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FDA is confused in its role of safe guidelines for drug use in the US

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After about 40 years of recommending that people take an aspirin a day to ward off heart attacks, the FDA has changed its mind. On May 7, 2014, Medline Plus, a web publication by the FDA, announced that the FDA has turned down a labeling change requested by Bayer to say that daily aspirin usage prevents heart attacks.

The FDA mission is to provide rules and regulations to keep food and drugs safe for consumers. On the other hand, the FDA has allowed about any pharmaceutical drug to be sold as long as the patients are warned of potential side effects.

Trying to serve the citizens and the pharmaceutical companies has turned out to create a highly conflicted set of FDA regulations for prescription and over-the-counter drugs. If one listens closely to television advertisements for prescription drugs, there are several points to be considered.

  • The pharmaceutical companies are selling directly to consumers.
  • The pharmaceutical companies are encouraging potential consumers to ask their doctors to prescribe the medications.
  • The major side effects often involve serious consequences, including blindness, death, cancers, strokes and heart attacks.
  • The expected results focus on constipation, headaches and dizziness.

In the meantime, there is increased pressure on supplement manufacturers to prove that their products are safe and effective. The FDA has provided an out for these suppliers as well. The “stay out of jail pass" for supplement manufacturers should make consumers wonder why they would ever take a supplement.

A claim for a flush-free niacin product says that it is an important B vitamin that helps support general blood vessel and circulatory health.* The official FDA disclaimer is linked by the asterisk.

*“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

You can learn more about the old version FDA guidelines for aspirin use from their official website. The new guidelines state that daily aspirin use should only be used for people that have had heart attacks or strokes.

The other factor in drug usage and guidelines are the physicians that treat specific illnesses. Recent recommendation by the American Heart Association on the use of statins will result in a rise of statin users by about 50%. This is despite the proven link between statin use and diabetes. In exceptional cases, statins destroy the liver, but the recommendation for testing liver functions has now been rescinded.

As with all drugs, it is important to get the information necessary to make an informed decision about the risk-reward factors in using any drug. For a drug that has been used for generations, the reversal of the recommended guidelines for aspirin use is an indication of the confusion by the FDA on the recommended application of the drug.



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