Are the patient handouts that come with the Fluoroquinolone drugs misleading the public about the safety of these drugs? Public Citizen thinks so, and did something about it. Along with a doctor, pharmacist, and an attorney, they crafted a petition to the US Food and Drug Administration urging them to regulate these handouts in the name of public safety.
The package inserts that come with most drugs can often be dizzyingly complex and include a list of side effects so long as to be useless. These Patient Information Leaflets, or PIL’s, are crafted by the drug manufacturers and given to patients in an attempt to give them the most pertinent information they need to know, such as how best to take the drugs and the most important problems they should note. While this may seem like a good idea, Public Citizen has found that these handouts might be doing more harm than good and putting the public at risk.
The Fluoroquinolones were no exception, with the petition outlining a peer reviewed study published in the Journal of the American Pharmaceutical Association that discovered,
“the content of four categories of information in PILs for five fluoroquinolone antibiotics ( drugs such as ciprofloxacin (Cipro) and ofloxacin (Floxin)) were compared to the information given in the approved product labeling for these drugs (package insert). The information content of the fluoroquinolone PILs contained less than one-half of the information listed in the approved product labeling for these drugs.”
Read HRG Publication #442 here, which is Public Citizen’s PETITION TO IMMEDIATELY STOP THE DISTRIBUTION OF DANGEROUSLY MISLEADING PRESCRIPTION DRUG INFORMATION TO THE PUBLIC