When you receive the wrong order at a restaurant, what do you do? Send it back. If you purchase a toy for your child and it doesn’t work, what do you do? Return it. If you go see a movie and the picture is bad, what do you do? Get your money back. We experience faulty products in many different areas of our lives and feel entitled to rectify it, so why should we accept drugs that fail to meet our expectations? I’m here to let you know that YOU DON’T HAVE TO.
The Food & Drug Administration (FDA) is responsible for the oversight of over 90,000 facilities. This includes manufacturing sites, laboratories, and storage facilities for pharmaceuticals, medical devices, cosmetics, and food. Whew! Needless to say, there are not enough people at the FDA to monitor every single batch of product that is distributed to the general public. To compensate for this, the FDA has established a set of laws or “final rules” that companies must follow and they conduct pop-up audits of facilities to make sure those rules are being followed. Yet, they don’t solely rely on the manufacturers to do their part. The FDA also provides means for patients to report problems when things aren’t as expected.
On July 10th, the FDA released a safety alert, warning patients of the dangers associated with the use of a specific type of antibiotics (fluoroquinolones). These antibiotics have been in use for 30 years, but after investigating the history of adverse events, the FDA discovered a trend of low blood sugar and mental health issues for specific patient groups using these products. Because consumers and physicians reported these issues to the FDA, they are now able to further protect the public by requiring the manufacturers to add warnings to their labels for those people who can experience significant side effects from these drugs.
So how do you report adverse events to the FDA?
MedWatch is the FDA’s voluntary reporting system for both doctors and patients. Some things that can be reported through this system are serious side effects, product use error, product quality problems, or therapeutic failure associated with pharmaceutical drugs, over the counter medicines, medical devices, nutritional products, cosmetics, and foods. Manufacturers are also required to report complaints through this system.
Please note that this is not the same system that I discussed in “When Vaccines Go Wrong”. Adverse events related to vaccines are reported through VAERS (Vaccine Adverse Event Reporting System).
The FDA’s mission is to protect the public health. They have a tremendous responsibility and in order for them to be successful, we also have to do our part. The system only works if manufacturers follow the rules, patients follow instructions, and everyone communicates when things go wrong. Demanding safety and effectiveness is your right. Speaking up is too.