News and Document archive source
copyrighted material disclaimer at bottom of page

NewsMinecabal-elitecorporatepharmaceutical — Viewing Item


Ritalin could be dangerous to heart { February 10 2006 }

Original Source Link: (May no longer be active)
   http://www.nytimes.com/2006/02/10/health/policy/10drug.html

http://www.nytimes.com/2006/02/10/health/policy/10drug.html

February 10, 2006
Panel Advises Risk Warning on Stimulants
By GARDINER HARRIS

GAITHERSBURG, Md., Feb. 9 Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.

The panel's recommendation promises to intensify a long-running debate about whether the medicines are overused. Nearly four million patients take the drugs to treat attention deficit disorder and hyperactivity, and committee members said they wanted to slow explosive growth in the drugs' use.

The committee's action was unexpected. The Food and Drug Administration had convened the panel to help it determine how to research possible heart risks of the drugs. The agency had not asked the committee to address the drugs' labels, and agency officials seemed taken aback by the votes, saying they would not act on the committee's recommendations anytime soon.

"We don't think anything different needs to be done right now," Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency, said at a hastily arranged news conference after the meeting. "We think the labeling right now is adequate."

The committee voted unanimously to recommend patient guides, and it voted 8 to 7 to suggest that stimulant labels carry the most serious of the agency's drug-risk warnings a "black box."

"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member.

The votes came after F.D.A. medical officers described reports of 25 sudden deaths among people taking stimulants the deaths were mostly children and a preliminary analysis of millions of health records that suggested stimulants might increase the risks of strokes and serious arrhythmias in children and adults. The reports of sudden deaths never exceeded one in a million for any stimulant drug, although the F.D.A. usually receives reports of only a fraction of drug problems.

The preliminary analysis suggested that the stimulants might increase heart risks more than twofold. Such an increase may not be significant in children, whose heart risks are low, but could cause concern in adults, panel members said.

One of the drugs, Ritalin, has been marketed since 1955, and dozens of studies have shown it to be safe and effective. But no studies have been of sufficient duration or included enough participants to evaluate stimulants' long-term effects on the heart.

But the drugs' soaring popularity and increasing use in adults, panel members said, mean that the F.D.A. should study them more closely and warn patients and doctors about the potential risks to the heart.

Arthur A. Levin, director of the Center for Medical Consumers in New York City and a member of the panel, said that patients assumed that stimulants were safe, but that that confidence was misplaced.

"For us to sit around and talk about it, and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks, would be unethical," Mr. Levin said.

Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart.

The committee was composed largely of drug-safety specialists. Next month, the F.D.A. will ask another committee, mostly pediatricians and psychiatrists, to weigh the same issues. Such clinicians tend to focus on drug benefits and oppose warnings that might scare patients.

The vote by the drug-safety panel reflects changing notions about what the drug agency should do in the face of uncertainty. For decades, it generally refused to warn doctors about theoretical medical risks, even when there were strong hints of danger. But the committee said such silence was a mistake, particularly when millions took the drugs.

"Put yourself in our shoes," said Dr. Peter A. Gross of Hackensack University Medical Center in New Jersey and the panel's chairman. "Most of us see our role as protecting the public health. As often happens, the data we would like to see is not clear. In that setting, what we would like to see is a clearer warning."

But top F.D.A. officials said warning patients about theoretical risks might scare many away from needed treatment. "I think it's important not to minimize the benefits of these drugs," Dr. Laughren said.

Representatives of Johnson & Johnson, the maker of Concerta, and Shire, the maker of Adderall, two stimulants, said they would work with the drug agency on any label changes.

Dr. Todd Gruber, an executive of Novartis, which makes Ritalin, has said that Novartis has found no evidence that the drug raises the risks of heart problems.

Stimulants are the most widely prescribed medicine for childhood behavioral problems. Data presented at the meeting suggest that about 2.5 million children and 1.5 million adults are taking them. More than 30 million prescriptions for the drugs are written annually.

Several F.D.A. medical officers addressed the committee, and each suggested that the risks could be significant. Dr. Kate Gelperin, a medical officer in the Office of Drug Safety at the agency, began her presentation by telling the committee, "This morning I'm going to tell you a little bit about why the F.D.A. is so worried about these issues."

Dr. Gelperin noted that stimulants had long been known to increase blood pressure and heart rates. Other studies have shown conclusively that increased blood pressure leads directly to increased deaths from heart problems, she said.

Dr. Andrew Mosholder, also a medical officer in the Office of Drug Safety, said he reviewed the chemical structures of stimulants, and he noted that these structures were similar to drugs like ephedrine that had proven heart risks.

Dr. David Graham, another medical officer in the drug safety office, described the agency's preliminary analysis of millions of medical records that suggested an increased risk of strokes and arrhythmias.

"The number of arrhythmia hospitalizations really struck us as surprising," Dr. Graham said. "Arrhythmia is believed to be the pathway for sudden unexplained death."

In an interview after his presentation, Dr. Graham said, "There's smoke. Does that represent a fire? We want to answer that question."

