A number of drugs have been branded with the infamous black-box warning -- the strongest possible -- due to increased health risks associated with taking them. However, the burning question is: Do these warnings really serve their intended purpose?

Among several high-profile drugs given new black-box warning labels are non-steroidal anti-inflammatory drugs, or NSAIDs (painkillers that include ibuprofen and naproxen as well as the blockbuster Celebrex), which caution against possible cardiovascular and gastrointestinal risks. Other drugs on the black-box hit list include:

• Antidepressants, which may induce suicidal behavior.

• Two eczema creams, Elidel and Protopic, which have been linked to cancer in animals.

Additionally, when pharmacists give out these drugs, they also hand over consumer-friendly MedGuides explaining the drugs' risks and benefits. This is to make sure the only patients who take potentially dangerous drugs are those for whom the benefits outweigh the risks.

A Struggle to Protect Patients from Drug Danger

Black-box warnings are a no-brainer, if for no other reason than to underscore just how toxic most prescription pharmaceuticals really are; however, some observers suggest the federal agency may be relying too much on the warnings and accompanying printed materials. In fact, even FDA officials admit they are unsure as to how effective black-box warnings and MedGuides are in maximizing safe prescribing.

And while some critics believe black-box warnings don't offer much help, physicians don't seem to be much better ...

Researchers tracked the effectiveness of four Dear Doctor letters after the FDA posted a warning involving Rezulin (once produced by a Warner-Lambert subsidiary) that concerned potential liver damage. Based on Medicaid claims tracked solely in Ohio, the number of patients who actually got their liver enzymes checked never rose beyond 26 percent.

According to the study, physicians are only part of the problem: Researchers argued both pharmacists and patients must step up to the plate and take their share of the responsibility for paying attention to the medications they sell and take.

Therefore, merely handing patients a MedGuide with their black-box-labeled drug is certainly not enough to protect them from the harmful effects of pill popping.

USA Today April 26, 2005

Pharmacoepidemiology and Drug Safety, January 2005, Vol. 14, Issue 1: 1-9

Dr. Mercola's Comments:

New information on the latest black-box warnings has been surfacing with greater regularity lately, especially in regard to NSAIDs. So you might wonder: Will the average consumer truly notice these warnings? Even if they do notice, do their physicians, the government and the media supply them with enough information to realize the full extent of the danger they are exposing themselves to if they take them? If these drugs relieve their symptoms, will they still want to avoid them, even with the knowledge that their contents could be harmful? The answer to all three questions is: It's not likely. That leaves only one logical option for the informed consumer: Find a safer, non-toxic alternative that addresses the cause of the problem. When Bextra and Vioxx were removed from the market many found natural therapies to be effective options. The point to all of this is simple. Make the black-box warnings irrelevant by changing your lifestyle so you won't ever have symptoms that drugs would be needed for. If you suffer from chronic inflammation, do what is necessary to change your health for the better and look for safe alternatives for symptom relief while your body goes through the healing process. Related Articles: Up to 20% Of Drugs May Cause Unexpected Problems Finally -- FDA Admits That ALL Anti-Inflammatories May Kill You Modern Health Care System is the Leading Cause of Death