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Metadate
Injured by Metadate?
Black Box Warning RecommendedOn February 9, 2006, an FDA panel voted to recommend a black box warning for Metadate and other drugs prescribed to treat attention deficit hyperactivity disorder (ADHD or ADD). The Food and Drug Administration scientific committee voted 8-7 to add a black box warning, the agency's strongest, to the labels of five drugs in the class including Metadate, Methylin, Ritalin, Concerta and Adderall.
Deaths Reported to the FDA
The FDA had requested a review by the panel to evaluate ways of studying the ADHD drugs because of its data suggesting a link between the drugs and the risk of sudden death and serious cardiovascular problems including heart attacks, stroke, hypertension, palpitations and arrhythmia. The agency reported 25 deaths between 1999 and 2003 which may be related to the ADHD drugs included in the warning. Nineteen of the 25 deaths were children. There were 54 cases of serious cardiovascular problems reported in children and adults.
About Metadate
Metadate CD is a reformulation of Ritalin for extended delivery over several hours. It comes in 10 and 20 mg tablets and delivers a small, steady dose throughout the day. The active ingredient, methylphenidate, is reported to have serious cardiovascular side effects including cardiac arrhythmia, tachycardia, chest pain and hypertension. Reported psychiatric side effects of methylphenidate include suicidal thoughts, aggression, psychotic behavior and hallucinations.
Legal Help for Metadate Victims
If you or a loved one took Metadate and experienced cardiovascular side effects, sudden death, or psychiatric side effects, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney.
MetadateRSS Feed
ADHD drugmakers must tell of risks
Feb 23, 2007 | SOUTH FLORIDA SUN-SENTINEL
Federal officials told the makers of Ritalin, Adderall, Strattera and all other drugs for treatment of attention deficit hyperactivity disorder, or ADHD, on Wednesday to come up with new pamphlets to explain the potential risks of the drugs to patients and parents. The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and...
Government wants further ADHD drug warnings
Feb 22, 2007 | Baltimore Sun
The makers of Ritalin, Adderall, Strattera and other drugs treating attention-deficit hyperactivity disorder were advised by the government Wednesday to give patients and their parents an additional warning that those medicines could cause serious psychiatric and heart problems, including sudden death. Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart...
ADHD drug makers to warn of side effects
Feb 21, 2007 | AP
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. ...
Drug makers to add warnings to ADHD pills
Feb 21, 2007 | AP
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. ...
ADHD Drugs to Get New Warnings
Feb 21, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) announced today that it is ordering all manufacturers of attention deficit hyperactivity disorder (ADHD) medication to develop Patient Medication Guides to warn patients of potentially serious side effects. The most significant warnings will be related to adverse psychiatric symptoms and to cardiovascular risks. “Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,”...
Metadate
Quick Facts
Metadate Reference Guide
Generic Name
Methylphenidate hcl
Date Approved
October 20, 1999
Manufacturer
Medeva Pharmaceuticals
Status
2/9/06 Black box warning
Approved Uses
ADHD
ADD
Serious Side Effects
Sudden death
Heart attacks
Stroke
Hypertension
Palpitations
Arrhythmia
Methylphenidate hcl
Date Approved
October 20, 1999
Manufacturer
Medeva Pharmaceuticals
Status
2/9/06 Black box warning
Approved Uses
ADHD
ADD
Serious Side Effects
Sudden death
Heart attacks
Stroke
Hypertension
Palpitations
Arrhythmia
Related Topics
Adderall
Concerta
Cylert
Methylin
Ritalin
Strattera
Heart Attack
Stroke
Defective Drugs
Diseases
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