Antidepressant labels to carry new warning of life-threatening side effect

The FDA has ordered a wide range of antidepressants to carry new warnings of an unusual but potentially deadly side effect seen most often in the first few weeks of treatment or when a patient increases dosages. The labels of two classes of new-generation medications for depression -- selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) must now notify patients that malignant neuroleptic syndrome has been linked to the use of these drugs.

Among the drug companies ordered to revise their labels to alert patients of the danger were those making Celexa, Cymbalta, Effexor, Lexapro, Paxil, Pexeva, Pristiq, Prozac, Venlafaxine and Zoloft. The orders were dated Feb. 4, but disseminated this morning in a public notice of FDA actions.

In malignant neuroleptic syndrome, patients experience muscle rigidity, extreme variations in body temperature and wild fluctuations of heart rate and blood pressure -- all signs of malfunction in the body's autonomic nervous system, which regulates involuntary body functions. Malignant neuroleptic syndrome has been associated with older antipsychotic medication such as haloperidol, lithium salts and risperidone. But the widespread use of SSRI and SNRI antidepressants has made this syndrome a more common and visible affliction.

With one in 10 Americans taking prescription antidepressants, medicines such as Zoloft, Prozac and Effexor are currently the most commonly prescribed class of drugs in the United States, just ahead of high-blood pressure medicine, according to the Centers for Disease Control. And SSRIs and SNRIs have become by far the most common types of antidepressant dispensed by pharmacies, driving a tripling of prescriptions since 1988.

Malignant neuroleptic syndrome is a rare but extremely dangerous condition that results in death in, by some estimates, 10% to 20% of cases. Until recently, it was so uncommon it was unlikely to be recognized in many emergency departments. But the widespread use of SSRIs and SNRI antidepressants had made this bizarre syndrome a more common affliction seen in emergency departments.

A Food and Drug Administration spokeswoman said this afternoon that she had not been notified of the labeling change and was unaware of what led to it. Watch this space.

-- Melissa Healy

Comments

[Arnold Kaplin MD]

I wish the news had better clarified that the incidence of "10 to 20%" referred to THAT percentage of the "RARE" cases that occurred--NOT "10 to 20%" of SSRI/SNRI users.......!!!!

[sandy]

I had this many trips to several emergs and clinic did not get me a diagnosis doctors were not aware of it. I have sufferred huge losses in health and it has ruined my life.

"Until recently, it was so uncommon it was unlikely to be recognized in many emergency departments"

I would like to know what recourse there is for people like me who haved suffer huge losses because this information was not available? Why has it taken till now to know about this are these drugs not deemed safer by the FDA?

I would like to see follow up stories re: why it has taken so long for this information to be presented? What of drug trials why were these problems not reported before the drugs were approved?

I suspect the 10/20% guess will come in way low once the emerg docs are properly diagnosing. Like other rare problems reported with this type of drug they are suddenly wide spread like withdrawal which I might add is horrendous.

If you are a person currently in withdrawal from an antidepressant you can get information and advice from these two sites.
paxilprogress.org
effexoractivist.com
There may be other sites but I am not aware of them all. Good luck you will need it.

[Ajlouny]

Doctors need to ensuring these medicines are used well and risks to patients are minimized. If patients are prescribed an anti psychotic, it should be a very low dose for the shortest period necessary.

[Janet Saugstad]

Emergency room docs don't want to appropriately diagnose this devastating side effect. Keeping it very rare doesn't affect sales of these horrid meds.

I once had diverticulosis and fibromyalgia. Both are side effects of SSRIs, about which doctors feign ignorance. I stopped taking any antidepressant 13 years ago and haven't had any chronic pain since then. When your bowel goes into spasm as is true with diverticulosis, it can be incredibly painful. Also, irritable bowel syndrome is ancient history.

The fibro went away within six weeks of stopping my SSRI, which I was encouraged to take when I became a rape victim. Americans in the recent past have gotten through rape, Civil War, and other violent acts, without these meds that really make everything so much worse.

Doctors don't like me when I refuse their meds. Tough nougies.