CHARLOTTE, N.C., Sept. 26, 2016 /PRNewswire-iReach/ -- The Food and Drug Administration (FDA) strengthened warning labels on July 26, 2016 and issued a limitation-of-use directive on fluoroquinolone antibiotics. These antibiotics, which include Levaquin (levofloxacin), Cipro (ciprofloxacin), and Avelox (moxifloxacin) can be associated with severe and often permanent adverse events, also known as fluoroquinolone-associated disability (FQAD).
When a medication is proven to be associated with risks, the FDA or drug manufacturer communicates with healthcare providers across the country via Dear Health Care Provider (DHCP) letters, also known as Dear Doctor letters, intended to alert physicians and other health care providers about important new or updated information regarding a human drug or biologic.
Unfortunately, Dear Doctor letters have not been issued for fluoroquinolone antibiotics, and the strengthened warning statements are not reaching prescribing physicians, leaving many patients at risk.
The Quinolone Vigilance Foundation (QVF), an international non-profit, took matters into their own hands. The organization composed a Dear Doctor letter which they will distribute to doctors themselves.
"There is a definite disconnect between the FDA, drug manufacturers, and patients. We hope that this project can bridge the gap so that patient safety is a priority," says Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation. "Unfortunately, the message about the disabling adverse events associated with fluoroquinolones is buried in an FDA press release and the information never reached doctors via Dear Doctor letters, leaving many patients and doctors unaware of the harm fluoroquinolones like Levaquin, Cipro, and Avelox may cause."
"Strengthening safety profiles on powerful, potentially dangerous medications is a step in the right direction. But it doesn't do much good if that information isn't reaching prescribing physicians. I fear for patient safety if doctors are not aware of the risks." continued Brummert.
The Quinolone Vigilance Foundation began the project this summer, and plans to have it completed by early 2017. Brummert noted that the current strategy of conveying the message in press releases is ineffective at reaching the appropriate audience in a timely manner. "We have been pushing for safety label warnings and communicating risks to physicians for a long time and we decided that patient safety is too important to wait for the FDA and drug manufacturers to take action."
Chris Butler, Vice President of QVF affirms, "While the FDA has finally admitted the risks of the adverse events of fluoroquinolone antibiotics outweigh the benefits, they have not taken appropriate action to notify the general public or physicians. The FDA believes a press release on their website is sufficient to warn doctors and patients. Those press releases can be buried in a few days and the doctors will never know of the updated Black Box Warnings. Patients and doctors have a right to know the dangers associated with these antibiotics".
Brummert and Butler hope that by issuing the Dear Doctor letters through the Quinolone Vigilance Foundation, the important information contained in the new FDA labels will reach a broader audience.
Unfortunately, fluoroquinolone-associated disability is a global problem, not just a national one.
Donna Schutz, Assistant Director and Australia Ambassador for QVF, states, "Australia is facing the same issue with most doctors being unaware of the serious warnings on fluoroquinolones. Even though Australia has stricter guidelines on the prescribing of fluoroquinolones, many Australian victims were not warned and their doctors believe fluoroquinolones are safe."
"It can often take years for FDA warnings to be updated by the Therapeutic Goods Administration (TGA) in Australia. It is our hope that we will be able to expedite notifications and keep patients safe from dangerous antibiotics", Schutz adds.
Fluoroquinolones, in oral, IV, and topical forms are meant as a last resort for life threatening infections such as anthrax, plague, and serious cases of bacterial pneumonia. As little as one drop or one pill can cause adverse events hours, weeks, months or longer after administration. Therefore, it is imperative that doctors and patients are made aware of the serious risks.
About The Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org- is an international non-profit, charitable foundation headquartered in Charlotte, North Carolina, that helps raise awareness about fluoroquinolone antibiotics and their dangers among patients and medical professionals, and funds independent research on fluoroquinolone-associated disability.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, firstname.lastname@example.org
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