOR XR, DILT-CD, DILTZAC, TAZTIA XT, TIAZAC), a calcium channel blocker used to treat high blood pressure. Because she could not swallow the large diltiazem tablets whole, she chewed them before swallowing. Shortly thereafter, she felt faint, weak and sleepy. Her doctor diagnosed bradycardia (a very slow heart rate), a known side effect of excessive levels of diltiazem. The patient was subsequently prescribed an immediate-release form of diltiazem, which was easier for her to swallow. She did well until her physician again prescribed the sustained-release version of the drug months later. The patient resumed chewing the large diltiazem tablets and died three weeks later.[10]

  • A 38-year-old woman was hospitalized with poorly controlled hypertension, heart failure and pneumonia. After being stabilized with intravenous medications, she was given oral hypertension drugs, including labetalol (TRANDATE), a drug that reduces both blood pressure and pulse, and sustained-release nifedipine (ADALAT CC, AFEDITAB CR, PROCARDIA XL), a calcium channel blocker. These medicines were crushed and administered via a tube that had been placed through the nose and into the stomach. The patient then developed a very slow heart rate and hypotension (low blood pressure) and suffered cardiac arrest. She was successfully resuscitated but the following day was again given crushed labetalol (at a lower dose) and sustained-release nifedipine. She again experienced a severe drop in her heart rate and blood pressure, suffered cardiac arrest and died. Her drop in blood pressure was attributed to treatment with the crushed sustained-release nifedipine tablets.[11],[12]

Damaging the protective coating

In contrast to the prior examples, with other drugs, crushing tablets, opening capsules or chewing either of these before ingestion can result in patients receiving an insufficient dose of the active ingredient. This occurs commonly with medications that have an enteric coating, designed to protect the active ingredient from being destroyed as the tablet or capsule passes through the stomach.[13] Such drugs include proton pump inhibitors (drugs that suppress stomach acid production) and sulfasalazine (AZULFIDINE EN-TABS), which is used to treat rheumatoid arthritis and certain inflammatory diseases affecting the colon.

The authors of the Prescrire International review referenced a case of a 75-year-old man who had severe heartburn. He was diagnosed with severe gastroesophageal reflux disease. His doctor prescribed the proton pump inhibitor omeprazole (PRILOSEC, ZEGERID) twice daily. The omeprazole tablets were crushed before being administered via a tube placed in his stomach. After one month of treatment, the man’s heartburn symptoms persisted. Crushing the tablets likely compromised the integrity of their coating, allowing the stomach acid to inactivate the omeprazole and rendering the drug ineffective.[14]

Omeprazole is also available over the counter (OTC). The directions in the “Drug Facts” label on the OTC version instruct consumers to swallow the medicine whole and not to chew or crush the tablets.[15]

Finally, the authors of the Prescrire International review reported that some medications have a coating that is intended to prevent the active ingredients from causing ulcers and tissue injury to the mouth, stomach or intestines. For example, crushing certain iron supplements available in tablet form can cause ulcers in the mouth due to exposure to the iron.[16] Likewise, crushing certain potassium supplements can cause ulcers in the intestines.[17]

What You Can Do

When taking a prescription drug, you should never crush a tablet, open a capsule or chew either without first asking the prescribing health care provider or dispensing pharmacist whether doing so is safe.

For an OTC medication, carefully read the “Drug Facts” section on the label for any instructions advising whether the tablet or capsule should be swallowed whole without crushing, chewing or opening. Carefully adhere to such instructions.

If you are experiencing difficulty swallowing tablets or capsules and are taking a prescription drug that is unsafe to crush, chew or open, consult with the prescribing health care provider about other treatment options. There may be a liquid formulation of the same drug. There also may be another drug in a smaller tablet or capsule that you can swallow or that can be safely crushed or opened before ingesting.

References

[1] Crushing tablets or opening capsules: Many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.

[2] Ibid.

[3] Ibid.

[4] Ibid.

[5] Ibid.

[6] Boehringer Ingelheim Pharmaceuticals Inc. Drug label for PRADAXA. September 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ba74e3cd-b06f-4145-b284-5fd6b84ff3c9. Accessed November 25, 2014.

[7] Crushing tablets or opening capsules: Many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.

[8] Cornish P. “Avoid the crush”: Hazards of medication administration in patients with dysphagia or a feeding tube. CMAJ. 2005;172(7):871-872.

[9] Purdue Pharma LP. Drug label for OXYCONTIN. April 2014. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=bfdfe235-d717-4855-a3c8-a13d26dadede. Accessed November 25, 2014.

[10] Crushing tablets or opening capsules: Many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.

[11] Ibid.

[12] Schier JG, Howland MA, Hoffman RS, Nelson LS. Fatality from administration of labetalol and crushed extended-release nifedipine. 2003;37(10):1420-1423.

[13] Crushing tablets or opening capsules: Many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.

[14] Cornish P. “Avoid the crush”: Hazards of medication administration in patients with dysphagia or a feeding tube. CMAJ. 2005;172(7):871-872.

[15] ConsumerMedSafety.org. Cutting, crushing, chewing, opening, or dissolving medicines. March 7, 2014. http://www.consumermedsafety.org/the-basics/when-it-s-not-safe-to-cut-crush-or-chew-otc-medicines. Accessed November 25, 2014.

[16] Crushing tablets or opening capsules: many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.

[17] Crushing tablets or opening capsules: many uncertainties, some established dangers. Prescrire Intl. September 2014;23(152):209-214.