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FDA to Decline Adding Heart Risk Warning on ADHD Drug Labels

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FDA to Decline Adding Heart Risk Warning on ADHD Drug LabelsApril 08, 2011, 03:04 pm

On April 8, the Food and Drug Administration (FDA) announced that attention deficit hyperactivity disorder (ADHD) medications such as Adderall and Ritalin will not be required to include heart risk warnings on drug labels.

"At this time, FDA is not recommending any changes to the drug labels and/or the use of these medications," said the agency in a press release. "FDA will update the public after the results of the final analyses are evaluated."

The American Journal of Psychiatry published an article in 2009 that linked ADHD medications with heart risk. The study examined 564 young adults aged 7 to 19 years old who died suddenly from unknown causes and compared them with the same number of young adults who were killed in car accidents.

Ten people who died from unexplained causes took ADHD medications compared with two who took the drugs and died in motor vehicle accidents, according to the study. The agency said that the data was not conclusive and joined with the Agency for Healthcare Research and Quality to examine the health information of more than 500,000 people taking ADHD medications.

The agency is also reviewing information from more than 1 million people who do not take ADHD drugs and medical chart data from hundreds of different hospitals. The FDA has not made a formal decision about the label warning and is currently reviewing preliminary results from the study that the agency commissioned.

Currently, ADHD medications carry black box warnings indicating an increased risk of dependence and potential withdrawal symptoms such as depression.

According to the Centers for Disease Control and Prevention, approximately 5.4 million children aged 4 to 17 years old have been diagnosed with ADHD in the U.S.

Additional information about drugs and drug side effects may be found on DrugWatch.com.

FDA to Decline Adding Heart Risk Warning on ADHD Drug Labels

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Parkinson's Disease Medications May Cause Impulse Control Problems

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FDA to Decline Adding Heart Risk Warning on ADHD Drug LabelsApril 08, 2011, 03:04 pm

On April 8, the Food and Drug Administration (FDA) announced that attention deficit hyperactivity disorder (ADHD) medications such as Adderall and Ritalin will not be required to include heart risk warnings on drug labels.

"At this time, FDA is not recommending any changes to the drug labels and/or the use of these medications," said the agency in a press release. "FDA will update the public after the results of the final analyses are evaluated."

The American Journal of Psychiatry published an article in 2009 that linked ADHD medications with heart risk. The study examined 564 young adults aged 7 to 19 years old who died suddenly from unknown causes and compared them with the same number of young adults who were killed in car accidents.

Ten people who died from unexplained causes took ADHD medications compared with two who took the drugs and died in motor vehicle accidents, according to the study. The agency said that the data was not conclusive and joined with the Agency for Healthcare Research and Quality to examine the health information of more than 500,000 people taking ADHD medications.

The agency is also reviewing information from more than 1 million people who do not take ADHD drugs and medical chart data from hundreds of different hospitals. The FDA has not made a formal decision about the label warning and is currently reviewing preliminary results from the study that the agency commissioned.

Currently, ADHD medications carry black box warnings indicating an increased risk of dependence and potential withdrawal symptoms such as depression.

According to the Centers for Disease Control and Prevention, approximately 5.4 million children aged 4 to 17 years old have been diagnosed with ADHD in the U.S.

Additional information about drugs and drug side effects may be found on DrugWatch.com.

FDA to Decline Adding Heart Risk Warning on ADHD Drug Labels

Heartburn Drugs May Not Be Effective in Treating Infants with Acid Reflux, Study Finds

Antidepressants Linked to Increased Heart Attack, Stroke Risk, Study Suggests

& Recalls 34,000 Tylenol Bottles, Citing a Musty Odor

Parkinson's Disease Medications May Cause Impulse Control Problems

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FDA to Decline Adding Heart Risk Warning on ADHD Drug LabelsApril 08, 2011, 03:04 pm

On April 8, the Food and Drug Administration (FDA) announced that attention deficit hyperactivity disorder (ADHD) medications such as Adderall and Ritalin will not be required to include heart risk warnings on drug labels.

"At this time, FDA is not recommending any changes to the drug labels and/or the use of these medications," said the agency in a press release. "FDA will update the public after the results of the final analyses are evaluated."

The American Journal of Psychiatry published an article in 2009 that linked ADHD medications with heart risk. The study examined 564 young adults aged 7 to 19 years old who died suddenly from unknown causes and compared them with the same number of young adults who were killed in car accidents.

Ten people who died from unexplained causes took ADHD medications compared with two who took the drugs and died in motor vehicle accidents, according to the study. The agency said that the data was not conclusive and joined with the Agency for Healthcare Research and Quality to examine the health information of more than 500,000 people taking ADHD medications.

The agency is also reviewing information from more than 1 million people who do not take ADHD drugs and medical chart data from hundreds of different hospitals. The FDA has not made a formal decision about the label warning and is currently reviewing preliminary results from the study that the agency commissioned.

Currently, ADHD medications carry black box warnings indicating an increased risk of dependence and potential withdrawal symptoms such as depression.

According to the Centers for Disease Control and Prevention, approximately 5.4 million children aged 4 to 17 years old have been diagnosed with ADHD in the U.S.

Additional information about drugs and drug side effects may be found on DrugWatch.com.

FDA to Decline Adding Heart Risk Warning on ADHD Drug Labels

Heartburn Drugs May Not Be Effective in Treating Infants with Acid Reflux, Study Finds

Antidepressants Linked to Increased Heart Attack, Stroke Risk, Study Suggests

& Recalls 34,000 Tylenol Bottles, Citing a Musty Odor

Parkinson's Disease Medications May Cause Impulse Control Problems

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FDA to Decline Adding Heart Risk Warning on ADHD Drug LabelsApril 08, 2011, 03:04 pm

On April 8, the Food and Drug Administration (FDA) announced that attention deficit hyperactivity disorder (ADHD) medications such as Adderall and Ritalin will not be required to include heart risk warnings on drug labels.

"At this time, FDA is not recommending any changes to the drug labels and/or the use of these medications," said the agency in a press release. "FDA will update the public after the results of the final analyses are evaluated."

The American Journal of Psychiatry published an article in 2009 that linked ADHD medications with heart risk. The study examined 564 young adults aged 7 to 19 years old who died suddenly from unknown causes and compared them with the same number of young adults who were killed in car accidents.

Ten people who died from unexplained causes took ADHD medications compared with two who took the drugs and died in motor vehicle accidents, according to the study. The agency said that the data was not conclusive and joined with the Agency for Healthcare Research and Quality to examine the health information of more than 500,000 people taking ADHD medications.

The agency is also reviewing information from more than 1 million people who do not take ADHD drugs and medical chart data from hundreds of different hospitals. The FDA has not made a formal decision about the label warning and is currently reviewing preliminary results from the study that the agency commissioned.

Currently, ADHD medications carry black box warnings indicating an increased risk of dependence and potential withdrawal symptoms such as depression.

According to the Centers for Disease Control and Prevention, approximately 5.4 million children aged 4 to 17 years old have been diagnosed with ADHD in the U.S.

Additional information about drugs and drug side effects may be found on DrugWatch.com.

FDA to Decline Adding Heart Risk Warning on ADHD Drug Labels

Heartburn Drugs May Not Be Effective in Treating Infants with Acid Reflux, Study Finds

Antidepressants Linked to Increased Heart Attack, Stroke Risk, Study Suggests

& Recalls 34,000 Tylenol Bottles, Citing a Musty Odor

Parkinson's Disease Medications May Cause Impulse Control Problems

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