October 26

AMA Serves Pharma Marketing Priority/ FDA To Add Warnings on ADHD drugs–Concerta, Ritalin, Strattera, Adderall

AMA Serves Pharma Marketing Priority/ FDA To Add Warnings on ADHD drugs–Concerta, Ritalin, Strattera, Adderall

Wed, 29 Jun 2005

The FDA is finally taking note of the fact that many drugs prescribed for the treatment of psychiatric problems are CAUSING serious psychiatric and cardiovascular problems in children and adolescents ! By contrast, the American Medical Association has demonstrated its unswerving allegiance to the drug industry despite the harm caused.

Rather than showing concern for children whose lives are at a twofold increased risk of suicide when prescribed an antidpressant, the AMA has issued a report declaring “Antidepressants Are Safe for Adolescents.” This, despite the failure of antidepressant drug manufacturers to demonstrate scientifically a drug benefit for children, while a body of documented evidence shows that these drugs have caused children harm.

For example, a 2003 Harvard study shows that 74% of children prescribed an SSRI antidepressant suffered adverse effects. Furthermore, thousands of adverse drug reports have been filed with the FDA–representing 10% of actual adverse drug effects involving antidepressants. Two FDA advisory committees recommended black box warnings about these drugs’ propensity to induce violent and suicidal behavior in children.

Yet, despite physicians’ sworn obligation to “do no harm” when prescribing a treatment, the AMA’s Council on Scientific Affairs issued a scientifically unsupportable pronouncement that will, no doubt, harm children. By its action, the AMA has demonstrated its allegiance toward its financial benefactors–the drug industry–even recommending–what its members know to be treatments that undermine children’s best interest. The documented evidence shows that SSRI antidepressants increase rather than decrease the suicide risk for adolescents compared to those taking a sugar pill–and the drugs stunt children’s growth, and affect liver and cardiac function.

When publicly confronted with the overwhelming documented evidence, the FDA issued a requirement that manufacturers of antidepressants must include black box warnings. Those warnings have affected physicians’ prescribing patterns–and this has alarmed the AMA.

The FDA now acknowledges that another class of widely prescribed psychotropic drugs–Amphetamines / methylphenidate–pose serious risks of harm. The drugs have been shown to be indiscriminately prescribed for children whose behavior (sometimes their non-conformist attitude) have been “diagnosed” as having ADHD. Dr. Gretchen LeFever and Dr. Julie Zito have documented the abusive prescribing of psychotropic drugs for children under Medicaid / Medicare coverage. See: https://ahrp.org/infomail/05/04/10.php and https://ahrp.org/infomail/05/05/22a.php

The FDA now acknowledges that these drugs have induced severe psychiatric events “such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.”

The drugs in the category include Johnson & Johnson’s Concerta, Novartis Ritalin, which is also available as a generic.

Due to overwhelming evidence of serious, drug-related harm–and public criticism of the FDA’s role in keeping these effects concealed, the Wall Street Journal reports that the agency plans to change the labels for this class of psychotropic drugs after deliberation by an advisory committee meeting today and tomorrow.

Among the adverse drug effects that have not, until now, been disclosed to physicians or parents, are the following psychiatric effects: — Visual hallucinations, suicidal ideation, psychotic behavior, aggression or violent behavior.

Additionally, the Journal reports, the FDA also plans to explore possible cardiovascular concerns with ADHD drugs. The FDA had received numerous adverse reports involving Concerta including: — Hypertension, chest pain, arrhythmias and tachycardia, or rapid heartbeat

“An FDA spokeswoman declined to discuss the number of psychiatric adverse event reports it has received related to Concerta and similar drugs, saying the data would be presented to the pediatric panel on Thursday….In addition we believe it is critical to examine the other stimulant products approved for ADHD…to determine if they too are associated with these adverse events,” the FDA said in its statement.”

The agency also said it would look at atomoxetine, an antidepressant manufactured by Eli Lilly and sold under the brand name Strattera, which is prescribed for ADHD.

Of note, psychotropic drugs cause sexual dysfunction, which produce a plethora of adverse consequences for adolescents. The FDA has yet to acknowledge or address these adverse effects. Cynics have suggested that drugs which cause sexual dysfunction may be industry’s way to ensure a steady market for sexual enhancement drugs.


