What is FQAD?
According to the FDA, a new warning is needed for Levaquin, Cipro, Avelox and other fluoroquinolones (FQs) as they may trigger a serious, persistent, multi-symptom disability referred to as fluoroquinolones-associated disability (FQAD). FQAD refers to a “constellation of symptoms” leading to disability that have been observed during FDA monitoring of FQ safety reports.
Although most of the individual symptoms observed are documented in literature and reflected in the FQ drug medication guides, there have been no warnings in the past about a link to a constellation of symptoms across organ systems.
Case Studies seem to indicate that individuals experience FQAD symptoms differently. However, a diagnosis with this disability requires the following:
- A previously healthy patient who was prescribed a course of FQs for the treatment of one of the following:
- Uncomplicated sinusitis
- Urinary Tract Infection (UTI), or
- Another illness that would likely resolve itself without antibiotics
- Symptoms relating to at least two different body systems, including:
- peripheral nervous system,
- musculoskeletal (including tendon rupture and tendonitis),
- cardiovascular, and/or
- Symptoms need to have been reported to last 30 days or longer after stopping the FQ treatment.
Symptoms May be Progressive and Delayed
Case studies note that while some symptoms may appear during the FQ course of treatment, it is not unusual for some individuals to present symptoms linked to FQAD appearing months after treatment has stopped. In addition, some symptoms progressively worsen over time.
Failure to Warn of the Risk of FQAD
The FDA has received more than 50,000 reports of adverse events and 2,600 reports of deaths associated with Levaquin, Cipro, Avelox and Factive, through June 30, 2015. According to FDA estimates only about ten percent of all adverse events are actually reported to the FDA, as these are voluntary reports. Furthermore, in the case of FQAD, most consumers and many doctors were not aware that there could be a link between a delayed symptom and a FQ course of treatment. Therefore, it is possible that the number of adverse events that were actually related to FQ treatments are more than ten times as large as currently report.
THL believes that the manufacturers of FQs should have warned the public about the risk of FQAD - a persistent, progressive and serious disability that has been shown to be a substantial disruption to a previously healthy individual’s ability to conduct a normal life.
THL has set up a website with more information about FQAD in order to help individuals affected determine their legal rights. Visit www.FQADLawsuit.com for more information.
For years, activists and researchers have been trying to get word out to the public about the risks that these popular billion dollar drugs carry with them. Many critics have been public about their belief that FQs, including Levaquin, Cipro, Avelox and Factive (as well as the six other FQs that were removed from the market) are over-prescribed and they should be reserved for conditions in which other effective antibiotics are not available.
If you or a loved one has experienced symptoms that may be classified as a disability as a result of FQ treatments, we encourage you to call the FQAD lawyers at THL for a no charge/no obligation discussion about your legal rights.