Drug Maker Acknowledges Misleading Statements

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Drug Maker Acknowledges Misleading Statements

Jul 24, 2004 5:34 pm US/Central

TRENTON (AP) The maker of a popular medicine for schizophrenia has notified

doctors that it minimized potentially fatal safety risks and made misleading

claims about the drug in promotional materials.

Janssen Pharmaceutica Products sent a two-page letter to the health care

community this past week to clarify the risks of Risperdal, Carol Goodrich, a

spokeswoman for the & subsidiary, said Saturday.

The letter stems from a directive issued last year by the Food and Drug

Administration, which told several makers of anti-psychotic drugs to update

their product labels.

Janssen complied in November 2003, but the FDA determined that the company's

promotional materials still minimized the risk of strokes, diabetes and other

potentially fatal complications. The agency also said Janssen made misleading

claims that the medication was safer in treating mental illness than similar

drugs.

The Miami Herald reported Saturday that a handful of boys in Florida developed

lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was

cited in a federal lawsuit filed earlier this month by a doctor who claims

children have been harmed and even killed by the misuse of drugs he blames on

aggressive marketing by drug manufacturers.

" The FDA did not think we had (initially) provided enough information, so that

is why further notification was done, " Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of

psychotic disorders, earning Janssen about $2.1 billion in annual sales. The

drug was first marketed about eight years ago.

(© 2004 The Associated Press. . This material may not be

published, broadcast, rewritten, or redistributed. )

[Guest guest]

http://keyetv.com/siteSearch/health_story_206220314.html

Drug Maker Acknowledges Misleading Statements

Jul 24, 2004 5:34 pm US/Central

TRENTON (AP) The maker of a popular medicine for schizophrenia has notified

doctors that it minimized potentially fatal safety risks and made misleading

claims about the drug in promotional materials.

Janssen Pharmaceutica Products sent a two-page letter to the health care

community this past week to clarify the risks of Risperdal, Carol Goodrich, a

spokeswoman for the & subsidiary, said Saturday.

The letter stems from a directive issued last year by the Food and Drug

Administration, which told several makers of anti-psychotic drugs to update

their product labels.

Janssen complied in November 2003, but the FDA determined that the company's

promotional materials still minimized the risk of strokes, diabetes and other

potentially fatal complications. The agency also said Janssen made misleading

claims that the medication was safer in treating mental illness than similar

drugs.

The Miami Herald reported Saturday that a handful of boys in Florida developed

lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was

cited in a federal lawsuit filed earlier this month by a doctor who claims

children have been harmed and even killed by the misuse of drugs he blames on

aggressive marketing by drug manufacturers.

" The FDA did not think we had (initially) provided enough information, so that

is why further notification was done, " Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of

psychotic disorders, earning Janssen about $2.1 billion in annual sales. The

drug was first marketed about eight years ago.

(© 2004 The Associated Press. . This material may not be

published, broadcast, rewritten, or redistributed. )

[Guest guest]

http://keyetv.com/siteSearch/health_story_206220314.html

Drug Maker Acknowledges Misleading Statements

Jul 24, 2004 5:34 pm US/Central

TRENTON (AP) The maker of a popular medicine for schizophrenia has notified

doctors that it minimized potentially fatal safety risks and made misleading

claims about the drug in promotional materials.

Janssen Pharmaceutica Products sent a two-page letter to the health care

community this past week to clarify the risks of Risperdal, Carol Goodrich, a

spokeswoman for the & subsidiary, said Saturday.

The letter stems from a directive issued last year by the Food and Drug

Administration, which told several makers of anti-psychotic drugs to update

their product labels.

Janssen complied in November 2003, but the FDA determined that the company's

promotional materials still minimized the risk of strokes, diabetes and other

potentially fatal complications. The agency also said Janssen made misleading

claims that the medication was safer in treating mental illness than similar

drugs.

The Miami Herald reported Saturday that a handful of boys in Florida developed

lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was

cited in a federal lawsuit filed earlier this month by a doctor who claims

children have been harmed and even killed by the misuse of drugs he blames on

aggressive marketing by drug manufacturers.

" The FDA did not think we had (initially) provided enough information, so that

is why further notification was done, " Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of

psychotic disorders, earning Janssen about $2.1 billion in annual sales. The

drug was first marketed about eight years ago.

(© 2004 The Associated Press. . This material may not be

published, broadcast, rewritten, or redistributed. )

[Guest guest]

http://keyetv.com/siteSearch/health_story_206220314.html

Drug Maker Acknowledges Misleading Statements

Jul 24, 2004 5:34 pm US/Central

TRENTON (AP) The maker of a popular medicine for schizophrenia has notified

doctors that it minimized potentially fatal safety risks and made misleading

claims about the drug in promotional materials.

Janssen Pharmaceutica Products sent a two-page letter to the health care

community this past week to clarify the risks of Risperdal, Carol Goodrich, a

spokeswoman for the & subsidiary, said Saturday.

The letter stems from a directive issued last year by the Food and Drug

Administration, which told several makers of anti-psychotic drugs to update

their product labels.

Janssen complied in November 2003, but the FDA determined that the company's

promotional materials still minimized the risk of strokes, diabetes and other

potentially fatal complications. The agency also said Janssen made misleading

claims that the medication was safer in treating mental illness than similar

drugs.

The Miami Herald reported Saturday that a handful of boys in Florida developed

lactating breasts after taking Risperdal.

The drug, which is prescribed to more than 10 million people worldwide, was

cited in a federal lawsuit filed earlier this month by a doctor who claims

children have been harmed and even killed by the misuse of drugs he blames on

aggressive marketing by drug manufacturers.

" The FDA did not think we had (initially) provided enough information, so that

is why further notification was done, " Goodrich said.

Risperdal is the leading drug used to combat schizophrenia and other types of

psychotic disorders, earning Janssen about $2.1 billion in annual sales. The

drug was first marketed about eight years ago.

(© 2004 The Associated Press. . This material may not be

published, broadcast, rewritten, or redistributed. )