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Attention Deficit Hyperactivity Disorder

Unearthing the Side Effects of Adderall

05/11/2000

Question:

Attached you will find a copy of a web page describing Adderall in a way that actually spelled out the "real" side effects and disorders triggered by Adderall. Upon further research, I found that Adderall was actually a drug used to treat obesity and then changed over to treat ADD.

Why are physcians not telling parents of these adverse side effects? Why are the parents being mislead and the doctors not staying up to date on the actualities of this medication?

My daughter is eight years old and has lost over 30lbs this school year due to her ADD treatment with Adderall. Her little body now looks like a skeleton and she is being treated for anorexia like symptoms to try to gain weight. Every time we went to her physician we were told she is just being active and that the side effects from Adderall were just appetite supression, nothing more!

When will doctors be able to be fully informed before a medication is administered? Why isn`t there a law to force doctors and pharmacies to inform patients of all the side effects of a medication?

Return to Drug Listings Newly Approved Drug Therapies

Drug Name: Adderall (mixed salts of a single-entity amphetamine)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Richwood Pharmaceutical Company Approval Status: Supplemental NDA Approved February 1996 Treatment for: attention-deficit/hyperactivity disorder (ADHD)

General Information Adderall has been indicated for use in children 3 years of age and older with ADHD as an integral part of a total treatment program which typically includes psychological, educational, and social measures. Adderall may improve attention span, decrease distractibility, and increase the ability to follow directions and finish tasks. The therapy may also improve the patient`s ability to think before acting (decrease impulsivity), decrease hyperactivity and improve legibility of handwriting. In addition, aggression may decrease in youngsters with ADHD.

Adderall is available in 10 mg and 20 mg double-scored tablets.

Side Effects Adderall is generally well tolerated with few adverse reactions reported. The most frequently reported adverse reactions include anorexia, insomnia, stomach pain, headache, irritability, and weight loss. As with most psychostimulants indicated for ADHD, the possibility of growth suppression and the potential for precipitating motor tics and Tourette Syndrome exists with Adderall treatment, and in rare cases exacerbations of psychosis have been reported. Since psychostimulants have a high potential for abuse, Adderall should only be prescribed as part of an overall treatment program for ADHD with close physician supervision.

Additional Information Adderall had previously been approved and marketed by another company under the name of Obetrol, indicated for exogenous obesity and ADHD. Richwood acquired the company, including the formulation and manufacturing rights to Obetrol, and renamed the product Adderall in 1994.

Last updated on January 13, 2000

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Answer:

You raise some very important concerns that everyone using stimulants, or with children using stimulants, should be aware of. Of most importance, a thirty-pound weight loss in an eight year old is very concerning and should be brought to the attention of the physician, soon. Since I do not know your daughter or many specifics about her case, I urge you to speak directly with health professionals who know her for any specific answers.

Knowing about medication side effects is, obviously, very important; particularly any that can be harmful or that may continue after a medication is discontinued. The ADD specialists I work with locally and meet nationally seem to be very responsive to those concerns. As a specialist, I often do evaluations on children or adults who had been put on medications prior to coming to The Affinity Center. Once in a while I do come across patients who are not aware of some important side effect. Usually, it is not weight loss. The most common one I hear about in that situation is "flat affect", also referred to as "too quiet" or "zombie-like". Notably, that side effect is not in many of the handouts I have seen on stimulants, including the one you included from an unidentified site on the Web.

To understand why some of these things happen, it helps to understand where the original “official” list of side effects comes from. When the Food and Drug Administration (FDA) allows a drug to be marketed, they guide what side effects need to be mentioned on the brochure that accompanies the medication. They also guide how to phrase things. Most commonly, they base their initial guidelines on the three to six months of final-phase studies done with patients trying out the medication at a specific dose and dose frequency. Since many new side effects, both negative and positive, are not noted until after those studies, they may not be listed or emphasized in the most up-to-date manner. Whenever a potentially crucial side effect is discovered, like when one specific diet pill was found to be associated with heart problems two years ago, a warning letter is sent out to every doctor the FDA can identify in the U.S. Less concerning side effects may not make official written changes for years and good side effects (such as the discovery that a specific type of heart medication also is a great kidney medication because it protects against diabetic kidney disease) may not become “official” indications for years as well.

Some of the side effects identified in your email (anorexia, insomnia, stomach pain, headache, irritability, and weight loss) are those the pharmaceutical company was told to put in. The FDA chooses to have side effects mentioned for many reasons. Most often it is because they are the more common ones (which is the case for those I mentioned), because they have been associated with such severe problems that they are worth noting even if there is only a one in a 100,000 chance, or because they have happened in at least a few verified cases. In some lists, it is hard to tell which category a side effect fits into, or if it is an even different category. All of the common side effects mentioned in the above paragraph resolve within a few weeks in the great majority of patients. If they significantly interfere with normal functioning or if they do not resolve after 6-8 weeks on a stable medication dose, they need to be re-evaluated. Most often, that reevaluation would lead to a dose change, a dose timing change, or new medication. Some of the side effects are actually GREATLY questioned in the current medical studies. For instance, the statement you refer to that reads “As with all stimulants indicated for ADHD, the possibility of growth suppression and the potential for precipitating motor tics and Tourette Syndrome exists with Adderall treatment, and in rare cases exacerbations of psychosis have been reported.” More recent studies strongly support the fact that, although stimulants may initially slow growth in a few children, they catch up to their peers within two years. In addition, another statement that you included would be considered misleading by the great majority of health professionals working with many people with ADD.

And, last but certainly not least, in response to the very important question that you raise, “When will doctors be able to be fully informed before a medication is administered?” Many, many new drugs come out every month. The great majority of physicians and pharmacists try very hard to keep up with it all. Major pharmacies hand out information pamphlets on drugs with each prescription (although they tend to include every little and big and short term and long term side effect under one category). Pharmaceutical Representatives visit physician’s offices regularly with some information but it tends to be what the pharmaceutical company wants to emphasize which may or may not be what is best. However, with so much new scientific information out in this world every day, I urge everyone to become knowledgeable consumers and do exactly what you have done, do some of your own research, although keep in mind that just because it is on the Net does not mean it is true.

That is why sites like NETWELLNESS, with expert insights that are without any financial interest in the drugs we talk about, can be so helpful. Thanks for your questions and concerns.

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Response by:

Susan Louisa Montauk, MD
Formerly Professor of Family Medicine
University of Cincinnati