July 10

Is A Drug You Take The 1 In 3 That Has Safety Issues?

If you don’t take the steps throughout your life to make good health decisions, you just may end up having to take medications to deal with health problems. And according to recent research published in the Journal of the American Medical Association, that may be risky in and of itself due to the number of medications that eventually have safety issues after they have already been approved!

In looking at drugs that were approved over a 10-year period from 2001 to 2010, researchers found that 32 percent of the drugs eventually had safety issues after approval! While the majority of the issues did not require actual withdrawal of the medications except in a few cases, it still makes one question whether the supposed benefits of the drugs outweigh the possible risks or complications, especially if there may be other means to get the body “right” without them.

Issues also come into play in regard to the approval process for new drugs. While one side of the coin is always that drugs are supposed to offer a health benefit or preserve life, don’t forget that the drug industry is big business and a lot of money for corporations is riding on them getting approved or not.

Many times, the pre-market drug testing and clinical trials for these medications involve fewer than 1,000 patients studied over a period of six months or less, which may not be adequate for total safety assessment. This study also demonstrated that a higher proportion of those that did require safety modifications were ones that may not have been given enough evaluation time to fully determine if warnings should have been in place from the very beginning.

For the study, researchers looked at the 222 novel therapeutics (183 pharmaceuticals and 39 biologics) that were approved by the FDA from 2001-2010. Over a mean follow-up period of almost 12 years, the following safety events occurred:

  • 3 had to be withdrawn from the market
  • 61 received boxed warnings
  • 59 needed “safety communications”

The mean time from when they were introduced for public use until one of these safety events occurred was only 4 years, which should add credence to the argument that longer study times may be needed to determine how truly safe some of these meds may be when long-term use may be required. People taking them after initial introduction are being exposed to possible risks before all safety issues have been clearly identified.

To emphasize that line of thinking were the results of the study that showed these were the drugs most likely to have one of the above safety events (look at the last 2):

  • Biologics (drugs that are derived, in some way, from living organisms)
  • Psychiatric drugs
  • Drugs receiving “accelerated approval”
  • Those that were approved close to their regulatory deadline

See a pattern? Again, if you choose to go the route of medications, there will always be some associated risk attached to it. (Name ONE medication that does not have a list of “possible” side effects). Some of the risks included serious skin reactions, liver damage, cancer and even death, as reported by the Associated Press. How comfortable are you with that?

Medications do save lives, and are necessary in some cases, but they are not mandatory as we get older and there are many healthy people that have been able to stay that way without the use of drugs. At age 47, I’m one of them and I plan on continuing that trend as long as possible. Our goal at our office is to help others achieve the same if that is the approach they choose to take with their health. Some people are looking to reduce the number of medications they are taking, others want to do what they can to never be on them in the first place.

How you take care of your body every day will be the biggest determining factor of where you will fall into that spectrum. If you are looking to adopt a more natural approach to your health, we invite you to schedule a Discovery Day with our office so we can understand where your health state is now, what you want to achieve, and to develop a plan to help get you there.

The odds of you getting healthier safely are definitely better than 2 in 3!




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