Perilous Pills author, Marilyn Beardsley Heise sent Letters to the Editor at the Portland Press Herald about FDA Black Box Warnings and Hospital Overprescribing. Both were printed. One elicited a surprise response.

Read them here:

OK of ‘black box drugs should draw scrutiny
April 5, 2022

The Food and Drug Administration’s rush to approve new medications 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 commonly-prescribed antibiotics includes Levaquin and Cipro as well as many generics.  FDA approved them in the 1980s for serious or life-threatening bacterial infections and cautioned against giving them to the elderly. However, millions of these pills are prescribed worldwide every year off-label for less serious illnesses such sinus infection, or even Covid, a virus, which they are not even effective against. Still, they have caused disabling adverse events and even death to hundreds of thousands of patients in the U.S. alone, not to mention worldwide where use is also widespread.  U.S. events are documented at the FDA’s own MedWatch site, where only 1 percent to 10 percent are reported, according to the agency.

Since approval, the FDA has issued seven medical alerts for fluoroquinolones called “black box warnings.”  These were sent to physicians and medical institutions warning that fluoroquinolones could cause rupture of the Achilles tendon, tearing of the rotator cuff, retinal detachment, peripheral neuropathy, seizures, aneurysms, aortic rupture, suicide and more.  Some patients have experienced lifelong injuries. As a result, in 2015, the FDA recognized Fluoroquinolone Associated Disability (FQAD) 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 cause. 

Why aren’t we asking the FDA why it is approving drugs that need so many follow-up warnings about incredible injuries and even deaths that they may cause?

 

Marilyn Beardsley Heise
Author, “Perilous Pills: Protecting
Yourself from Fluoroquinolone Injury

Overprescribing fuels opioid deaths
July 31, 2022

[Photo of OxyContin pills with caption: A reader says her recent experience at a Maine hospital shows that these powerful painkillers must be prescribed with more consideration.]

There is another reason why people are dying from opioids (Our View: “Overdose deaths driven by dangerous supply,” July 17). It is well-known that many unsuspecting patients have become hooked because they were prescribed these powerful painkillers by their doctors or hospitals.  Not only prescribed, but over-prescribed. 

After a recent small surgical biopsy at a respected Maine hospital (Central Maine Medical Center, Lewiston), I was sent home with a prescription for 55 opioid pills! There was no discussion about this drug or pain evaluation before discharge. I took two Excedrin that night and I was done with any discomfort.

This kind of overprescribing became common after pharmaceutical companies pervasively and persuasively marketed these meds as the latest and most effective pain killers. Physicians and institutions responded and prescribed them by the millions. 

The Editorial Board states “As the deaths mount with no relief in sight, we can’t reject ideas that could save lives.”  How about this idea?  Hospitals and doctors must stop the overprescribing of these potent drugs which can lead to devastating addiction and death. 

Marilyn Heise,
East Boothbay

 

This reader responded.

Unneeded prescriptions add to costs, dangers
Portland Press Herald, Letters to the Editor — August 7, 2022

I just finished reading Marilyn Heise’s July 31 letter to the editor, “Overprescribing fuels opioid deaths”) and had to chime in with my own experience.

I had minor internal surgery over a year ago at Maine Medical Center in Portland. I awoke feeling really good. The doctor gave me all the usual post-surgical advice, and a prescription for oxycodone. I told him emphatically that I did not want them, nor would I take them.

He kept pushing it because I might need them after getting home, and I again said “no.”  When my daughter picked me up, I had a paper bag in with my belongings that I didn’t notice, but you guessed it – a bottle with 10 pills in it!

I am still irate just relaying this. Think of the costs for every patient routinely getting these unnecessary and dangerous pills! I then had to find out a safe way to get rid of them. When will the doctors hear and respect the patient!

Rosemarie Fitch,
New Gloucester