Letter to the editor: FDA approval of 'black box' drugs should draw scrutiny – Press Herald

Sign in or Subscribe See Offers

The Food and Drug Administration’s rush to approve new medications (“Another View: Long-term studies of approved medicines needed,” March 27) is only one important issue that should be addressed concerning Washington’s drug regulatory agency. The FDA is part of the federal Department of Health and Human Services, and yet its decisions are not always so healthy.
Take fluoroquinolones, for example. This powerful class of antibiotics includes the commonly prescribed Levaquin and Cipro as well as many generics. FDA approved them in the 1980s for serious or life-threatening medical conditions. However, millions of these pills are prescribed worldwide every year off-label for less serious illnesses, although they may cause disabling adverse events and death to hundreds of thousands of patients in the U.S. alone. Such events are documented at the FDA’s own MedWatch site, where only 1 percent to 10 percent are reported.
Since approval, the FDA has issued seven medical alerts for fluoroquinolones, called “black box warnings.” They have cautioned physicians that these antibiotics can cause rupture of the Achilles tendon, tearing of the rotator cuff, retinal detachment, peripheral neuropathy, seizures, aneurysms, suicide and more. Some events may be irreversible. In 2015, the FDA recognized fluoroquinolone-associated disability as a syndrome.
Unfortunately, black box warnings are rarely read by doctors, making them less than effective. Losers are patients, who take their medicines unaware of the unnecessary harm they might produce.
We should be asking the FDA why they are approving drugs that need so many follow-up warnings about the incredible injuries and even deaths they may cause.
Marilyn Beardsley Heise
author, “Perilous Pills: Protecting Yourself from Fluoroquinolone Injury”
East Boothbay
Success. Please wait for the page to reload. If the page does not reload within 5 seconds, please refresh the page.
Enter your email and password to access comments.
Forgot Password?
Don’t have a Talk profile?
Hi, to comment on stories you must . This profile is in addition to your subscription and website login.
Already have one? .
Invalid username/password.
Please check your email to confirm and complete your registration.
Create a commenting profile by providing an email address, password and display name. You will receive an email to complete the registration. Please note the display name will appear on screen when you participate.
Already registered? to join the discussion.
Only subscribers are eligible to post comments. Please subscribe or login to participate in the conversation. Here’s why.
Use the form below to reset your password. When you’ve submitted your account email, we will send an email with a reset code.
Send questions/comments to the editors.

“use strict”;
var date = new Date();
var cookieString = “MSPAN_Paywall_user=0; domain=.”+document.location.host.replace(/^w+./, ”)+”; path=/; expires=” + date.toGMTString();
var cookieString2 = “MSPAN_Paywall_user=0; domain=”+document.location.host+”; path=/; expires=” + date.toGMTString();
date.setHours(date.getHours() – 1);
document.cookie = cookieString;
document.cookie = cookieString2;


Add a Comment

Your email address will not be published. Required fields are marked *