Over the course of the last year, we’ve heard reports of the potential dangers associated with several popular pain relievers, including some over-the-counter drugs. Below is a brief history of these medications and an explanation of the reasons for the FDA’s actions.
NSAIDs
Non-steroidal anti-inflammatory drugs (NSAIDs) are often the first line of defense in treating inflammation or minor pain. These drugs—including ibuprofen (Motrin or Advil), naproxen (Aleve or Naprosyn), or aspirin—work by inhibiting the Cox enzyme.
Although NSAIDs usually are well tolerated and effective, they can lead to stomach ulcers and gastrointestinal (GI) bleeding. NSAIDs also cause blood thinning due to the effect on platelets. While blood thinning can have some beneficial cardiac effects, it can have negative effects for patients taking medications such as coumadin or undergoing surgery. In some cases, these GI bleeds can cause people to become hospitalized; need transfusions; and, in rare situations, even result in death.
The Next Generation
As research continued, it was discovered that the Cox enzyme was actually two different enzymes: Cox-1 and Cox-2. The Cox-1 enzyme protects the stomach lining, so the next generation of anti-inflammatories was developed to work by inhibiting only the Cox-2 enzyme. The theory was that these medications would help prevent GI bleeds and become a safer alternative for patients with chronic pain (for example, arthritis sufferers).
These new drugs included Vioxx, Bextra, and Celebrex and seem to do a better job of preventing ulcers and GI bleeds. However, the benefits of the blood thinning—similar to the effects of taking baby aspirin—may be lost.
Because of the loss of the potential cardiac benefit, physicians became concerned about the possibility that more people would develop heart attacks and strokes. Initial studies suggested it did. However, the question was whether this was due to the fact that people stopped taking baby aspirin when taking Cox-2 inhibitors.
It eventually was determined that it’s not only the elimination of the baby aspirin, but may be the direct result of taking Vioxx that can cause an increase in the clotting effects that can lead to heart attacks and strokes. Because of this, Vioxx was taken off the market in fall 2004.
In April 2005, the FDA announced that Bextra would be pulled from the market due to these cardiac risks, as well as its link to the rare, but serious, skin disease Stevens-Johnson Syndrome. The FDA also determined the benefits of Celebrex outweigh the risks and allowed it to remain available to patients; however, it would now be required to carry a “black box warning”—the strongest possible warning detailing the risk of heart attack and stroke. Ibuprofen and naproxen also will be required to include stronger warnings on their packaging because they, too, may have the potential to increase the risk of heart attack and stroke. Aspirin doesn’t appear to increase this risk.
A Balancing Act
This news seems quite dire. People may wonder how these medications make it to the marketplace if they’re so “bad.” On the other hand, if you’re one of the patients who experienced relief from aching joints or other chronic pain, you may be frustrated by the FDA’s decision to remove your “wonder drug” from the market. In medicine, it’s all about balance—trying to find the most effective way to treat patients’ ailments while minimizing the risks.
In most cases, Celebrex and NSAIDs are safe to take in appropriate doses for short periods of time. But, as with any other medical decision, it’s important to talk to your doctor about your individual situation. He or she can advise you on the best way to deal with your chronic pain. TPW