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FDA对抗炎药物问题发出新的警告  

2015-09-01 02:47:28|  分类: 医药与健康 |  标签: |举报 |字号 订阅

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Introduction:

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of having heart attack or stroke. This new warning is based on a comprehensive review of new safety information. Given the widespread use of these drugs, both via prescription and over-the-counter (OTC), it is important that all physicians and consumers take heed.

Background Data:

NSAIDs including aspirin, ibuprofen (Motrin and Advil), Aleve (naproxen sodium), Celebrex (celecoxib), Feldene (piroxicam), and Voltaren (diclofenac sodium) are used extensively in the United States in the treatment of arthritis, menstrual cramps, headaches, colds and the flu. Despite their widespread use, the emerging picture is that these drugs at best may produce short-term benefits, but also long-term problems. For example, over 7,500 deaths each year in the United States are directly attributable to NSAID use. Also, use of NSAIDs in osteoarthritis many of these drugs actually accelerate the progression of joint destruction.

In terms of side effects, NSAIDs can cause minor issues like gastrointestinal upset, headaches and dizziness, as well as more serious side effects such as peptic ulcers, strokes, and heart attacks. NSAIDs are therefore recommended for only short periods. Nonetheless, millions of Americans use NSAIDs on a daily basis. More than 70 million prescriptions for NSAIDs are written each year in the United States. With OTC use included, more than 30 billion doses of NSAIDs are consumed annually in the United States alone. Based upon a new review by the FDA the widespread use of these drugs is problematic.

New Data:

The FDA first addressed the risk of having a heart attack or stroke with NSAID use back in 2005 that resulted in a boxed warning on prescription drug labels. Since then, they have reviewed a variety of new safety information on both prescription and OTC forms of NSAIDs including a large meta-analysis of clinical trials looking at safety of these drugs. Based on the FDA’s comprehensive review and the recommendations from the advisory committees, they are requiring label changes to reflect the following conclusions:

  • A large number of studies support the finding that NSAIDs cause an increased risk of serious cardiovascular events. Estimates of increased risk ranged from 10 to 50 percent or more, depending on the drugs and the doses studied.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is also an increased risk of heart failure with NSAID use.

To reduce the risk with NSAIDs, the FDA recommends using the lowest effective amount for the shortest possible time, as well as to seek medical attention immediately if after taking a NSAID, a person develops symptoms such as chest pain, shortness of breath, sudden weakness or numbness in one part or side of the body, or sudden slurred speech.

Commentary:

If the FDA is issuing a bigger warning on a drug, you can be assured that it is a serious issue. Here is my take; the problem with NSAIDs is that they are not curative. They are simply biochemical band-aids that are certainly not suitable for long-term use. My recommendation is to avoid using them entirely. To put this situation in perspective, let me paraphrase the “Tack Rules” from noted physician Sidney Baker, MD:

  • Rule #1: If you are sitting on a tack, it takes a lot of aspirin to take the pain away.
  • Rule #2: If you are sitting on two tacks, removing just one does not result in a 50% improvement.
  • Rule #3: The appropriate treatment for “tack sitting” is removal of all tacks.

The bottom line is that conventional medicine focuses on the masking of symptoms with drugs, rather than identifying and eliminating the cause. In contrast, the beauty of naturopathic medicine, to use Dr. Baker’s analogy, is that it focuses on the removal of tacks. After all, there is no such thing as a NSAID deficiency.

Reference:

http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm

Dr. Michael Murray
8/11/15

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