/// ACTION ALERT /// April 20, 2006 /// NPA Calls for Strongest Warning for Rita

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/// ACTION ALERT /// April 20, 2006 ///

 

NPA Calls for Strongest Warning for Ritalin and Similar Drugs

 

Every day psychiatrists, paediatricians and other practitioners break laws in

many U.S. states and across Canada when prescribing psychotropic drugs. Per

informed consent legislation patients must be made aware of all major and

minor risks associated with medications. Yet we have yet to find one case where

this happened.

 

For example, when one mother asked her son’s psychiatrist about Ritalin, the

totality of the information he gave her was “It’s good for him.†This is

illegal because it violates Informed Consent. This drug was the subject of a

public warning by Health Canada just last month and is a controlled substance,

in

the same category as cocaine. It has also been associated with numerous

deaths of children and adults and has a significant array of potential side

effects, ranging from lack of diet to liver failure. (The basis of our recent

petition seeking a class action lawsuit in Quebec is based on violations of

informed

consent.)

 

This failure in the healthcare industry must be addressed (and actions are

already under way to make sure this happens). In the meanwhile, it is vital

that the government agencies that are responsible for keeping the public safe

act

to ensure that consumers are aware of the risks associated with all

medication. One way they can do this is make sure that vital information about

drugs

is included on the label.

 

The U.S. Food and Drug Administration are currently reviewing whether they

should issue their strongest warning, called a “black box,†for “ADHDâ€

drugs

such as Ritalin, Concerta and Adderall. We strongly feel that they should and

have sent a letter to the Acting Commissioner of the FDA (copy below).

 

We are also urging all our members to do the same (please send us a copy).

 

Thank you for your support.

National Parents Association

info

 

 

Andrew C. von Eschenbach, M.D.

Acting Commissioner

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857-0001

Email: andrew.voneschenbach

 

 

Dear Sir,

 

I am the president of the National Parents Association, a group established

to protect the rights of parents and to preserve the family. There is a case

of a 12-year old boy (Gabriel Lavigueur) that has been the subject of media

attention here in Canada for the past three weeks. Last week a petition seeking

a class action lawsuit was filed in court based on his case.

 

At the heart of the issue is Informed Consent. The boy was placed on

Ritalin, Risperdal and Paxil simultaneously. The mother was not advised of any

of

the major or minor risks associated with these drugs – including the fact that

both Risperdal and Paxil are not approved by Health Canada for use in pediatric

patients. Yes, it’s true that if she went on your website or the counterpart

in Canada that she would have found out. But how many parents do you know

that know that such resources even exist? Labeling changes and more public

warnings must be issued – and they must be of a severity on par with the

dangers

of the drugs they’re associated with.

 

 

I have been following the recent events with the FDA regarding ADHD

medications and I am writing to urge you to issue a Black Box warning on these

drugs.

To not do so leaves parents and children at risk. After all, what’s the point

of “labeling changes†if drug companies can advertise their wares direct to

the consumer to the tune of $3.1 billion (in the United States) per annum, and

not have to include the warnings?

 

I trust that you will do the right thing and issue the Black Box. It is

important for America and for Canada as what you do has influence on this side

of

the border.

 

 

Sincerely,

 

George A. Mentis

 

President

National Parents Association

 

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