On July 9, the FDA announced that it was strengthening the warning on the class of medications known as “non-steroidal anti-inflammatory drugs” or NSAIDs. This includes the over-the-counter (OTC) drugs ibuprofen (also known as Motrin or Advil) and naproxen (also known as Aleve), and several different prescription drugs used to treat pain. It does not include acetaminophen (Tylenol), and the warning does not include aspirin. The concern is that research now indicates that even short-term use of NSAIDs can increase the risk of heart attack or stroke, also called “cardiovascular events.”
NSAIDs have been around for a long time. Ibuprofen was patented in 1961, approved by the FDA in 1974, and became OTC in 1984. It is on the WHO List of Essential Medicines, a list of minimum medicine needs for a basic health‐care system. Naproxen became available in the US in 1994. NSAIDs are used for a number of painful conditions, including arthritis, menstrual cramps, headaches, muscle aches, injuries, surgery, and aches and pains from colds and flu.
We have known about the possibility of increased risk of heart attack or stroke with NSAIDs since the uproar over Vioxx in 2004, when it was removed from the market due to increased risk of heart attack and stroke with long-term use. The FDA has required a “Boxed Warning” on NSAIDs since 2005, describing the risk of heart attack and stroke with long-term use.
The recent statement from the FDA says that the risk of heart attack and stroke is increased with long-term, higher dose use, but can be increased even with short term use. Not all NSAIDs appear to have the same degree of increased risk, but it’s not clear whether one NSAID is ‘safer’ than another. The risk is increased most in people with risk factors for cardiovascular disease, because their risk is higher at baseline.
Risk factors for cardiovascular events include high blood pressure, high cholesterol, smoking, obesity, sedentary lifestyle, diabetes, high use of alcohol, and family history. Symptoms of stroke include sudden onset of facial droop, arm or leg weakness, or speech difficulty. Symptoms of heart attack include chest pain or pressure, jaw pain, headache, shortness of breath, sweating, nausea/vomiting, stomach discomfort, heartburn/indigestion, and arm or upper back pain. About 1 in 4 heart attacks are “silent,” or produce no noticeable symptoms. If you experience symptoms, call 911 – don’t try to drive yourself to the hospital!
So…if you take an NSAID, should you stop? That depends. All medications have risks and benefits. Not taking medications has risks and benefits. For many people, NSAIDs improve their quality of life and ability to function. NSAIDs can help people be more active and sleep better, which reduces the risk of cardiovascular events. There is research evidence that indicates combining NSAIDs with other medications, such as opioids (narcotics) or muscle relaxers, can improve the effect of those medications. Taking the lowest effective dose for the shortest time is probably wise. If you take an NSAID, and are concerned, talk to your health care provider about whether you should continue.
At North Shore Pain Management we provide advanced, evidence based, multidisciplinary and cost effective pain management. Our goal is to improve your ability to return to the activities you have been missing as well as provide a meaningful reduction in pain.