AMA Council on Scientific Affairs Says Antidepressants Are Safe for Adolescents

By M. Mary Conroy

CHICAGO (Reuters Health) Jun 20 – A new report from the American Medical Association’s Council on Scientific Affairs (CSA) suggests that anti-depressants, including selective serotonin reuptake inhibitors such as fluoxetine (Prozac), are appropriate therapies for the treatment of depression in teenagers.

Moreover, the CSA reports states that even off-label usage is justified if physicians use prudent clinical judgment.

The CSA report, which was discussed at an AMA reference committee hearing Sunday, was immediately endorsed by delegates representing the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics.

“We believe this is a fair and balanced report,” said Dr. Melvyn Sterling, clinical professor of medicine at the University of California, Irvine, and chairman of the council.

Dr. Sterling said the council report recommends that SSRIs remain available for use in both children and adolescents and states that current clinical evidence “indicates that fluoxetine is an effective SSRI in children and adolescents with major depressive disorder.”

Antidepressants, especially SSRIs, have come under increased scrutiny by the Food and Drug Administration and Congress amid reports of increased suicides among teenager using the drugs.

In additional testimony before the same reference committee representatives from the American Institute of Ultrasound in Medicine argued against the use of ultrasound to provide in-utero “keepsake” scans of babies.

Dr. Marilyn Laughead of Scottsdale, Arizona, an AMA delegate representing the ultrasound group, said that while there is no confirmed biological effect of ultrasound on fetuses, “there may be some effect identified in the future. For that reason ultrasound should be used only for medically indicated purposes.”

The AMA will begin voting on these issues later this week.



Antidepressant warnings spur usage debate
Thursday, June 23, 2005
Star-Ledger Staff

The American Medical Association fears tough warnings on antidepressants may be steering doctors and parents away from prescribing the drugs to children who need them.

The AMA, at its annual meeting in Chicago this week, voted to urge the U.S. Food and Drug Administration to evaluate whether the labels have changed the way doctors and young patients use the drugs.

“I’m concerned that some people may be confused and frightened and that some parents may become reluctant to get help for their children who may have depression or other psychiatric disorders,” David Fassler, a delegate to the AMA from the American Academy of Child and Adolescent Psychiatry, said.

The FDA last year told drug makers to place so-called black- box warnings, the FDA’s highest alert, on antidepressants such as Prozac, Paxil, Effexor and Zoloft, saying a “causal role” between the drugs and suicide in young people had been established. Early this year, the FDA changed — critics say diluted — its warning to say the drugs “increased the risk of suicidal thinking and behavior” in young people.

The FDA warnings followed a report by a government panel that determined the medicines were linked to suicide in young people.

The number of prescriptions written for children fell 10 percent last year. Critics of the drug applauded the decline and criticize the AMA for sending mixed messages to both doctors and parents.

“The black box is doing exactly what it should do. It’s making physicians and families and moms and dads think twice,” said Laurie Yorke of Clark, whose son attempted suicide while on antidepressants. “Parents are not stupid. They are doing their own research. They’ve seen ‘Prime Time Live’ and all these shows and talked to parents like me,” she said. She added no one should suddenly stop taking antidepressants.

Fassler said the AMA vote followed an AMA report he said should reassure physicians and parents about antidepressants in children.

“The medication can be a useful and important component of treatment for children and adolescents for depression,” he said. “It’s most effective when part of a comprehensive treatment plan.”

The debate has been raging for several years, as stories of out-of- character violence and suicide attempts by children on the drug prompted authorities to study the matter.

An FDA spokeswoman, Susan Cruzan, said the agency will continue to monitor the number of prescriptions written for the antidepressants because they modify the levels of the brain chemical serotonin. She said Thomas Laughren, an FDA scientist, responded to inquires about the AMA vote by reminding doctors the black-box warning doesn’t mean doctors can’t prescribe the drug to children, but rather they must balance risk against need, and patient monitoring is important.

In the trenches of child psychiatry, some doctors said their peers are using the drugs with extreme caution — if at all.

“I know some colleagues who have completely stopped giving antidepressants (to children), and I have worked with parents who refuse to allow their children on antidepressants,” Ellen Platt, a child and adolescent psychiatrist in Cedar Grove, said. “There is more caution in the experienced psychiatric community,” she said.

Platt said she has always been careful with the drug and prescribed it only sparingly and with close monitoring of patients.

