Government agencies like the United States Food and Drug Administration (FDA) were put into place to protect the public. But what happens when that agency fails to do its job; when they and the companies they are supposed to regulate begin to view the public as a statistic?
Does the FDA Really Protect the Public?
Recently, investigators from ABC News looked into the FDA’s failure to disclose the serious side effects of Levaquin to the public. Part of the fluoroquinolones drug family, it is also marketed under the brand name Cipro, and the generic name Levofloxacin. Commonly used to treat severe infections, like pneumonia and kidney infections, the drugs are so powerful that they are even used to treat anthrax.
Since 2008, the FDA has placed a “black box” warning on the drug—its highest possible warning level—over its potential to cause ruptured tendons and/or nerve damage. What has not been disclosed is that the FDA has also investigated Levaquin for possible mitochondrial toxicity.
Mitochondria are small structures within cells. They act as powerhouses, providing the cell with energy. Mitochondria toxicity decreases the number of mitochondria in cells, stripping them of their energy, thereby decreasing the cell’s ability to function properly. If enough mitochondria are damaged, cells begin to die. This can lead to a number of complications, including numbness in the fingers and toes, inflammation of the pancreas, loss of energy, organ failure, and even death.
With side effects so severe, why would the FDA not notify the public of the risks behind taking Levaquin? While recent studies may not give an answer, they do indicate this is not the first time the FDA has failed to protect the public from Big Pharmaceutical.
FDA Failures Mean Grave Consequences
According to a study published in JAMA Internal Medicine the FDA failed to publicly disclose official actions taken against 57 clinical trials. Twenty-two of them included “falsification.” Even more concerning is that, when forced to reveal details after being presented with freedom-of-information requests, the FDA continued to hide some of the important details about those trials. And there are other studies that indicate that not all drugs even make it through the complete, basic reports of filing adverse effects with the FDA, yet they are prescribed to patients.
The FDA’s own reports also state that 3,000 people have died from the drug Levaquin. They have received another 200,000 other complaints relating to the drug’s serious side effects. Yet, the public has not been notified; not even the physicians prescribing these defective drugs have been informed of the dangers to their patients.
Patients are Not Statistics
So, who is paying the consequences for the defective drug product liability happening with Levaquin? It is not Big Pharmaceutical, and it certainly is not the FDA. It is the general public, the thousands of people actually taking the drug. That is not how it should be.
We believe drug manufacturers and organizations like the FDA should be held accountable when they purposely conceal important side effect information, especially when those side effects cause loss of life or loss of vitality in life. If you or someone you love has been affected by Levaquin, or any other defective drug, contact our experienced Chicago defective drugs attorneys for a free consultation.
