Fluoroquinolone postmarketing is a fancy way of saying ‘findings on a drug that happen after a drug has been FDA approved for clinical use’. Postmarketing sometimes takes the form of formal research studies, but can also be simply a collection of anecdotes (personal stories) of those drugs that might include stories of Adverse Drug Reactions, lack of effectiveness, or even effectiveness for conditions the drug manufacturers did not know they were effective for. An example of that is that the drug Minoxidil was originally used to treat high blood pressure, but postmarketing research found that patients using it had improved hair growth, and voila, a hair-growth medication was created.
While some see the collection of mere anecdotes as unscientific and not true ‘postmarketing research’, most countries have a way for patients and/or health care providers to report adverse effects of drugs to the governing body that regulates drugs in that country. In the United States, this is the Food and Drug Administration Adverse Event Reporting System. The stories that the FDA receives are then, theoretically, used to determine policy based on the safety and usefulness of those drugs. So, the detractors who claim that mere collections of anecdotes cannot be considered ‘postmarketing research’ should tell that to their own governing body, who does the same thing!
Governments as the Problem or the Solution?
Unfortunately, the motives of these governing bodies are not always pure, and since they hold the power of government, can sometimes ignore the information collected in their adverse event reporting systems in favor of motives that are not necessarily in line with their mandates of public safety, including pandering to monied special interest groups. In the case of the FDA, a recent study entitled Institutional Corruption and the Myth of Safe and Effective Drugs outlines the failure of this agency to actually do it’s job. So, it’s possible that postmarketing surveillance by those on the internet may even be more accurate and useful than relying on governmental organizations to inform the public about these drugs.
Certainly, personal stories (anecdotes) should always be ‘taken with a grain of salt’ as they are not definitive proof of anything, and there are many biases and confounding factors that individuals do not take into account, and sometimes people are just incorrect or are even lying. However, collections of these personal stories can sometimes give us interesting information.
Because drug studies are often limited in scope and use small numbers of people, often using classes of people who do not represent the classes of people who get the drugs in real life once they are approved, post-marketing information often sheds vital information on the safety and effectiveness of drugs. In the case of the Fluoroquinolone drugs, postmarketing research has been instrumental in finding serious and even deadly conditions that were not found before the drug was released. In fact, at least 7 Fluoroquinolone drugs have been completely removed from the market, with several having their use limited only to life-threatening illnesses where the drugs will be given in hospitals.
Remember, post-marketing means that the drugs had been approved for use, but then information was discovered later in which the same governing body that approved them, then found them so dangerous that they were then removed from the market. They said the drugs were safe, then a lot of people were so badly hurt that they changed their minds and determined they were NOT safe. In other words, the drugs should never have been approved in the first place because they were too dangerous!
You’re Part of a Fluoroquinolone Postmarketing Experiment
For many years, we have warned patients not to use newly approved drugs unless they are one of the decided minority of new drugs with evidence that they provide a breakthrough beyond existing treatments.
The estimated probability of acquiring a new black-box warning or being withdrawn from the market over a period of 25 years was 20%. Half of these black-box warning changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.” [emphasis is from the original text]
Pages that we will link to in the future will contain many of the postmarketing research done on the Fluoroquinolones, either by researchers, government agencies, or reputable sites found across the internet. If you know of others, please include them in the comments below so they can be added to the list.
If you are interested in learning more about the Fluoroquinolones and how to recover from these damaging drugs, we recommend getting The Fluoroquinolone Toxicity Solution. We have worked closely with the authors and were helped immensely by this book and the personal attention we received from them. After spending over $25,000 on doctors and treatments that did not work, we began following the protocol and recovered function more than doing anything else we tried. We do receive a small commission for each book that sells through the links on our site, and we hope that, if you do choose to purchase this book, you’ll purchase it through our link to help us keep this site running and support our efforts at continuing to educate about the Fluoroquinolones, and help those who were damaged by them. We recommend the book because it worked for us and many others we’ve spoken to, and we highly value the information it contains.