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http://www.nj.com/business/ledger/index.ssf?/base/business-0/108425959826730.xml

Antidepressant prescriptions show decline

Drop follows FDA meeting on links to suicides in kids

Tuesday, May 11, 2004

BY ED SILVERMAN

Star-Ledger Staff

The number of new prescriptions written for antidepressants has dropped by 10

percent since a government meeting was held earlier this year to review

suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during

early February, when a Food and Drug Administration panel met to explore

scientific data. The meeting drew national publicity when some parents told how

their children attempted or committed suicide after taking of one of the drugs.

Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were

told to put warnings on product labels. As of April 23, the number of new

prescriptions per week was about 996,000, according to NDC Health, a market

research firm that tracks prescription data.

" Depression still exists. I see it in my office every day, " said Roy Boorady, an

assistant psychiatry professor at New York University School of Medicine's Child

Study Center. " But in talking to my colleagues, I know we've all been more

cautious prescribing these medications. "

The data also shows the total number of new and refilled prescriptions fell 6

percent over the same period, and is the latest indication that the controversy

over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say

antidepressants are life-savers, which helps explain why the drugs generated

more than $11 billion in retail sales last year. But critics say the alleged

links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing

previously unpublished safety data from pharmaceutical companies, urged

physicians not to prescribe most of the medicines to children. Their list

included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an

advisory panel in February. But after the meeting, the agency was criticized by

consumer advocates for allegedly silencing its own medical reviewer, who wanted

to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on

product labeling and asked Columbia University researchers to review side effect

data. A report is expected this summer. But the agency was chastised by angry

parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA's

handling of its medical reviewer. The agency denied silencing the reviewer and

defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee,

said the agency's action raised " troubling questions " and that he may hold

hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs.

Only Prozac was approved for children in the United States, but doctors can

prescribe any medication. Drug makers are also under pressure to release

unpublished clinical trial data, which critics say may contain negative

information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@....

Copyright 2004 NJ.com. .

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

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http://www.nj.com/business/ledger/index.ssf?/base/business-0/108425959826730.xml

Antidepressant prescriptions show decline

Drop follows FDA meeting on links to suicides in kids

Tuesday, May 11, 2004

BY ED SILVERMAN

Star-Ledger Staff

The number of new prescriptions written for antidepressants has dropped by 10

percent since a government meeting was held earlier this year to review

suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during

early February, when a Food and Drug Administration panel met to explore

scientific data. The meeting drew national publicity when some parents told how

their children attempted or committed suicide after taking of one of the drugs.

Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were

told to put warnings on product labels. As of April 23, the number of new

prescriptions per week was about 996,000, according to NDC Health, a market

research firm that tracks prescription data.

" Depression still exists. I see it in my office every day, " said Roy Boorady, an

assistant psychiatry professor at New York University School of Medicine's Child

Study Center. " But in talking to my colleagues, I know we've all been more

cautious prescribing these medications. "

The data also shows the total number of new and refilled prescriptions fell 6

percent over the same period, and is the latest indication that the controversy

over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say

antidepressants are life-savers, which helps explain why the drugs generated

more than $11 billion in retail sales last year. But critics say the alleged

links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing

previously unpublished safety data from pharmaceutical companies, urged

physicians not to prescribe most of the medicines to children. Their list

included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an

advisory panel in February. But after the meeting, the agency was criticized by

consumer advocates for allegedly silencing its own medical reviewer, who wanted

to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on

product labeling and asked Columbia University researchers to review side effect

data. A report is expected this summer. But the agency was chastised by angry

parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA's

handling of its medical reviewer. The agency denied silencing the reviewer and

defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee,

said the agency's action raised " troubling questions " and that he may hold

hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs.

Only Prozac was approved for children in the United States, but doctors can

prescribe any medication. Drug makers are also under pressure to release

unpublished clinical trial data, which critics say may contain negative

information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@....

Copyright 2004 NJ.com. .

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

Link to comment
Share on other sites

Guest guest

http://www.nj.com/business/ledger/index.ssf?/base/business-0/108425959826730.xml

Antidepressant prescriptions show decline

Drop follows FDA meeting on links to suicides in kids

Tuesday, May 11, 2004

BY ED SILVERMAN

Star-Ledger Staff

The number of new prescriptions written for antidepressants has dropped by 10

percent since a government meeting was held earlier this year to review

suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during

early February, when a Food and Drug Administration panel met to explore

scientific data. The meeting drew national publicity when some parents told how

their children attempted or committed suicide after taking of one of the drugs.

Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were

told to put warnings on product labels. As of April 23, the number of new

prescriptions per week was about 996,000, according to NDC Health, a market

research firm that tracks prescription data.

" Depression still exists. I see it in my office every day, " said Roy Boorady, an

assistant psychiatry professor at New York University School of Medicine's Child

Study Center. " But in talking to my colleagues, I know we've all been more

cautious prescribing these medications. "

The data also shows the total number of new and refilled prescriptions fell 6

percent over the same period, and is the latest indication that the controversy

over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say

antidepressants are life-savers, which helps explain why the drugs generated

more than $11 billion in retail sales last year. But critics say the alleged

links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing

previously unpublished safety data from pharmaceutical companies, urged

physicians not to prescribe most of the medicines to children. Their list

included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an

advisory panel in February. But after the meeting, the agency was criticized by

consumer advocates for allegedly silencing its own medical reviewer, who wanted

to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on

product labeling and asked Columbia University researchers to review side effect

data. A report is expected this summer. But the agency was chastised by angry

parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA's

handling of its medical reviewer. The agency denied silencing the reviewer and

defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee,

said the agency's action raised " troubling questions " and that he may hold

hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs.

Only Prozac was approved for children in the United States, but doctors can

prescribe any medication. Drug makers are also under pressure to release

unpublished clinical trial data, which critics say may contain negative

information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@....

Copyright 2004 NJ.com. .

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

Link to comment
Share on other sites

Guest guest

http://www.nj.com/business/ledger/index.ssf?/base/business-0/108425959826730.xml

Antidepressant prescriptions show decline

Drop follows FDA meeting on links to suicides in kids

Tuesday, May 11, 2004

BY ED SILVERMAN

Star-Ledger Staff

The number of new prescriptions written for antidepressants has dropped by 10

percent since a government meeting was held earlier this year to review

suspected links to suicide.

Doctors wrote new prescriptions at a rate of nearly 1.1 million per week during

early February, when a Food and Drug Administration panel met to explore

scientific data. The meeting drew national publicity when some parents told how

their children attempted or committed suicide after taking of one of the drugs.

Prescriptions then began to drop.

By late March, the number rebounded, but dipped again after drug makers were

told to put warnings on product labels. As of April 23, the number of new

prescriptions per week was about 996,000, according to NDC Health, a market

research firm that tracks prescription data.

" Depression still exists. I see it in my office every day, " said Roy Boorady, an

assistant psychiatry professor at New York University School of Medicine's Child

Study Center. " But in talking to my colleagues, I know we've all been more

cautious prescribing these medications. "

The data also shows the total number of new and refilled prescriptions fell 6

percent over the same period, and is the latest indication that the controversy

over antidepressants is widening.

The debate, however, is not clear-cut. Many parents and physicians say

antidepressants are life-savers, which helps explain why the drugs generated

more than $11 billion in retail sales last year. But critics say the alleged

links to suicide, especially among children, demand greater restrictions.

The issue drew attention last summer after British medical authorities, citing

previously unpublished safety data from pharmaceutical companies, urged

physicians not to prescribe most of the medicines to children. Their list

included Zoloft, Celexa, Paxil and Effexor, but not Prozac.

In an unusual response to growing pleas by American families, the FDA held an

advisory panel in February. But after the meeting, the agency was criticized by

consumer advocates for allegedly silencing its own medical reviewer, who wanted

to propose restrictions on prescriptions, according to FDA documents.

In late March, the FDA told drug makers to issue warnings about suicide on

product labeling and asked Columbia University researchers to review side effect

data. A report is expected this summer. But the agency was chastised by angry

parents for failing to take the same steps as their British counterparts.

As a result, the House Energy and Commerce Committee is investigating the FDA's

handling of its medical reviewer. The agency denied silencing the reviewer and

defended its decisions, but Rep. Joe Barton (R-Texas), who chairs the committee,

said the agency's action raised " troubling questions " and that he may hold

hearings.

The controversy, meanwhile, has renewed concern about off-label usage of drugs.

Only Prozac was approved for children in the United States, but doctors can

prescribe any medication. Drug makers are also under pressure to release

unpublished clinical trial data, which critics say may contain negative

information that would otherwise remain suppressed.

Ed Silverman can be reached at (973) 392-1542 or esilverman@....

Copyright 2004 NJ.com. .

Jim - Norman

" Never look at the trombones, it only encourages them. "

Strauss

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