Study shows 1 in 8 patients at risk of developing serious ADE take OTC NSAIDs

European League Against RheumatismJun 13 2013

Important to alert vulnerable patients to risks of OTC NSAIDs, particularly when their risk profile changes

A new study presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism, shows that one in eight patients at risk of developing a serious adverse drug event (ADE) is taking over-the-counter (OTC) non-steroidal anti-inflammatory drugs (NSAIDs), often to treat a musculoskeletal complaint.

Of these high risk OTC NSAID users, over one-third had taken the medication for more than 7 days, and 3% had exceeded the maximum recommended daily dosage.

Patients were considered at high risk of a serious ADE from OTC NSAIDs if they had a history of a peptic ulcer or ulcer complication, myocardial infarction, stroke or heart failure, were aged over 70 years, had a glomerular filtration rate < 30ml/L, or had a combination of two or more of the following: use of an anticoagulant, aspirin, corticosteroid or selective serotonin reuptake inhibitor; age 60-70 years; history of severe rheumatoid arthritis or diabetes mellitus.

Possible serious ADEs include gastrointestinal bleeding, peptic ulceration, high blood pressure and worsening heart failure.

"NSAIDs tend to be regarded by patients as harmless painkillers. However, in reality, even those available over the counter can cause a number of unpleasant side effects," said lead author of the study Aafke Koffeman of the Department Of General Practice, Erasmus Medical Center, Rotterdam, Netherlands.

"In most cases, it is likely to be ignorance of these potential ADEs rather than a deliberate disregard of the risks and contraindications", Ms Koffeman speculated. "These new data highlight the importance of healthcare professionals continuing to inform their patients of the risks of taking OTC NSAIDs, particularly where a new diagnosis or prescription increases their individual risk. High risk patients with painful musculoskeletal complaints should be advised to take safer alternative painkillers," she concluded.

Complications from the use of NSAIDs by high risk patients are a common cause of unplanned hospital admissions related to medications, which in turn constitute a significant public health problem. Two previous Dutch observational studies have shown that approximately 5% of all unplanned hospital admissions are associated with ADEs, of which 40-46% are potentially preventable.

This study was among adults registered with four Dutch general practitioners (GPs). Two samples of different patient populations were selected: (i) a random sample of adults (general population), and (ii) a sample of adult patients with a high risk of developing a serious ADE from NSAID use (high-risk population).

Patients' risk profiles were determined using their electronic medical records. All included patients were sent a questionnaire regarding their use of OTC NSAIDs in the four weeks prior to participation. In the high-risk population, of the 265 patients who agreed to participate, 33 (13%) had used an OTC NSAID. In the general population sample, of the 120 patients who agreed to participate, 35 (29%) had used an OTC NSAID.

Over 30% of OTC NSAID users had used the treatment for more than seven days in the high risk-population, and over 20% in the general population. OTC NSAIDs were used in a dosage exceeding the recommended daily maximum dose by 3% and 9% in the high-risk and the general populations respectively.

Musculoskeletal complaints formed the most commonly cited reason for OTC NSAID use in the high-risk group; 67% gave this as a reason for use.