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Concerta Side Effects Lawsuits | Side Effects: Cardiovascular Problems, Hypertension, Arrhythmia's, Chest Pain, Tachycardia

Concerta Side Effects Linked To Cardiovascular Lawsuits

Concerta | Lawsuits, Lawyers | Side Effects: Cardiovascular Problems, Hypertension, Arrhythmia's, Chest Pain, Tachycardia

The FDA announced on June 29, 2005 that they are adding a new warning concerning psychiatric side effects to the label of Concerta. Concerta is used to treat attention deficit hyperactivity disorder, or ADHD. The FDA approved Concerta manufactured by Johnson and Johnson on August 1, 2000.

Reported psychiatric side effects of Concerta include suicidal thoughts, aggression, psychotic behavior and hallucinations. Concerta's label already includes warnings about psychiatric side effects; the warnings may downplay the seriousness of the side effects.

The current label suggests that Concerta may exacerbate an existing psychiatric condition. However, of the 36 reports of psychiatric side effects among Concerta users, only 6 reported a history of a psychiatric condition. Additionally, the FDA has received reports of cardiovascular problems in Concerta users including hypertension, arrhythmia's, chest pain, and tachycardia.

In 2004, 7.8 million prescriptions for Concerta were written in the United States. In addition to Concerta and Ritalin, the FDA is also investigating the ADHD drugs Adderall and Strattera.

On January 3, 2006, the Food and Drug Administration asked its standing committee of risk-management advisers to review reports of heart-related complications in children and adults using attention deficit disorder drugs. U.S. and Canadian regulators have been looking in the past few years at the probable heart risk of attention-deficit drugs, which are stimulants used to improve concentration.

The three main ADHD drugs that will be reviewed at the February 9, 2006 FDA meeting include Adderall, Concerta, and Strattera

On February 9, 2006, Federal science advisers voted narrowly on proposing the most serious type of warning labels for Concerta, Adderall, Ritalin and all other ADHD drugs. The Food and Drug Administration (FDA) Committee voted 8-7, recommending the adding of black box safety warnings to ADHD drugs. Doctors prescribe ADHD drugs to approximately 2 million children and 1 million adults a month.

The FDA's data suggested a link between ADHD drugs and an increased risk of sudden death and serious cardiovascular problems, including heart attacks. Dr. Steve Nissen told his colleagues they should push for the black box warning on the ADHD drugs' packages. A federal health official said Thursday that there was a strong possibility the drugs may be linked to the deaths of 25 people.

The deaths took place between 1999 and 2003, based upon a FDA report. Nineteen of them involved children. The report also detailed 54 cases of severe cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia, in adults and children being treated with ADHD drugs.

Sales of Concerta, Adderall, Ritalin and other ADHD drugs increased to $3.1 billion in 2004, from $759 million in 2000, according to IMS Health, a pharmaceutical information and consulting firm.

Legal Help For Victims Affected By Concerta

If you or a loved one took Concerta and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


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ADHD Drug Study Finds Heart Death Risks for Kids, But FDA Says Recommendations Won't Change

Jun 16, 2009 | Parker Waichman LLP
While a new study has found that stimulant medications used to treat attention-deficit hyperactivity disorder (ADHD) may increase the risk of sudden cardiac death in children, the Food & Drug Administration (FDA) is not changing its recommendations on the way such drugs are prescribed.  According to a posting on its website, the agency is asserting that the study had "limitations" that makes it difficult to draw conclusions about the drugs' risks.Labeling for drugs like...

American Children Take the Most Psychotropic Drugs

Sep 26, 2008 | Parker Waichman LLP
A new study reports that American children are about three times likelier to be prescribed psychotropic medications than children in Europe.  The study states that the differences may be attributable to regulatory practices and cultural beliefs about the role of medication in emotional and behavioral problems.Julie Zito led the team comprised of researchers from the U.S., Germany, and the Netherlands.  The group investigated prescription levels in the three countries.  Zito...

Screen for Kids for Heart Problems Before Prescribing ADHD Drugs, Heart Group Says

Apr 22, 2008 | Parker Waichman LLP
Children with Attention Deficit Hyperactivity Disorder (ADHD) should be screened for heart problems before they are prescribed stimulant drugs like Ritalin, the American Heart Association has warned. About 2.5 million American children and 1.5 million adults take stimulants such as Ritalin, Adderall and Concerta to control the symptoms of ADHD.  Such drugs are known to increase heart rates, a side effect that can be dangerous - and even deadly - if a patient has an undetected heart...

ADHD drugmakers must tell of risks

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...

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