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Author Topic: New FDA required warning for side effects for ADHD drugs  (Read 3433 times)
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nonesuche
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« on: February 21, 2007, 07:27:42 PM »

Updated:2007-02-21 15:33:06

New Warning for Attention Deficit Drugs
AP

WASHINGTON (Feb. 21) - Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday's announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.
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justinsmama
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« Reply #1 on: February 21, 2007, 07:47:40 PM »

Thanx for posting this. Justin has been on Ritalin for several years. While it is effective in managing the ADHD symptoms, I worry about side effects. His psychiatrist checks his vitals with each visit, as well as height and weight. I've wondered for a long time if the cardiovascular effects exacerbate his anxiety disorder.
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Seamonkey
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« Reply #2 on: February 21, 2007, 07:59:47 PM »

Hello nonesuche,
  Wonderful article for parents and anyone else taking a adhd medication.
My son was diagnosed with adhd a few years ago. I was told of which medicines we could "experiment" on him with to see which works best. I told my doctor to wait until I had time to research them. After reading about any Ritilan based ones I quickly no no to those. It can change personalities. We had him on adderall for awhile and I didn't like the effects, he became defiant where he had never been before, you could tell when it would wear off, a quick drop in all energy and even mood. There was a few months there I had him on nothing, then I called the company that makes strattera, which was a slow released medicine, meaning only one in the morning and the side effects were proven not as severe. So i asked my doctor if we could try that. Given my son's level of adhd he is on the lowest dosage for his size. We get him physically checked every three months religiously to make sure there is no bad effects. He has now been on it for three years and I can't tell when he isn't on it except his school work is better. This medicine causes no noticble personality changes. On weekends, vacations, and summer I do not have him on it and his doctor feels he may outgrow it as many do, at least the children who have it, some do outgrow it.

 The main thing I would like for parents to know is when and if your child is diagnoised with adhd, do your research, you do NOT have to automatically agree to have your child on a medicine just because your doctor says he should, do your research to see which medicine would be BEST for YOUR child. And by all means make sure you get them physically checked every three months and always take note of any personality changes. My son is almost 12 now, sometimes I need to remind myself what a touchy little 12 year old male can be like and not jump to conclusions it is the medicine lol. But a parent can tell "normal" behavior from not normal behavior.

 again, wonderful article for people to need to know, thank you for sharing it.
 SeaMonkey ( who remembers when there was no adhd , just kids the teachers would call lazy anda  trip to the principal's office magically fixed it and cured them lol)
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nonesuche
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« Reply #3 on: February 21, 2007, 08:22:45 PM »

Welcome Seamonkey!

my son is nearly 20 now but he was diagnosed with moderate ADD but no hyperactivity in second grade. We tried ritalin for one month until his anxiety attacks grew so bad he locked himself in the bathroom for 3 hours. Next we did no meds for six years but he did have weekly tutorials and treatment with a learning specialist. When he went into puberty the ADD grew more intense, so we tried Strattera. Son had no appetite and severe headaches on a very low dose, so he was offered a scholarship to a strong private school and we accepted it. It meant he left me earlier than I wanted him to, but this school did a great job of providing him structure and learning support and once again the ADD lessened.

Now he's a B student in college, I feel all you are going through but I also knew son had a slight heart murmur as does my brother. I just couldn't reconcile the risk of these drugs and their side effects then, and without knowing the more extreme side effects I"m just so glad my intuition led me to seek learning strategies instead.

each parent has to do what is right for their child, what's right for mine just wasn't medication but I do hope strattera continues to work for your son. Justins, I hate to post this for I know what a caring and dedicated parent you are, but ritalin terrifies me the most of all of these.  Confused
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justinsmama
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« Reply #4 on: February 21, 2007, 09:12:15 PM »

I know, nonesy. The ADHD is so bad that Justin is literally a danger to himself and others without the Ritalin. Otherwise, he leaps into action with any and every impulse.  Crying or Very sad
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