How safe is my medicine?

By: Brad Tripp

            He’s rushed into surgery, blood everywhere, his left arm sitting on his bed in a cooler. Going into shock, he mumbled, ‘the saw, the tree…” before finally slipping into a coma. The surgeons work hard for many hours and the limb gets reattached. The next morning, as his family gathers around him, the nurse comes in to check his pulse and to decrease his morphine. If not for many medications this man may not have lived and if he had he would be in excruciating pain.  Before any of these pills could be taken, however, the Food and Drug Administration (FDA) studies, tests and approves/denies each and every medication.

            What are the steps to getting a medication approved for human consumption? The FDA has a 12 step procedure towards approving any new medicines. According to fda.gov, the first step is to test the drug on animals. Next, the purposes are investigated and listed for the drug. Following this the drug is then tested on people, usually a small controlled group of about 20-80. The forth step is to make the group larger, consisting of a few dozen to about 300 people. It is then tested on a few hundred to about 3000 people. After this the FDA and the recipient of the new drug application (NDA) meet. This is when the NDA is sent to the FDA. The FDA now has 60 days to approve the new drug. After the 60 days, if the FDA files the new drug there is then another group of people assigned to test and evaluate the drug on its safety and effectiveness. The contents and labeling are then inspected, along with the facilities where the drug is manufactured. Now the drug is officially approved and produced worldwide.

            Medicines are typically well tested on animals and people before they are shipped out and sold to the average consumer. Every year, there are many drugs that go through the FDA process and are approved. According to Fda.gov, of the drugs approved this year, two of them include Hetlioz, a treatment for the 24 hour wake disorder in blind people, and Farixiga, a treatment for glycemic control (along with diet and exercise) for adults with Type 2 Diabetes. According to centerwatch.com, a site that monitors newly approved medications, other medicines released as of 2014 include Imbruvica, a treatment for lymphatic leukemia, and Vimizin, a treatment for Mucopolysaccharidosis.

            All in all, there are many medications for many reasons. Always try and find the FDA label on the packaging, as these medicines are well tested and fit for human consumption.