A study just published in the journal Rheumatology concludes that popular pain relievers called NSAIDs can raise the risk of developing blood clots in veins (venous thromboembolism or VTE) by 80 percent. Such clots can lead to life-threatening pulmonary embolisms (PE) in lungs. If a blood clot lodges in the lungs the risk of death within 30 days is 8 to 10 percent.
NSAIDs have a previous history of causing life-threatening complications. Until ten years ago, when Vioxx (rofecoxib) was pulled off the market because it increased the likelihood of heart attacks or strokes, doctors had no idea that such pain relievers could trigger severe cardiovascular reactions. Since then, however, other studies have confirmed that NSAIDs increase the risk of blood clots (JAMA, Oct. 4, 2006).
When the makers of Advil and Motrin IB were given the green light by the FDA to sell ibuprofen over the counter 30 years ago, we weren’t sure it was a great idea. This was the first nonsteroidal anti-inflammatory drug (NSAID) available without a prescription. It was a controversial decision.
Although the FDA had decided that ibuprofen was so safe that it did not require medical supervision, many physicians and some pharmacists weren’t so sure. Gastroenterologists were especially concerned about stomach irritation, as well as bleeding and perforated ulcers. In 1984 a group of independent pharmacists in Illinois removed ibuprofen from drugstore shelves. The vice-president of the Illinois Association of Community Pharmacists stated that “Some drugs are a little too potent or hazardous to be sold safely over the counter. We’re not refusing to sell it. We just want it behind the counter so we can advise our customers about how to use it safely.”
At that time health professionals were aware that ibuprofen and other NSAIDs like naproxen and diclofenac could cause fluid retention, aggravate blood pressure and trigger serious stomach ulcers. There were also a number of worrisome interactions with prescription drugs. Despite these concerns, the FDA ignored the worriers and rejected the concept of behind-the-counter drugs. The agency opened the door to widespread self-medication for aches and pains.
The American public seemed delighted. According to one survey, 23 million Americans use a nonprescription NSAID like ibuprofen or naproxen (Aleve) every day (Journal of Rheumatology, Nov. 2005). Most don’t bother to read the directions on the label and roughly half appear unaware of potential toxicity. If someone dies of a heart attack or pulmonary embolism, friends and family grieve but rarely consider an over-the-counter pain reliever as a possible trigger for the tragedy.
Did the FDA make a serious blunder when it approved NSAIDs for nonprescription use? Now that these life-threatening adverse reactions have come to light, can the agency admit it goofed?
The law that governs the FDA’s decisions is quite clear. No drug can be sold without a prescription if it is toxic or has a potential for harmful effects. Can anyone at the FDA deny that NSAIDs have a potential for several very serious harmful effects?
We recognize that putting the genie back in the bottle is virtually impossible. The FDA has a hard time admitting errors in judgement. And there is a lot of money at stake. These drugs make hundreds of millions of dollars for their manufacturers. The public has become so accustomed to using NSAIDs that there would be an outcry if ibuprofen or naproxen were no longer available at pharmacies, supermarkets or convenience stores. If you are using any NSAID, you must be aware of the potential risks.
NSAID Side Effects:
- Heartburn, indigestion, abdominal pain, nausea, vomiting, constipation, diarrhea
- Headache, dizziness, drowsiness, disorientation
Skin rash, sensitivity to sunlight, itching (potentially serious, so notify the MD!)
- Fluid retention, edema, high blood pressure
- Heart failure, heart attack, stroke
Ringing in ears, hearing changes
- Visual disturbances
- Ulcers, bleeding ulcers, perforated ulcers
- Liver damage, kidney damage
- Blood disorders, anemia
- Worsening asthma symptoms
- NEW: Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
Diagnosing deep vein thrombosis (a blood clot in a vein) can be tricky. Unlike a heart attack, symptoms can be subtle and harder to assess. The CDC estimates that anywhere from 300,000 to 600,000 people develop DVTs each year. Other experts put the numbers higher, closer to one million cases annually. If the clot lodges in a leg, the person may sense tightness, tenderness, swelling, redness or a feeling of heat in one leg. It the clot breaks loose and lodges in the lungs, symptoms can include shortness of breath, cough or generalized chest pain. These are medical emergencies and require immediate treatment!
For those who would like to consider non-drug ways to relieve aches and pains, there are a number of alternatives to NSAIDs. They include the spice turmeric, the Indian herb boswellia, juices (tart cherry, pomegranate, or vinegar with apple and grape) as well as home remedies like Certo and grape juice or gin-soaked raisins. Learn more details in our Guide to Alternatives for Arthritis or our book, The People’s Pharmacy Quick & Handy HomeRemedies.
Share your own experience with NSAIDs (positive or negative) in the comment section below.