Non-Prescription Analgesics

    When a physician prescribes an analgesic, he must take into account any underlying causes of the pain being treated, other medical conditions that might be affected by the treatment, other medications that might complicate the therapy, allergic tendencies, and potential side effects. These concerns are obviously no less important with over-the-counter analgesics; but all too often, the media is the sole source of information for the lay person making an analgesic choice.
    Every day, about two percent of the American population takes an OTC analgesic, and we can only hope that most of them are reading the labels and seeking professional advice when appropriate. Statistically, most OTC choices are made in response to advertising, those irrefutable claims that one product is far superior to all others for whatever reason seems to be popular at the moment. Claims of the strongest, most recommended by doctors, most taken by doctors, better because you have to take far fewer pills to achieve pain relief goals, etc. seem to differ only in the product they are trying to sell.    
    Though generally careful not to make claims that can’t be supported, advertisers count on the gullibility and ignorance of the American consumer who hears hype with claims that don’t really mean much on careful analysis. Why else would we have such an array of “No-Aspirin” and “Non-Aspirin” products – “No-Aspirin for Colds”, “No-Aspirin for Arthritis”, “No-Aspirin for Allergies” – and they all have 325mg of acetaminophen as the sole active ingredient. Why wouldn’t someone want to take something “strong” enough for his pain that only requires dosing with three or four tablets a day rather than six or eight? How many products claim the strongest pain relief available without a prescription? The media further complicates OTC choices by the selective reporting of news about OTC products. For example, reports of liver damage with acetaminophen use and alcohol intake prompted many patients to change their OTC analgesics and many professionals to change their recommendations; but the fact is that out of the millions of people who have taken it over the years of acetaminophen’s availability, only about 200 cases of liver damage have actually been documented. Further, the majority of this relatively insignificant percentage of problem cases involved excessive and chronic intake of alcohol coupled with overdosages of acetaminophen, facts of crucial importance but that were nonetheless glossed over in media reports and thus unrecognized by the public. Thus interpretation of news about analgesics should be carefully undertaken, preferably with the well-informed assistance of a professional.    
    We would like to think that even though largely misled by the media, patients carefully read the labels, but the number of people who read the labels and ignore what they say is staggering. The number who buy and take these products without even reading the labels may be even more staggering, all points that highlight the need for pharmacists to question their patients about use of OTC medications when counseling. Patients getting prescriptions for NSAID’s or anticoagulants definitely need to be warned of interactions with any OTC non-acetaminophen analgesic, and warnings against combining alcohol with OTC analgesics of all categories may be appropriate. In fact the FDA has considered mandating warnings on all OTC analgesics about the hazards of taking them with alcohol. Research has demonstrated the risk of upper gastrointestinal bleeding and even kidney failure with NSAID’s, particularly with aspirin.
    The FDA has proposed mandated warnings concerning alcohol consumption with all OTC analgesics, and though the mandate has yet to be approved, many manufacturers are already including such warnings. Here are the proposed warnings: For products containing acetaminophen: “Alcohol warning: If you drink three or more alcoholic beverages daily, you should ask your doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of liver damage.” For products containing aspirin, carbaspirin calcium, choline salicylate, ibuprofen, ketoprofen, magnesium salicylate, naproxen sodium, or sodium salicylate: “Alcohol warning: If you drink three or more alcoholic beverages daily ask you doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of stomach bleeding.” For products containing combinations of acetaminophen with other analgesic or antipyretic ingredients listed in the Code of Federal Regulation: “Alcohol warning: If you drink three or more alcoholic beverages daily ask you doctor whether you should take [product name] or other pain relievers. [Product name] may increase your risk of liver damage and stomach bleeding.”
    In spite of improvements over the past few years in the statistics involving OTC analgesics in poisonings and overdosings, largely due to child-resistant packaging, these agents remain a concern, especially for children. Poisonings tend to occur when a caregiver has failed to fully engage the childproof cap, typically on a bottle of acetaminophen liquid, leaving the bottle accessible to a child who is familiar with the product. Double-dosing is not uncommon when multiple caregivers fail to keep each other informed when doses are administered to a child, allowing both Mom and Dad to give a full dose to a child within minutes of each other. Parents should be periodically reminded to pay close attention to those particular problems.
    Appropriate Pediatric Doses of Acetaminophen While this protocol can be helpful in most cases of having to dose acetaminophen, it doesn’t account for impaired renal or hepatic dysfunction. A simple alternate means of arriving a proper dose is to apply the old rule that says: 15 mg of acetaminophen for every Kg of body weight.


  In spite of potential side effects, adverse reactions, drug interactions, interactions with alcohol, and liabilities of overdose, OTC analgesics stand as an invaluable alternative to prescription, not only reducing the cost of healthcare, but facilitating ready availability of essential medical therapy. Compared with the benefits (pain relief, fever reduction, and even reduction in inflammation in the case of all but acetaminophen) derived by the public from these medications on a daily basis, the problems encountered with their misuse are relatively insignificant. To the patients who suffer irreversible damage due to overdosage or misuse, though, this is hollow praise. It is our responsibility as pharmacists to make sure our patients are aware of the potential dangers with these medications, for only through education of patients and caregivers can the incidence of adverse effects from these products be further reduced.