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FDA Is Criticized for Painkillers Regulation

April 11, 2007

- Trials Journal –

The FDA has recently been criticized for its regulation of the popular painkillers. Dr. Curt D. Furberg from the Wake Forest University School of Medicine, USA, says the agency causes unnecessary scare about the use of common pain relieving medications, which were proven to be safe; on the other hand, the U.S. FDA is rebuked for not taking action on restricting the use of those painkillers, which can cause serious side effects. The article by Dr. Furberg was published in the Trials online journal on April 11, 2007.

The author of the article says there are certain doubts in the fact that the FDA regulatory decisions are evidence-based. Such a conclusion was made after comparing the regulations of the same pain-relieving medications, namely the non-steroidal anti-inflammatory drugs, issued in Europe and in the USA. The author says that the decisions of European Medicines Agency and the United States Food and Drug Administration are contradictory.

While all the non-selective NSAIDs (e.g. ibuprofen, naproxen, diclofenac) are recognized in Europe as completely safe medications, the FDA added a black-box warning to all these agents, drawing the patient’s attention to the potential cardiovascular adverse reactions, which may potentially be caused by popular prescription and over-the-counter painkillers. On the other hand, Dr. Furber notes that while there are clear contraindications and warnings in Europe for selective COX-2 inhibitors (e.g. celecoxib/Celebrex), there is only “a vaguely worded warning” in the United States.

In his article, Dr. Furber refers to clinical studies and says that both positions are only partially right, because among the non-steroidal anti-inflammatory drugs (NSAIDs) there are medications that are much safer in comparison to COX-2 inhibitors, but there are also drugs that can carry the same risks as celecoxib, for example.

In fact, nowadays most of the commonly used painkillers belong to the NSAIDs. Ibuprofen (Advil), naproxen (Aleve) and diclofenac (Voltaren) are the example of non-selective NSAIDS, and celecoxib (Celebrex) belongs to the sub-group of selective NSAIDs, also known as COX-2 inhibitors. Unlike non-selective painkillers, COX-2 inhibitors do not irritate stomach; however, they are associated with the increased risk of heart attacks. That was the reason for the market withdrawal of two COX-2 inhibitors (Vioxx and Bextra) in the USA.

Dr. Furber says that the FDA recommendation to add a Black Box warning to all the painkillers was not evidence-based and it only caused unnecessary scare among patients about the use of NSAIDs. The doctor says that the safety varies among different NSAIDs. Thus, he says that naproxen (Aleve) is the safest painkiller according to several studies, which showed that even high doses (500 mg twice daily) of Aleve were not associated with an increased risk of heart attacks compared to a placebo.

On the other hand, Dr. Furber says that clinical studies show that another NSAID Voltaren is associated with the same serious side effects as COX-2 inhibitors, which were removed from the market. However, in accordance with the FDA regulations, both Aleve and Voltaren contain the same safety warning.

"Naproxen does not increase the risk of heart attacks and ought to be a painkiller of choice," said Furberg. "The FDA has failed to recognize the evidence that the risk of heart attack varies substantially among this group of drugs (non-steroidal anti-inflammatory drugs) and that Voltaren has the highest risk of all. Since it is the most commonly used NSAID, the unrecognized harm it has caused worldwide could be enormous."

Nick

External resources
http://www.trialsjournal.com/content/8/1/13
http://www.sciencedaily.com/releases/2007/04/070424155532.htm
http://fmsglobalnews.wordpress.com/