After hearing the presentations, most committee members decided they should do more than simply make suggestions for further research.

"I want to cause people's hands to tremble a little bit before they write that prescription," Dr. Nissen said.

Psychiatrists and psychologists who treat and study attention deficit disorder and hyperactivity were deeply divided over the decision.

"I'm not saying a warning would be baseless, but if we're not careful we're going to engage in a Chicken Little scenario in which we sensationalize what is a very, very low-probability event," said Dr. Russell Barkley, a research professor of psychiatry at the State University of New York Upstate Medical University in Syracuse.

Others said that a black-box warning could prompt families to explore behavioral treatments as an alternative to drugs, which "would be a very good outcome for kids with A.D.H.D. and their families," said William Pelham, director of the Center for Children and Families at the State University of New York at Buffalo.

All agreed that parents of children on stimulants who have pre-existing heart conditions should consult their doctors.

Benedict Carey contributed reporting from New York for this article.



Copyright 2006 The New York Times Company


40 percent of americans take prescription drugs
ADD drugs give hallucinations of bugs and snakes { March 22 2006 }
American painkiller use skyrocketing
Anti depresents linked to suicide
Antibiotic causes liver damage
Antidepressant use by adults surges { December 3 2004 }
Antidepressants addictive to some people { August 6 2006 }
Antidepressants remove obsessive focus of love
Antidepressiants increases chance of suicide { December 13 2006 }
Arthritis drugs causing cancer in childen { April 29 2008 }
Bayer sent riskier drug asia latinamerica { May 22 2003 }
Birth defects from paxil in pregnant women { December 8 2005 }
Canada makes drug deals with 2 states against fda wishes { October 5 2004 }
Cholesterol drug causes kidney damage contradicting fda { May 24 2005 }
Cholesterol meds lower test results not improving health { January 15 2008 }
Clinical trials biased by profit funding
Company hid heartattack data for painkiller { December 8 2005 }
Congressman moves retired to drug lobby
Dc council legislation blocks pharmaceutical price gounging { September 21 2005 }
Doctor gives anti depressants to 4 yr old girl
Doctors get kickbacks to promote drugs
Doctors prescribe paxil whenever asked { April 27 2005 }
Drug aleve increases stroke heart attack risk { December 21 2004 }
Drug bill well financed victory
Drug company criminal charges { May 31 2003 }
Drug firms hide studies showing suicidal behavior { September 10 2004 }
Drug firms hype up diseases to boost sales
Drug leader at NIH takes pharmaceutical money { December 22 2004 }
Fda accused too cozy with pharmaceuticals { November 18 2004 }
Fda approval surprises many doctors
Fda prevented drug expert from speaking on anti depressants { April 16 2004 }
Fda wants suicide warning on anti depressants { March 23 2004 }
Fda whistle blower seeks legal help { November 24 2004 }
Fraud studies made by drug company { March 2008 }
Man arrested if not medicating child with drugs { June 7 2004 }
Mccain knocks steroids baseball
Minnesota school shooter using prozac and others { March 26 2005 }
More anti depressant drug warnings by fda
New diabetes pill poses deadly risk
New york state sues paxil company over coverup { June 3 2004 }
Newer antipsychotic drugs more costly less effective { September 20 2005 }
Parents reverse child hyper activity without drugs { December 22 2006 }
Paxil link found with birth defects
Pharmaceutical cholesterol drugs not lowering risk
Pharmaceutical companies court doctors for sells { April 11 2008 }
Pharmaceutical companies using tax exempt charities { June 28 2006 }
Pharmaceutical secrecy on antidepressant data { January 29 2004 }
Pharmaceuticals in tap water through sewage { March 10 2008 }
Pharmaceuticals pay fda more for speedy approvals { November 22 2006 }
Return of vioxx unusual not unprecendented
Rise of european behavior controlling drug
Ritalin could be dangerous to heart { February 10 2006 }
Senators told fda too cozy with drug industry { November 18 2004 }
Sharp rise in ritalin { July 19 2003 }
Sleeping pill causes sleep driving { March 15 2007 }
Sleeping pills once a day increase death rate { March 23 2006 }
Statin drug takers suffer heart attacks anyway
Study criticizes painkiller marketing { January 25 2005 }
Study drugs for students growing { June 11 2006 }
Study shows no good effect from anti depressants { February 25 2008 }
Suicide risk increase with antidepressants { February 18 2005 }
Supreme court allows pharmaceutical to bulldoze homes { June 23 2005 }
Teens increasing pharmaceutical drug abuse { April 21 2005 }
Teens use pharmaceutical drugs to get high { December 21 2006 }
Unapproved drug tested on children in nigeria { May 7 2006 }
Unfavorable drug studies never reported
Viox risk seen with short term use { May 17 2006 }
Women participating in lilly drug trial hangs self { February 9 2004 }

Files Listed: 68



Correction/submissions

CIA FOIA Archive

National Security
Archives
Support one-state solution for Israel and Palestine Tea Party bumper stickers JFK for Dummies, The Assassination made simple