Janssen Pharma Admits Hiding Risperdal drug risks - boys develop lactating breasts

[Guest guest]

> JustSayNo

> Sat, 24 Jul 2004 22:07:58 -0000

> [sSRI-Research] Janssen Pharma Admits

> Hiding Risperdal drug risks - boys develop lactating

> breasts

>

> ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

> Promoting openness and full disclosure

> http://www.ahrp.org

>

> FYI

>

> The Miami Herald reports (below) that in a letter to

> doctors, Janssen

> Pharmacia, manufacturer of the highly promoted drug,

> Risperdal

> (risperidone), admitted " misleading doctors and

> other healthcare

> providers about the safety of its product,

> minimizing potentially

> deadly side effects. " As late as Nov. 10, 2003,

> Janssen claimed

> Risperdal did not increase the risk of diabetes

> among consumers--when

> the company knew the opposite was true.

>

> " The drug, Risperdal, has been commonly prescribed

> to Florida

> children in state care, including to a handful of

> boys who developed

> lactating breasts after taking it. "

>

> Circuit Judge John A. Frusciante, said Risperdal

> continues to be used

> frequently by doctors who treat children in state

> care. ''It is not

> uncommon,'' he said, noting:

> " This whole psychotropic drug issue is a problem for

> us. It's a very

> scary area to be in, because we know medication can

> be a tremendous

> help for a number of children. But we also know that

> there are risks

> to the children who are taking these medications.''

>

>

----

>

> http://www.miami.com/mld/miamiherald/9231611.htm?

> template=contentModules/printstory.jsp

>

> MIAMI HERLAD / CHILD WELFARE

>

> Maker of drug admits hiding its risks

>

> Posted on Sat, Jul. 24, 2004

>

> BY CAROL MARBIN MILLER

> cmarbin

>

> The maker of a billion-dollar antipsychotic

> medication has

> acknowledged misleading doctors and other healthcare

> providers about

> the safety of its product, minimizing potentially

> deadly side effects.

>

> The drug, Risperdal, has been commonly prescribed to

> Florida children

> in state care, including to a handful of boys who

> developed lactating

> breasts after taking it.

>

> On Wednesday, drug maker Janssen Pharmaceutica wrote

> a two-page

> letter to doctors, warning them that the company, in

> promotional

> material, had ''minimized potentially fatal risks,

> and made

> misleading claims'' that the medication was more

> safe in treating

> mental illness than other drugs in the same

> category.

>

> Most physicians received the letter Friday.

>

> 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, and

> is prescribed to more than 10 million people

> worldwide.

>

> The ''important correction of drug information''

> came shortly after

> federal regulators had accused Janssen of

> ''disseminating''

> advertising and marketing material that was ``false

> or misleading.''

>

> A letter from Janssen to doctors, dated Nov. 10,

> 2003, claimed

> Risperdal did not increase the risk of diabetes

> among consumers

> compared with other similar drugs, called

> neuroleptics or

> antipsychotics.

>

> But an April 2004 letter from the U.S. Department of

> Health and Human

> Services to Janssen asserts quite the contrary.

> Research

> indicated ''an increased risk of

> hyperglycemia-related adverse

> effects and diabetes with Risperdal,'' the letter

> stated.

>

> A TROUBLED HISTORY

>

> In 2001, The Herald published a series of stories

> about the common

> use of Risperdal among children in state care.

> Child-welfare

> advocates said the drug routinely was being used by

> foster care

> providers as a ''chemical restraint'' on children

> whose unruly

> behavior was a frustration to caretakers.

>

> ''I had clients who were displaying severe side

> effects, and I tried

> to alert the Department of Children & Families both

> as to the local

> problem and the growing national concern about a

> range of

> psychotropic medications, Risperdal and other

> antipsychotics in

> particular,'' said Coral Springs attorney and

> children's advocate

> Andrea Moore.

>

> ''They listened, but they did not hear me,'' Moore

> added.

>

> Broward Circuit Judge John A. Frusciante, who must

> approve requests

> from doctors before they can prescribe mind-altering

> drugs to

> children whose cases he oversees, said Risperdal

> continues to be used

> frequently by doctors who treat children in state

> care.

>

> ''It is not uncommon,'' Frusciante said.

>

> ''This whole psychotropic drug issue is a problem

> for us,''

> Frusciante said. ``It's a very scary area to be in,

> because we know

> medication can be a tremendous help for a number of

> children. But we

> also know that there are risks to the children who

> are taking these

> medications.''

>

> Friday, DCF officials told The Herald they would

> review the new

> material and ask doctors who care for foster

> children to re-evaluate

> their medication options.

>

> ''We will make this information available to all our

> districts,

> program supervisors, community-based care agencies

> and partners,''

> said DCF spokesman Bill Spann. ``In addition, we

> will provide this

> information to all the physicians who care for the

> children in foster

> care, and ask them to review the cases of any

> children who are on the

> drug.

>

> ''We will ask them to take the appropriate action,''

> Spann said.

>

> ONE IN THREE TREATED

>

> The state Agency for Health Care Administration,

> which pays the drug

> bill for most children in state care, as well as

> needy children who

> are insured by Medicaid, could not say Friday how

> many Florida

> Medicaid recipients are being administered the drug.

>

> In 2001, after The Herald's series, DCF reviewed the

> records of most

> foster children. Records showed about about one in

> three foster

> children taking a powerful mood-altering drug. Many

> were taking

> untested combinations, or ''cocktails,'' of the

> drugs.

>

> Infants and toddlers were being given psychiatric

> drugs, according to

> a 2003 study by the Florida Statewide Advocacy

> Council.

>

> Antoinette R. Appel, a Plantation neuropsychologist,

> studied the

> records of about 50 South Florida foster children

> who had been

> prescribed Risperdal.

>

> She said many of the children developed severe

> side-effects,

> including obesity, lethargy, lack of concentration,

> hormonal

> disorders and the inappropriate development of

> secondary sexual

> characteristics, such as lactating breasts in boys

> or young girls.

>

> Carolyn Salisbury, associate director of the

> University of Miami's

> Children & Youth Law Clinic, has pleaded with child

> welfare

> authorities for about five years to curtail the

> widespread use of

> mood-altering drugs among foster kids, who often

> complain the drugs

> make them more ill.

>

> VICTORY IN COURT

>

> One of the clinic's most high-profile clients,

> identified in court

> papers as M.W., won a Florida Supreme Court ruling

> that child welfare

> authorities cannot lock up foster kids in

> psychiatric hospitals

> without a hearing. M.W. had developed lactating

> breasts after doctors

> forced him to take Risperdal, court records show.

>

> One of Salisbury's clients, a 15-year-old girl,

> begged her to prevent

> the child welfare agency from forcing her to take

> Risperdal,

> Salisbury said. The girl had become obese and

> suffered from dramatic

> mood swings, alternating between feeling agitated or

> very depressed.

>

> ''I always object to my foster child clients being

> placed on

> Risperdal . . .,'' Salisbury said. ``However, DCF

> continues to place

> children in their care on the drug, even though DCF

> knows full well

> the horrible side effects foster children continue

> to suffer on this

> drug.''

>

> C 2004 Herald.com

> _______

>