New Antidepressant Warning Sought

FDA Says Drug Labels Should Warn Of Increased Suicide Risk For Young Adults

(CBS/AP)  Treatment with antidepressants increases the risk of suicidal thoughts and behavior in patients up to age 24, according to proposed changes to the drugs' labels unveiled Wednesday by health officials.

The proposal would expand a warning now on the labels that applies only to children and adolescents treated with the drugs.

The Food and Drug Administration put forth its plan to update the drug labels at a meeting of outside advisers convened to discuss the issue. The changes also would include a recommendation that patients of all ages be carefully monitored, especially when beginning antidepressant treatment.

In emotional public testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for more warnings on the drugs.

Ellen Hanson said her husband, Scott, hanged himself in 2004, weeks after he started taking Paxil. No one ever told the couple about a suicide risk before the 43-year-old union carpenter began taking the antidepressant, Hanson told the panel.

"I know he didn't want to be dead. Even two years later, I feel his death was an accident — a medical accident," she said.

But FDA advisers also heard from big believers in antidepressants, reports CBS News correspondent Sharyl Attkisson.

"Antidepressants gave me back my life and probably very well saved my life," said Sherri Walton of the Mental Health Association of Arizona. "Because who knows as I was spiraling downward what could've happened."

Mental health experts also are worried that additional warnings about the risk of suicides linked to antidepressants could curtail their use and ultimately do more harm than good.

The proposed changes come on the heels of an FDA review that found use of the drugs may increase the risk of suicidal thoughts and behavior among young adults ages 18 to 24, as in younger patients.

But expanding the "black box" or other warnings on the drugs could scare away doctors, parents and patients, mental health experts caution. They warn that people with untreated depression — about half of those who suffer from the disease — face an estimated 15 percent greater likelihood of death by suicide.

"My concern is that by not simply promoting good standards of care and by putting on a black-box label, the FDA may unwittingly limit further access to care," said Dr. Carolyn Robinowitz, president-elect of the American Psychiatric Association.

Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients.

Overall use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told panelists.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of "Prozac Backlash," said expanding the warnings wouldn't scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a mass review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results are analyzed by age, it becomes clear there is an elevated but short-term risk for suicidal thoughts and behavior among adults 18 to 24 that approaches that seen in children, the FDA said in documents released before Wednesday's meeting of its psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.

Multiple psychiatrists testified that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 — and an increase in suicides in that age group.

In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults and added that to the drug's label.

[gaye5]

Randal, this man and many others scan papers world wide, and other places for information. Unfortunately they find it very hard to find any good in regards Islam, so there is article after article on such, and you can make comments yourself.
He is a very learned man and has spoken on many talk backs, TV stations, polies etc...His knowledge is incrediable, and having lived in the middle East (as a non-Muslim) and with his knowledge and studies he has much to offer.

[randalds]

I'll check out jihad watch. Who knows, maybe if I start looking at more sites with a mid-eastern type name then maybe Cheney will start monitoring my phone and email. For liberals that's considered a badge of honor! ;-)

[gaye5]

Randal, you are funny, married three times and nothing scares you anymore, eheheheh... marriage is precious but it sure is hard if the partner expects the other to think like they do...
Randal, I agree with you once again, but both left and the right use scare tactics as they know it will work, and once the people become immune these horrors not being true the people will give up and polies know that they can do anything without interference.
I suggest however that you might like to look at other news like Jihad Watch, or honest reporting, MEMRI and there are others, they give a different perspective on things, and are not out to manipulate... They depend on donations, they are not controlled by ????... and I gather the researcher for Jihad Watch came from the middle east.. and has written many books...
There is much much more than we are being told by the media, so much that it is like murders where there are so many that they dont bother to report them... Terrorism is not a problem YET...

[randalds]

Actually Gaye5 I think it's about time that we, except for some obvious security measures, ignore them. The republicans have used terrorists to try to scare people more then the terrorists themselves have. You have a 10x more likely chance of being stung to death by killer bees then even being involved in a terrorist attack, let alone hurt or killed. That's not to say there won't be more attacks, but let's have some perspective here. I'm more worried driving on the 405 then I am about a terrorist attack. Besides, I've been married 3 times and nothing scares me anymore. ;-)

[gaye5]

RandalDS and Some of you have talked about .....the constant preaching of fear, fear, fear. Al-Qaeda is out to kill you! Terrorists want you dead! Assam bin Laden is under your bed! Saddam hussein wants to blow you up! Watch out for the boogieman! Wrap your house in plastic and duct tape! Anthrax! Poisoning! Be afraid! Be very AFRAID!
And you are right, but remember this is what the Quran says, terrorise first as a terrorised people are weakened and easier to conqure then invite to Islam, and if they refuse, slaughter...
It is about time that instead of talking, talking, appeasing etc that our governments did something about this war that they have started on us, we must stop this terror or we could all suffer...

[randalds]

Add to that the constant preaching of fear, fear, fear. Al-Qaeda is out to kill you! Terrorists want you dead! Assam bin Laden is under your bed! Saddam hussein wants to blow you up! Watch out for the boogieman! Wrap your house in plastic and duct tape! Anthrax! Poisoning! Be afraid! Be very AFRAID!



Oh and while you're at it, take a pill and vote republican.

[randalds]

No ncolsens, not just Bush, but you must admit these are very depressing times in general. I don't know anyone who's enjoying the war, the deaths or the economy. Everyone is under more pressure then ever before and that has to have an effect on susceptible people.

[docpeter-2009]

RE: samgman, being a licensed chiropractor I will offer a small defense here. Could it be that patients that go to the chiropractor are always offered a treatment plan because they are in pain? Why else does a patient go to any doctor? Do you go to the doctor when nothing appears to be wrong or are you more likely to go when you have problems?

