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

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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
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