“Obviously, it depends on the case. I was always cautious and had extensive conversations with parents,” she said. “My practice has not changed a whole lot.”

(c) 2005 The Star Ledger (c) 2005 NJ.com All Rights Reserved.


FDA Raises Concerns About ADHD Drugs; New Labels for Concerta, Others Will Describe Possible Side Effects, Including Suicidal Thoughts
Anna Wilde Mathews and Leila Abboud.
Wall Street Journal (Eastern Edition). New York, N.Y.:Jun 29, 2005. p. D.1

THE FOOD AND DRUG Administration said it plans to add information about possible psychiatric side effects to the labels of a drug category that includes Concerta and Ritalin, which are widely used treatments for attention deficit hyperactivity disorder — and it will investigate other ADHD medicines for similar problems.

In a document posted yesterday on its Web site, the FDA said it has received reports of patients experiencing psychiatric events such as hallucinations, suicidal thoughts and psychotic behavior as well as aggression and violent actions while using forms of methylphenidate, which is the generic name for Ritalin. Concerta, made by Johnson & Johnson, is a long-acting form of methylphenidate. Ritalin, made by Novartis AG, is widely prescribed as a generic.

The FDA said it “intends to make labeling changes describing these events,” and asked its pediatric advisory committee for comments. But the agency’s approach likely signals that it doesn’t see the label change as an urgent safety issue. The statement doesn’t say the FDA has confirmed any causal link between such reports and the drugs, or that the descriptions will necessarily go in the warnings section of the drugs’ labels.

Reports to FDA’s adverse-event system, which appear to be the basis for the agency’s planned label change, are of limited value in detecting and confirming side effects. Only drug companies are required to file them, though doctors and members of the public may do so voluntarily. It is difficult to figure out the true rate of a problem based on such anecdotal filings, or whether a problem might have naturally occurred without the drug.

Still, the agency and companies often place such reports in labeling even when a link isn’t proven. And the FDA is increasingly seeking to flag early signs of potential safety concerns, as part of a move toward greater openness about drug risks.

An FDA spokeswoman said the agency brought the ADHD issue to the advisory committee as part of its regular required reviews of drugs that have been studied for children. She added that the FDA doesn’t plan to change the labeling on the methylphenidate drugs until it has evaluated competing products such as amphetamines — a group that includes Shire Pharmaceuticals Group PLC’s Adderall — and Eli Lilly & Co.’s Strattera, an ADHD treatment that has a different mechanism of action. The FDA statement said it hopes to bring to the committee a review of events associated with these products in early 2006, which would seem to indicate that the label change won’t be until then.

The FDA also said it plans to take further steps to explore possible cardiovascular concerns with ADHD drugs, including potentially doing studies using patient databases or calling for safety trials. The agency said it had received reports of events including hypertension and arrhythmias in users of Concerta. Earlier this year, Canadian regulators suspended sales of the long-acting form of Adderall because of cardiovascular worries.

A label change for Concerta and other methylphenidates will be important, because they are widely used. There were 7.8 million prescriptions dispensed in the U.S. last year for Concerta, and 2.5 million for methylphenidate, according to IMS Health, a health-care information company.

The brief FDA statement — expected to be supplemented today when it posts more information in advance of the committee’s discussion tomorrow — left doctors, parents and patients confused. Several parents said they would wait for more definitive findings before taking any action. Suzanne Beckles, an Oakland, Calif., flight attendant who takes Concerta herself and gives it to her 12-year-old daughter because both have attention-deficit conditions, said she has no plans to halt use of the drug. “I think that my child functions at a higher level with the medication,” she says.

Psychiatrists said that it is difficult to decide how to respond. But several said reports of psychiatric conditions may crop up when ADHD drugs are prescribed incorrectly, meaning given to kids who have other psychiatric conditions like bipolar disorder and depression. For instance, if a child is bipolar but is misdiagnosed with ADHD and given a stimulant such as methylphenidate, it is likely the drug will actually push the child into mania.

Currently, the Concerta label notes that “clinical experience suggests” that in psychotic patients, methylphenidate may “exacerbate symptoms of behavior disturbance and thought disorder.”

A.J. Allen, the medical director of global neuroscience at Eli Lilly, said the Indianapolis company had analyzed all of its clinical trial data on Strattera and psychiatric adverse events, including aggression, hostility and suicidality, for European regulators. The review showed no increased risk of suicide or suicidal thoughts. But Lilly did observe increased frequency of aggression and hostility, although the result was “not statistically significant.” The company added this information to the Strattera label in the U.S. and Europe.