Of all the health professions I have no respect for psychiatry. This is the one health profession where "its all in your head". It is one profession where there is no demonstratable cause of disease and the "cure" takes a lifetime of medications and weekly counseling sessions. At least most chiropractors can demonstrate through their exam and x-ray findings the causes of your problems.

Don't get me wrong here, I do agree that there are many who are helped by the counseling and helped by being given the time and ability to discuss and work their way through their problems, but many are "hooked" into believeing they need these weekly sessions and drugs. Yes there are also many who are "hooked" into believing they need weekly chiropractic treatments also, when they don't. Most of the patients I treat are on an as needed basis, come in when you feel you need my help. The new patient is likely to get more treatment until we can get them "over the hump" of their pain and discomfort, but after that they come in only when they feel they have soemthing out of place and need additional care.

I've never known anyone to visit a chiropractor without receiving a prescription for treatment.

Likewise, I've never known anyone to visit a psychiatrist without receiving a prescription for anti-depressants.

Both chiropractors and psychiatrists perform a valuable service that have helped many. What I don't believe is that everyone needs their services.

I don't like Bush anymore than the next guy but but you can't put this one on his head, give me a break.....

[randalds]

Maybe anti-depressant use has gone up because of who we have for president. I'm not kidding. This administration has used fear and hate and divided America into two armed camps that can't stand each other. Plus we're in a war. Thousands are dying. There's hate and tension across the country. Just read these blogs to see how much conflict has come up in the past 6 years. No wonder more people want to be medicated.

[gaye5]

Don't get me wrong, along with the thousands who die every year from drugs, many drugs have also done miraculous things and save thousands of lives, there has been great strides done in this line, but I object when these same people tell us that the natural things are bad for us when thousands of people have been healed from taking natural products and are alive ten or more years later, after Dr's have given up .... and the medical profession and pharmaceutical companies still wont look at facts they just continue to try to destroy all natural companies. We have to realise that it is probably because Pharmaceutical companies and Dr's don't make money when a cure is natural, and they would rather allow the people to die than loose out on their billions... look on the net at "The Pharmaceutical drug racket", to see how things fair. Of course their will be manipulation to discredit things so as we dont know what is right or wrong, but the proof is in that the fourth cause of death in America is drugs and Dr's...

[gaye5]

Imagine if this was a natural product, it would be taken off the market within a day and the world would know how bad it is... Here in Australia we had a company which was destroyed because a few people had a reaction to an ingredient to one of their natural calming products. Strange how this very same ingredient is still in over the counter pharmaceutical products, and of course there is more to the story but it still doesnt add up.
One would have to wonder if in fact there is any research done on many of these products when we consider that pharmaceutical drugs and Dr's are the fourth cause of death in America (and that is not counting the thousands who are permanently damaged), but still these Pharmaceutical companies are allowed to continue producing these pills and nothing is done about it. If they do take the drug off the market after thousands have died, it is often just re-market under a different name. Hmmm...

[kaliveotin]

Most anti-depressants are extreemely dangerous in some people. Many people are extreemely dangerous when withdrawing from these pills. (and since they're not free thousands of people
suddenly run out or suddenly have extraordinary impulsive reactions. They should never be pre-scribed except for the most severe clinical need.
Yet, unaware ill-informed, insensative "physicians" prescribe them like candy.

[rugby5053]

Tis is in deed a very disturbing suject for those that have lost someone due to suicide. It is also disturbing to those that are on medications that help them to lead normal lives.
I myself am on medications that help me. It took years before there was a doctor that had enough courage to help me. My heart goes out to those family,s that have lost love ones. I was hurt 20 years ago, and lost everything I had worked for. My house my job, my family, and eventually to the streets. It was not until a doctor helped me. I now have a life, a job, a wonderful mate that helps me to keep going. There is a life with the help of medications. I am living proof of that, as I also attempted suicide. I am a survivor.
Thank you,
Rod

[kjgal]

This is such a touchy subject. One drug may work for one but not for others. It took my doctors years to find the right one for me, but thank God, they found the right one. I could barely leave my house 10 years ago. Now I own a home, hold down a fulltime job, and I'm a mother to a beautiful 2 year old. Had it not been for Effexor, I know I would not have gotten this far!

[jstsim]

recently losing a 40 yr old sis-in-law by suicide who was on prescription drugs and being raised by an aunt who did the presciption pushing psychiatrist for life and never seemed to 'even out' mentally but constantly tried committing suicide IMO it is time the FDA quit pushing this whole line of drugs when they obviously DO NOT WORK as they expect them to. Or maybe they do and its just another government form of population control?

funny how the FDA will just put a new warning on the label and say its up to the consumer to decide if they want to take the risk or not. But when it comes to pot , the FDA and gov. has to decide for us. I guess if there was a way to control the money flow of pot and large corporations could profit from it, then there would just be warning labels on it as well.

[cathaleen]

I have met some people who take prozac - the mood swings are incredible = you can tell immediately if someone didn't take their pills. They are very dangerous and young adults should not take these. There should be alternatives for them.

[randalds]

True words alphaa10. The pharmaceutical industry has influenced the FDA for far too long and, even as a dyed in the wool democrat, this is one of those issues where both parties are both equally to blame for taking their money and passing complimentary laws. Personally I'm also in favor of taking ads for prescription medicines back off TV too. Easily influenced people see these ads and rush out to their doctor demanding pills for a condition they been talked into thinking they have and too many doctors go along to shut the patient up and in many cases because of kickbacks from the drug companies. One of the main reasons (if not the main one) our healthcare costs are soaring is that that cost increase is going right into the bank accounts of the big drug companies. The time to bring them down is way overdue.