The U.S. Food and Drug Administration (FDA) has issued stronger warnings about widely used pain pills – both prescription and over-the-counter versions – because of an increased risk of heart attack and stroke.
The heightened 2015 label warnings apply to so-called non-steroidal anti-inflammatories (NSAID), painkillers that do not contain steroid medications such as cortisone. Although the warnings are aimed primarily at individuals with existing cardiovascular disease, and particularly those who have recently had a heart attack or cardiac surgery, a risk still exists for those with high blood pressure, and even for those without any cardiovascular condition whatsoever.
The agency now says that there is no period of NSAID use without risk, meaning that the risk of heart attack and stroke “may occur early in treatment, even in the first weeks.”
Prescription NSAIDs are ordered by doctors for patients with arthritis and other painful, inflammatory conditions. Popular OTC store-bought NSAIDs are intended for temporary reduction of minor pains such as headaches, backaches, muscular aches, strains, sprains, and menstrual cramps. They include ibuprofen (Motrin, Advil) and naproxen (Aleve). The warning doesn’t apply to aspirin.
NSAIDs are among the most widely used drugs worldwide for management of pain and inflammatory conditions. Their use has been associated with an increased risk of death or heart attack by up to 5 times that of non-users. The FDA first ordered warning labels on NSAID products in 2005 following reports over increased heart problems associated with best-selling painkillers such as Vioxx and Bextra.
Beware the Side Effects of NSAIDs
I began warning my patients about these drugs in 2001 when I first became aware of problems. Research has shown that NSAIDs affect certain enzymes that constrict the arteries, potentially increasing high blood pressure. They also have a pro-thrombotic effect, that is, they may promote the formation of blood clots, and can cause fluid retention and a worsening of an existing heart failure condition. According to research published in 2015, people who have had a previous heart attack may have an increased risk of atrial fibrillation (a cardiac arrhythmia with the potential to lead to stroke) when taking NSAIDs.
Daily doses of non-aspirin painkillers, such as extra-strength acetaminophen (Tylenol) and ibuprofen (Advil and Motrin) are believed to increase the risk of high blood pressure among women. A 2005 Harvard study found that women taking more than 500 milligrams daily of acetaminophen (the amount in one extra-strength tablet) had a 93 to 99 percent increased risk within three years compared to women taking less. More than 400 mg a day of over-the-counter NSAIDS (the equivalent of two ibuprofen) had a 60 to 78 percent increased risk compared to women taking less than 400 milligrams.
I always warned my patients to avoid acetaminophen (Tylenol), especially the extra strength variety, because of the potential as well for liver problems. A number of times patients tested high for liver enzymes, an indication of liver toxicity, and I traced the problem to acetaminophen.
As far as common aspirin is concerned, don’t use it routinely to prevent a heart attack, even though it has a blood thinning effect. Research has clearly indicated that aspirin is not a safe or effective option to avoid a first heart attack. Whether full-strength or low-dose, you run the risk of gastrointestinal pain, heartburn, ulcers, and bleeding. However, after a heart attack or when there is documented arterial disease, low-dose aspirin may be advisable per American Heart Association recommendations. Always check with your doctor before using.
It’s a lesser known fact that many painkillers poison the mitochondria in all our cells that produce adenosine triphosphate (ATP), the body’s basic cellular fuel. You don’t mess with ATP if you want to stay healthy. When drugs curtail your energy production, something has to give.
The use of pharmaceutical painkillers is a tricky business. All of them can generate side effects. Patients MUST talk to their doctors about the risks in relation to their condition. These drugs need to be taken with caution.
I’m glad the FDA is doing its job to protect consumers.
There are many natural remedies that can be tried instead of NSAIDs. They include:
- The supplement MSM. It’s an active form of the mineral sulfur that reduces the pain of many muscle and joint problems. Start with 1 gram a day and increase slowly up to 4 or 5 grams in divided doses with meals.
- Traumeel, a homeopathic remedy available in health food stores. You can buy it as a topical cream or sublingual tablet. It works well for various muscle aches and pains.
- Earthing (also known as grounding) offers a surprising and simple form of pain relief. Earthing means connecting with the natural, subtle and nurturing energy on the surface of the planet by going barefoot outdoors or sleeping, relaxing, or working indoors while in contact with conductive sheets, mats, and bands that are connected by a wire to the Earth.
- U.S. Food and Drug Administration. FDA Strengthens Warning of Heart Attack and Stroke Risk for Non-Steroidal Anti-Inflammatory Drugs. 2015.
- Olsen AMS, et al. The impact of NSAID treatment on cardiovascular risk – Insight from Danish observational data. Basic Clin Pharmacol Toxicol. 2014;115(2):179-184.
- Olsen AMS, et al. NSAIDs are associated with increased risk of atrial fibrillation in patients with prior myocardial infarction – A nationwide study. European Heart Journal –Cardiovascular Pharmacotherapy. 2015;1:107–114.
- Forman JP, Stampfer MJ, Curhan GC. Non-narcotic analgesic dose and risk of incident hypertension in US women. Hypertension. 2005;46(3):500-7.
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