Johnson & Johnson, which markets Concerta, declined to comment ahead of the FDA’s presentation tomorrow. Shire Pharmaceuticals didn’t respond to calls requesting comment on Adderall. A Novartis spokeswoman said the company hadn’t yet reviewed the FDA information and declined to comment.

Zachary Goldfarb and Sara Schaefer Munoz contributed to this article.

Adverse Events

The FDA plans to change the labels for certain ADHD drugs to describe reports of the following psychiatric events: — Visual hallucinations, suicidal ideation, psychotic behavior, aggression or violent behavior.

The agency also plans to explore possible cardiovascular concerns with ADHD drugs, and it had received reports of events in Concerta users including: — Hypertension, chest pain, arrhythmias and tachycardia, or rapid heartbeat

Copyright (c) 2005, Dow Jones & Company Inc.


NY Times
National Briefing
West, Northwest, Midwest, South, New England and Science and Health
Published: June 29, 2005

MEDICAL PROBLEMS WITH ATTENTION DEFICIT DRUG Users of Johnson & Johnson’s Concerta attention-deficit disorder drug have experienced hallucinations, psychotic behavior, suicidal thoughts and heart complications like high blood pressure, federal regulators said. The Food and Drug Administration is considering how to inform doctors and consumers about the complications, which have appeared in users of Concerta and other drugs for attention deficit disorder, the agency said in a statement on its Web site, www.fda.gov/default.htm. (Bloomberg News)

FDA: Concerned With Psychiatric Risks With ADHD Drugs
June 28, 2005
By Jennifer Corbett Dooren

WASHINGTON -(Dow Jones)- The Food and Drug Administration said it intends to make labeling changes for a certain class of drugs used to treat attention deficit hyperactivity disorder over concerns about psychiatric events associated with the drugs.

The FDA said it would make labeling changes to Johnson & Johnson’s (JNJ) Concerta and other methylphenidate products describing psychiatric events “such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior.” The drugs are used to treat ADHD in adults and children. Other drugs in the category include Novartis AG’s (NVS) Ritalin, which is also available as a generic.

The FDA made the statement Tuesday as part of background material posted to its Web site ahead of a pediatric advisory committee meeting Wednesday and Thursday.

An FDA spokeswoman declined to discuss the number of psychiatric adverse event reports it has received related to Concerta and similar drugs, saying the data would be presented to the pediatric panel on Thursday.

A Johnson & Johnson spokeswoman wasn’t immediately available to comment on Concerta. ADHD is a disorder in which people have attention, or inattention, problems that cause impairment in academic, work or social settings. People with ADHD are often hyperactive and impulsive. ADD is a similar disorder without the hyperactive behavior that is often associated with adults more than children.

The panel of outside medical experts will be discussing adverse event reports in children for several drugs including Concerta. The reports are mandated by law for drugs approved specifically for use in children and are discussed before the pediatric panel on a periodic basis.

“In addition we believe it is critical to examine the other stimulant products approved for ADHD…to determine if they too are associated with these adverse events,” the FDA said in its statement. The agency also said it would look at atomoxetine, a nonstimulant product sold under the brand name Strattera by Eli Lilly and Co. (LLY).

The agency said it was currently reviewing adverse event reports for so-called amphetamine products like Shire Pharmaceuticals PLC’s (SHPGY) Adderall as well as for Strattera and hoped to bring the review to the pediatric panel in early 2006.

Meanwhile, the FDA is seeking the panel’s advice on what information it should provide to the public about the ADHD drugs that are widely used in children while it’s collecting information on the number of types of psychiatric events possibly associated with ADHD drugs along with possible cardiovascular risks.

The agency is concerned with possible cardiovascular events in people using the drugs. Earlier this year Health Canada ordered Adderall off the market after reports of sudden death in 20 patients, including 12 reports of stroke.

Last year the FDA required Shire to update Adderall’s label in the U.S. to warn that it should not be used in children or adults with structural cardiac abnormalities.

The FDA said it’s too soon to tell if ADHD drugs really increase cardiovascular risk and that it was “pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD.” Among the options, the FDA said, was long-term safety trials to look at cardiovascular risks.

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