NSAIDs – The FDA Has Weighed In

Modern conventional medicine is a mixed bag. Pharmaceutical drugs certainly have their place, and for sure, some of them are quite literally lifesaving. However, all too often, prescription drugs, as well as those that are available over the counter, are merely band-aids; they are intended to help manage symptoms, but they typically do nothing to address the underlying causes of those symptoms. Moreover, many pharmaceutical medications come with multi-page inserts full of warnings about undesirable and unpleasant side-effects. Undesirable and unpleasant are bad enough, but some effects of very commonly used drugs can be downright deadly.

The U.S. Food and Drug Administration (FDA) recently updated its warning about non-steroidal anti-inflammatory drugs, or NSAIDs, which are used mainly as pain relievers. One of the long-recognized potential effects of NSAIDs is gastrointestinal bleeding—which may, in some cases, become life-threatening. The updated warning, however, focuses on separate, but possibly even more sinister potential outcomes from taking these products: heart attacks and strokes. According to the FDA, risk for heart attack or stroke can occur within weeks of using an NSAID, with the possibility for increased risk with longer use and higher doses. It is not yet known for certain whether different types of NSAIDs carry different levels of risk (for example, naproxen versus ibuprofen). As stated by the FDA, current scientific evidence “is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.” Patients with other risk factors for heart disease and stroke may be at greater risk for these complications from NSAIDs, but NSAID use elevates risk even in individuals with no predisposing issues.

Another somewhat alarming finding by the FDA is that “Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.” This is particularly disturbing because heart attack patients are often encouraged to take low-dose aspirin daily in an effort to prevent future coronary events. Additionally, the FDA notes an association between NSAID use and increased risk for heart failure. Clearly, this advice may be doing more harm than good. It is highly likely that, despite package inserts and warning labels, consumers are unaware that, as the Cleveland Clinic advises, NSAIDs should not be taken for more than three days in a row for fever, or ten days for pain without being monitored by a physician.

This presents a dilemma for doctors and patients: how to manage the sometimes debilitating and disabling pain of conditions such as osteoarthritis, tendonitis, or severe premenstrual cramps, while minimizing the potentially fatal side-effects of NSAIDs. The method embraced by the functional medicine community would be—if possible—to ascertain the underlying cause(s) of the pain and inflammation, and take precise steps targeted toward addressing the problem at its roots. To that effect, any number of strategies may prove effective, either on their own, or in conjunction with NSAID use, until the condition improves to the point where NSAID dose can be titrated down and, potentially, in time, be discontinued altogether.

Pain and inflammation can be induced by any number of factors. Ultimately, the mechanism by which these sensations arise in the body is upregulation or inducement of enzymes involved in the synthesis of pro-inflammatory prostaglandins, such as COX-1 and COX-2. (Many NSAIDs are non-selective, meaning, they inhibit both COX-1 and COX-2, while a selective NSAID, celecoxib, inhibits only COX-2. At the time of this writing, the only selective NSAID on the market is prescription-only Celebrex®, manufactured by Pfizer. Other selective NSAIDs were withdrawn from the market due to higher than expected reports of unfavorable side-effects, including death.)

Natural substances may help to alleviate inflammation, as might an overall anti-inflammatory diet. Anti-inflammatory herbs and spices include ginger, turmeric and rosemary, and a diet low in omega-6-rich vegetable and seed oils, and higher in plant and animal sourced omega-3s may also help correct the imbalance of pro- and anti-inflammatory prostaglandins. Helping patients identify undiagnosed food sensitivities could also prove to be an important strategy for reducing the need for high doses of pain relievers. For example, the Cleveland Clinic recommends avoiding nightshade vegetables and gluten, as these frequently exacerbate the pain associated with arthritis.

Like any pharmaceutical medication, NSAIDs may be of great help to some patients. However, the benefits should always be weighed against the risks, and steps should be taken to identify and correct the underlying imbalances that may be leading to inflammation in the first place.

Note: Temporary or once in awhile NSAID use is one thing.. Everyday use as we see on TV commercials (Alleve) is what will cause the long term problems.