Is anyone really on watch?

Last Friday I told you about the FDA’s “watch list.” It can be a sham. And it usually amounts to nothing more than a slap on the wrist for the drug company.

This appears true with Celexa, a popular antidepressant. We know it can cause real harm. And the FDA knows it can contribute to dangerous heart problems. Yet it remains on the FDA’s watch list. And it also remains, not surprisingly, on the market.

The problems with Celexa started to come to light a few years ago. But the FDA has done very little to restrict the sale of the drug. Eventually, Harvard researchers had seen enough. They began to study the drug themselves to determine its real dangers.

I’ll tell you all about what the Harvard researchers discovered, but first let me back up for a moment.

Citalopram hit the market in 1989 for the treatment of major depression. Today, Forest Laboratories sells it in the U.S. under the brand name Celexa. It belongs to the new class of antidepressants called SSRIs. These drugs increase the amount of serotonin in the brain.

Celexa works like other SSRIs in its class. But with one key difference. In addition to the usual side effects associated with most SSRIs, such as weight gain, Celexa appears to increase the risk of serious cardiac arrhythmias. This is similar to the risk associated with the dangerous, old antidepressants. But the new SSRIs were supposed to represent an improvement over those older, more dangerous SSRIs.

The FDA knows about this serious risk associated with Celexa.

Last year, the agency warned patients not to take high doses of the drug. But the punishment hardly fit the crime. And it left patients and doctors scratching their heads about the popular antidepressant. Is it really that dangerous? Should patients still take it? When does the trouble begin?

That’s why the Harvard researchers stepped in. They wanted answers to these questions. And of course, the FDA did not provide them.

Dr. Ray Perlis, of the Department of Psychiatry at Massachusetts General Hospital (MGH), lead the research into Celexa.

He said, “It was important to confirm the effects of citalopram–one of the most widely prescribed antidepressants in the U.S.–because the FDA warning really gave us minimal clinical guidance. The impetus for this study came directly from the phone calls we received from colleagues and from patients taking citalopram asking what they should do. We realized that to get a satisfying answer, we needed to get more data.” 

At least Dr. Perlis recognized that getting “minimal clinical guidance” from a government bureaucrat is a risky proposition at best. Of course, under Obamacare, having to obtain approval, let alone “clinical guidance,” from a government bureaucrat is about to become the new reality for doctors and patients.

So, the good doctors at MGH listened to their patients. They listened to their colleagues. And they wanted to get a better idea of the real world heart problems they kept hearing about with Celexa.

Of course, the drug companies should have done this work. And the FDA should have demanded it of them. And the work should have been done long before they ever released the drug on the unsuspecting public. Especially given the history of the older antidepressant drugs.

To get to the bottom of the problem, doctors from MGH began to analyze  medical records for more than 38,000 hospital patients. They looked at patients taking one of 11 different antidepressant drugs and compared them to patients taking methadone, a drug known to prolong QT interval.

A QT interval is the time from the beginning of electrical activation of the heart to the end of electrical relaxation. We know with certainty that many medications–including older antidepressants–increase the QT interval. Methadone also prolongs the QT interval.

Most people who get QT prolongation have no heart rhythm abnormalities. However, it is a recognized risk factor for a dangerous heart arrhythmia called torsades de pointes. In French, this literally means, “twisting of the points.”

The patients also had EKG readings taken between two weeks and three months after receiving a prescription for these drugs.

The Harvard researcher confirmed the FDA’s warning. Higher doses of Celexa are strongly linked to a prolonged QT interval. The study also confirmed the link between a prolonged QT and methadone. They also linked the older antidepressant drug amitriptyline with a prolonged QT.

In a bit of a surprise, the researchers also uncovered a new problem drug. They found a link between prolonged QT interval and the latest and greatest antidepressant drug, Lexapro (escitalopram).

As I explained last month in my Insiders’ Cures newsletter, all drugs affect the body. An axiom of pharmacology is that “any drug can have any effect.” But an increased QT interval is one effect you don’t want in a drug.

We have known for decades that the older tricyclic antidepressants such as amitriptyline can cause sudden cardiac deaths. Today, some psychiatrists still prescribe these drugs, even though they are strongly associated with sudden deaths!

I investigated such cases as a Medical Examiner. In these victims, I found the characteristic “myocytolosis” in the heart muscle. This literally means the heart’s muscle cells dissolve.

No wonder patients can experience heart abnormalities. Knowing the dangers of the older drugs, how can this come as a surprise with the wonderful new generation of antidepressant drugs?

In the Navy, if you slept while on “watch,” you could be executed for dereliction of duty. But when the FDA “watchers” are derelict, it is the patients who can die!

And here’s the bigger issue…

Why is any drug the first-line choice for mood disorders? We know that for mild to moderate depression, behavioral and talk therapies work far better. And are much safer.

In the April issue of my newsletter, Insiders’ Cures, you will get the full story about antidepressants–their scandalous use and outright abuse. You’ll also learn about how to help protect yourself and your loved ones without suffering in silence. If you don’t already subscribe to my newsletter, you can get started here.

1. BMJ2013;346:f288