Re: fw: Risperdal Maker Acknowledges Misleading Claims

[Guest guest]

My boss received a copy of this letter today.

For those of you have children on Risperdal, it seems the primary focus of

this letter is on the risk of developing hyperglycemia and the dangerous

complications that can arise from that. It recommends patients observe for

the usual signs of high blood sugar, excessive thirstiness, hungriness,

always peeing, and weakness. Of course I am not a doctor, I just want to

alleviate concern. Do talk to your doctor about the letter and maybe they

can show you a copy.

As with any medication one has to be very clear about what symptoms you are

treating, the potential side effects of the medication, and then determine

if the medication is worth it or not.

It is easy to get caught in the extremes of the issues of medications, all

or none, but really what we want when medications are needed are the least

amount of the right medication to handle the problem without causing more

harm. Of course that takes communication and accurate information from your

doctor (and the drug companies).

Kim L

>

>>

>> http://www.abcnews.go.com/wire/US/ap20040724_723.html

>>

>> Drug Maker Acknowledges Misleading Claims

>> Drug Maker Acknowledges Making Misleading Statements About Popular

>> Schizophrenia Drug

>>

>> The Associated Press

>>

>> TRENTON, N.J. July 24, 2004 — 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 Pharmaceutic 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.

>

>

>

>

> Membership of this email support groups does not constitute membership in the

> CHARGE Syndrome Foundation.

> For information about the CHARGE Syndrome

> Foundation or to become a member (and get the newsletter)

> please contact marion@... or visit

> the CHARGE Syndrome Foundation web page

> at http://www.chargesyndrome.org

> 7th International

> CHARGE Syndrome Conference, Miami Beach, Florida, July 22-24, 2005.

> Information will be available at our website

> www.chargesyndrome.org or by calling 1-. In Canada, you may

> contact CHARGE Syndrome Canada at 1- (families), visit

> www.chargesyndrome.ca, or email info@.... Thank you!

>

>

[Guest guest]

My boss received a copy of this letter today.

For those of you have children on Risperdal, it seems the primary focus of

this letter is on the risk of developing hyperglycemia and the dangerous

complications that can arise from that. It recommends patients observe for

the usual signs of high blood sugar, excessive thirstiness, hungriness,

always peeing, and weakness. Of course I am not a doctor, I just want to

alleviate concern. Do talk to your doctor about the letter and maybe they

can show you a copy.

As with any medication one has to be very clear about what symptoms you are

treating, the potential side effects of the medication, and then determine

if the medication is worth it or not.

It is easy to get caught in the extremes of the issues of medications, all

or none, but really what we want when medications are needed are the least

amount of the right medication to handle the problem without causing more

harm. Of course that takes communication and accurate information from your

doctor (and the drug companies).

Kim L

>

>>

>> http://www.abcnews.go.com/wire/US/ap20040724_723.html

>>

>> Drug Maker Acknowledges Misleading Claims

>> Drug Maker Acknowledges Making Misleading Statements About Popular

>> Schizophrenia Drug

>>

>> The Associated Press

>>

>> TRENTON, N.J. July 24, 2004 — 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 Pharmaceutic 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.

>

>

>

>

> Membership of this email support groups does not constitute membership in the

> CHARGE Syndrome Foundation.

> For information about the CHARGE Syndrome

> Foundation or to become a member (and get the newsletter)

> please contact marion@... or visit

> the CHARGE Syndrome Foundation web page

> at http://www.chargesyndrome.org

> 7th International

> CHARGE Syndrome Conference, Miami Beach, Florida, July 22-24, 2005.

> Information will be available at our website

> www.chargesyndrome.org or by calling 1-. In Canada, you may

> contact CHARGE Syndrome Canada at 1- (families), visit

> www.chargesyndrome.ca, or email info@.... Thank you!

>

>

[Guest guest]

My boss received a copy of this letter today.

For those of you have children on Risperdal, it seems the primary focus of

this letter is on the risk of developing hyperglycemia and the dangerous

complications that can arise from that. It recommends patients observe for

the usual signs of high blood sugar, excessive thirstiness, hungriness,

always peeing, and weakness. Of course I am not a doctor, I just want to

alleviate concern. Do talk to your doctor about the letter and maybe they

can show you a copy.

As with any medication one has to be very clear about what symptoms you are

treating, the potential side effects of the medication, and then determine

if the medication is worth it or not.

It is easy to get caught in the extremes of the issues of medications, all

or none, but really what we want when medications are needed are the least

amount of the right medication to handle the problem without causing more

harm. Of course that takes communication and accurate information from your

doctor (and the drug companies).

Kim L

>

>>

>> http://www.abcnews.go.com/wire/US/ap20040724_723.html

>>

>> Drug Maker Acknowledges Misleading Claims

>> Drug Maker Acknowledges Making Misleading Statements About Popular

>> Schizophrenia Drug

>>

>> The Associated Press

>>

>> TRENTON, N.J. July 24, 2004 — 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 Pharmaceutic 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.

>

>

>

>

> Membership of this email support groups does not constitute membership in the

> CHARGE Syndrome Foundation.

> For information about the CHARGE Syndrome

> Foundation or to become a member (and get the newsletter)

> please contact marion@... or visit

> the CHARGE Syndrome Foundation web page

> at http://www.chargesyndrome.org

> 7th International

> CHARGE Syndrome Conference, Miami Beach, Florida, July 22-24, 2005.

> Information will be available at our website

> www.chargesyndrome.org or by calling 1-. In Canada, you may

> contact CHARGE Syndrome Canada at 1- (families), visit

> www.chargesyndrome.ca, or email info@.... Thank you!

>

>

[Guest guest]

Hi Kim L and co,

I work with adults with mental health problems, a lot of who use risperdal

(I know it more commonly as risperidone so excuse me if I interchange in use

of names). We have been aware for some time now that the newer atypical

antipsychotic medications do present a risk of the onset of diabetes

(basically a number of our clients using these meds have had the onset).

The main drugs are risperidone and olanzapine (sorry, can't think what the

other name for olanzapine is).

I agree with you Kim, that one has to weigh up the benefits against the

risks and research each medication thoroughly so that they are aware enough

to be vigilant about the potential side effects and to negotiate the lowest

therapeutic dosage with the prescriber. I am, however, really disappointed

that with the knowledge our psychiatrists have about the risk of

hyperglycaemia, they continue not to pass the information to their patients,

I guess because there is the risk that they may refuse to take the meds. I

think this is actually very irresponsible. Guess this leaves the onus on us

to carry out the research, but I agree that the bigger picture is difficult

to look at in terms of all or nothing. I am no medic either but thought I

would put in my two pennies' worth.

Flo