Many People Overdose on Ibuprofen (ADVIL, IBU-TAB, MOTRIN) and Similar Drugs

Nonsteroidal anti-inflammatory drugs (NSAIDs) — including aspirin (DURLAZA), ibuprofen (ADVIL, IBU-TAB, MOTRIN) and naproxen (ALEVE, ANAPROX, NAPRELAN, NAPROSYN) — are widely used in the U.S. and internationally.

Patients often turn to these drugs to reduce fever caused by infections and to treat inflammation or pain associated with numerous conditions including arthritis, dental problems, headache, menstruation and minor injuries.

Although these medications are generally effective for these uses, they also carry the risk of serious adverse events, including gastrointestinal bleeding (bleeding in the stomach or elsewhere in the digestive tract)[1] and sudden or progressive kidney damage or failure.[2] All NSAIDs, except aspirin, increase the risk of serious, potentially fatal cardiovascular adverse events (heart attack or stroke) in patients with or without heart disease and in those with or without risk factors for heart disease.[3]

The risk of these adverse events increases with higher doses of NSAIDs. Therefore, it is important not to overdose on these medications.

The labels that accompany both prescription and over-the-counter (OTC) formulations of NSAIDs typically include dosing instructions for the number of pills or capsules to take at any given time, how often the dose can be repeated and the maximum recommended daily dose.[4]

But do users of these medications overdose on them despite the dose instructions? A recent study[5] published in the March 2018 issue of Pharmacoepidemiology and Drug Safety found that to be true for many adult users of ibuprofen and other NSAIDs.

The recent study[6]

The study targeted adults who reported using an ibuprofencontaining drug in the last 30 days. These subjects were recruited through email invitations by internet marketing companies that sought people whose demographic characteristics were representative of the U.S. adult population.

Approximately 1,300 subjects reported use of ibuprofen at least once during the week that followed their enrollment in the study. The median age of these subjects was 45 years, 36 percent were male and over 80 percent had more than a high school education.

These subjects recorded in an online one-week diary all NSAIDs that they used each hour of the day and the dose that they took.

The study found that 87 percent of the subjects took only OTC ibuprofen, 9.5 percent took only prescription ibuprofen and the remaining 4 percent used both OTC and prescription ibuprofen formulations during the one-week study period.

Overall, 11 percent of all ibuprofen users exceeded the maximum recommended daily doses — 1,200 milligrams (mg) for OTC formulations and 3,200 mg for prescription formulations — on at least one day of the week. Most of this overdosing occurred among users of OTC formulations.

More than one-third of the subjects also simultaneously took another NSAID in addition to ibuprofen: 24 percent took aspirin and 17 percent took naproxen. Although aspirin users rarely exceeded their maximum daily dose, 23 percent of naproxen users did. Similar to ibuprofen, most subjects who overdosed on naproxen did so with OTC formulations.

Taking more than the recommended one-time dose for an OTC NSAID was the most influential factor for exceeding the maximum recommended daily dose: It increased the odds of overdosing by nearly eightfold.

Moreover, exceeding the onetime OTC NSAID dose was more common in users who took formulations with label instructions that called for taking just one pill at a time; 64 percent of the users of these one-pill dose formulations were not aware that they were supposed to take only one pill at a time.

Subjects who consumed more than the maximum recommended daily NSAID dose were more likely to have ongoing pain and poor physical function, and they tended to start with a higher dose (rather than starting with a lower dose to see if it was sufficient, as is recommended on the labels of many OTC NSAIDs).[7] In addition, these users had poor knowledge of some of the label recommendations for OTC product dosing.

What You Can Do

You should know which of your medications contain an NSAID. Regardless of whether this medication is a prescription or an OTC drug, you should carefully read and follow the dose instructions on the label. Do not exceed the recommended dose each time that you take the drug, take the next dose too soon or go over the maximum recommended total daily dose, unless a health care professional tells you otherwise.

If more than one of your medications contains an NSAID, you should think of the maximum dose as something that includes all of these medications. Consult your doctor for further dosing advice in this case.

Consult your doctor if your symptoms do not improve after taking OTC NSAIDs for more than 10 days.[8] Use the lowest effective dose of these medications for the shortest time to minimize the risk of adverse events.[9] If you have cardiovascular or kidney disease, consult your doctor before taking any NSAIDs.

References

[1] Food and Drug Administration. The Benefits and risks of pain relievers: Q & A on NSAIDs with Sharon Hertz, M.D. September 24, 2015. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107856.htm. Accessed May 3, 2018.

[2] National Kidney Foundation. A to z health guide: Pain medicines (analgesics). https://www.kidney.org/atoz/content/painmeds_analgesics. Accessed May 3, 2018.

[3] Food and Drug Administration. FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drug (NSAIDs) can cause heart attacks or strokes. July 9, 2015. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM453941.pdf. Accessed May 3, 2018.

[4] Geri-Care Pharmaceutical Corp. Label: Ibuprofen tablet, film coated (OTC drug). December 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0744c3ca-4224-4f6a-a033-880949b544fd. Accessed May 3, 2018.

[5] Kaufman DW, Kelly JP, Battista DR, et al. Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users. Pharmacoepidemiol Drug Saf. 2018;27(3):322-331.

[6] Kaufman DW, Kelly JP, Battista DR, et al. Exceeding the daily dosing limit of nonsteroidal anti-inflammatory drugs among ibuprofen users. Pharmacoepidemiol Drug Saf.2018;27(3):322-331.

[7] Geri-Care Pharmaceutical Corp. Label: Ibuprofen tablet, film coated (OTC drug). December 2017. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0744c3ca-4224-4f6a-a033-880949b544fd. Accessed May 3, 2018.

[8] Food and Drug Administration. The Benefits and risks of pain relievers: Q & A on NSAIDs with Sharon Hertz, M.D. September 24, 2015. https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107856.htm. Accessed May 3, 2018.

[9] Food and Drug Administration. FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drug (NSAIDs) can cause heart attacks or strokes. July 9, 2015. https://www.fda.gov/downloads/Drugs/DrugSafety/UCM453941.pdf. Accessed May 3, 2018.