Reflections of a pharmacist: The new FDA NSAID warning
Monday, July 13, 2015
On July 9, the FDA published a new drug safety warning indicating there is a greater risk of heart attack or stroke related to the use of nonaspirin NSAIDs than previously believed. This warning soon spread to all the national and local media, and the questions started pouring in.
Is ibuprofen safe any longer? Will naproxen cause a heart attack? Should I stop taking my diclofenac for pain? Will doctors stop prescribing these things?
As a pharmacist who dispenses and recommends these products every day, I took a significant personal interest in this matter. What provoked this recent announcement? What data was reviewed that gave rise to this concern? And maybe most importantly: Does the news mean that we should change the way we recommend this popular and useful class of drugs?
By way of review, we remember that all prescription NSAIDs (nonsteroidal anti-inflammatory drugs) have carried a black-box warning about the cardiovascular and gastrointestinal risks associated with the use of these agents for some time. A "black box" on the package labeling is the FDA's strongest mechanism to raise awareness to potential side effects and risks associated with an approved medication.
But the recent FDA announcement intends to strengthen and broaden the concern about these agents and their risks to cause cardiovascular events like heart attack or stroke.
Below are my own opinions and personal summary of the information and should not be taken as medical advice or policy.
The reason for the FDA raising the level of concern seems to primarily be related to two reviews:
1. The FDA reviewed a meta-analysis of clinical trials that took into consideration most of the available studies evaluating the risks of cardiovascular events associated with NSAIDs (especially celecoxib, diclofenac, ibuprofen and naproxen). This was done in 2013.
2. The FDA also took into consideration the findings of a 2014 joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The publicly available materials related to this meeting are extensive, including the written transcripts of each of the two-day meetings (Day 1 alone is more than 450 pages long).
Their conclusion after this extensive review is that the dangers associated with the use of NSAIDs may be more serious than currently expressed in the black box warnings.
So what additional changes is the FDA making to the currently published warnings? You can read them yourself here, but let me summarize the most significant points as follows:
1. NSAIDs may increase the risk of heart attack or stroke earlier in treatment than previously appreciated, and in patients with no previous history. Even the first weeks of treatment raise the patient risk. Nevertheless, risk still increases with longer treatments, higher dosages and patients with pre-existing risk factors.
2. Treatment with NSAIDs in the first year after a first heart attack increased the risk of death compared to those not taking NSAIDs.
3. It is no longer as clear that all NSAIDs carry the same risk, but evidence is still insufficient to declare one product safer than another.
So how should we respond to all of this? As a pharmacist working as a consultant for an outpatient hospital pharmacy, I take these sorts of things seriously. However, at the same time, we must realize these findings alone do not necessarily change our prescribing plans.
It is one thing to recognize risks associated with certain medications. It is another thing to prove that changing our prescribing patterns will produce less risk while providing the same benefits.
Pain is real. And pain relief is an essential part of patient recovery from illnesses and surgeries. Medication alternatives to NSAID therapy exist — such as acetaminophen, opioids and topical products — but these also carry certain risks depending on the patient history and dose needed to accomplish sufficient analgesia.
This leads me to three reasonable thoughts for healthcare providers:
1. It seems reasonable to remind our patients that all NSAIDs are powerful medications. The fact that some are available OTC (over the counter) may mislead some consumers to think they are harmless. No one should take an NSAID unless the pain justifies such treatment.
2. It seems reasonable to remind patients and prescribers that starting with a lower dose than usual may be more appropriate. Maybe ibuprofen 400mg TID (three times daily) is appropriate with the option of one extra dose per day prn (as needed). Just a thought.
3. It seems reasonable to remind patients there is limited evidence at this point that naproxen is safer than other NSAIDs. The joint committee meeting voted 16-9 in favor of no real evidence proving naproxen is safer with respect to cardiovascular event risk.
NSAIDs are an important pharmacological drug class. We should not eliminate them or minimize their effectiveness. My personal advice to my patients and our providers is the same thing: Use NSAIDs when appropriate, and stick with the lowest effective dose for the shortest length of time.
Avoid ibuprofen (except for a single dose two hours after aspirin if needed) in patients taking a daily aspirin for the cardio protective effects after a heart attack or stroke. Always take them with food, and seek medical attention immediately if you experience chest pain, shortness of breath, sudden weakness or slurred speech.
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