(This entry is #5 in a series of posts regarding medicating children for behaviors)
My intention today was to write about the antidepressant medications, but I needed to address an FDA communication which you may have read about since my last post.
My intention today was to write about the antidepressant medications, but I needed to address an FDA communication which you may have read about since my last post.
On June 15, 2009 the FDA issued Communication about an Ongoing Safety Review of Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Essentially, this study compared the sudden deaths of U. S. children by two means: 564 children who died suddenly in motor vehicle accidents, and 564 children who died suddenly with no known health problems.
The conclusion of the study:
1. Out of 564 healthy children who died suddenly with no known health problems, 10 were reported to be taking a stimulant medication at the time of death.
2. Out of 564 healthy children who died suddenly in motor vehicle accidents, 2 were reported to be taking a stimulant medication at the time of death.
3. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.
While there are limitations to this study, including a significant lag time between the deaths and the data collection, the FDA reports that it is continuing to study the risks of stimulant medications used to treat children with ADD/ADHD. Data collection for a new study should be complete by the end of 2009.
The FDA recommendation issued on June 15, 2009:
Follow all the current prescribing information for use of these medications, including:
1. Take a medical history for cardiovascular disease in the child and his or her family.
2. Perform a physical exam with special focus on the cardiovascular system (including examination for the signs of Marfan syndrome).
3. Consider obtaining further tests such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease.
4. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
The FDA contends that this study does not mean that they are advising health care providers to discontinue prescribing these medications. However, the FDA does state that they are considering whether this information warrants further regulatory action.
Please note the FDA is continuing to study the stimulant medications . This is quite frightening alone, but review my earlier posts and my observation that stimulants and long-acting stimulants are often prescribed together, perhaps along with blood-pressure medications, antipsychotics, and antidepressants. It certainly bears a closer look in weighing the benefits versus the risks of these medications. Please take some time to do so.
The conclusion of the study:
1. Out of 564 healthy children who died suddenly with no known health problems, 10 were reported to be taking a stimulant medication at the time of death.
2. Out of 564 healthy children who died suddenly in motor vehicle accidents, 2 were reported to be taking a stimulant medication at the time of death.
3. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.
While there are limitations to this study, including a significant lag time between the deaths and the data collection, the FDA reports that it is continuing to study the risks of stimulant medications used to treat children with ADD/ADHD. Data collection for a new study should be complete by the end of 2009.
The FDA recommendation issued on June 15, 2009:
Follow all the current prescribing information for use of these medications, including:
1. Take a medical history for cardiovascular disease in the child and his or her family.
2. Perform a physical exam with special focus on the cardiovascular system (including examination for the signs of Marfan syndrome).
3. Consider obtaining further tests such as a screening electrocardiogram and echocardiogram if the history or examination suggests underlying risk for or the presence of heart disease.
4. Any child who develops cardiovascular symptoms (such as chest pain, shortness of breath or fainting) during stimulant medication treatment should immediately be seen by a doctor.
The FDA contends that this study does not mean that they are advising health care providers to discontinue prescribing these medications. However, the FDA does state that they are considering whether this information warrants further regulatory action.
Please note the FDA is continuing to study the stimulant medications . This is quite frightening alone, but review my earlier posts and my observation that stimulants and long-acting stimulants are often prescribed together, perhaps along with blood-pressure medications, antipsychotics, and antidepressants. It certainly bears a closer look in weighing the benefits versus the risks of these medications. Please take some time to do so.
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2 comments:
Lori: thanks for your informative and sharp comment on medicating children. I recently blogged about similar problems - like how in all of 49 trials of stimulant medication psychosis or mania was seen, as opposed to not once in the placebo group.
The medications are very strong and need to be prescribed carefully.
David,
Thank you for your kind comments. I did read your blog and was very impressed with your information on the same subject.
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