ISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol- 3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-   2-methyl-4H-pyrido[1,2-a]pyrimidin- 4-one. Its molecular formula is C23H27FN4O2.9


“Schizophrenia Drug Maker Admits To Making Misleading Claims”

Health Talk - July 25, 2004

A major US drug maker that produces a popular medicine for schizophrenia is acknowledging that it minimized the risks and made misleading claims in promotional materials for the drug.

Janssen Pharmaceutica Products LP, the maker of Risperdal, has sent a letter to health care providers to clarify the risks involved with the use of Risperdal.

The move comes after the US Federal Drug Administration issued a warning letter to Janssen Pharmaceutica to update their product information.

The FDA said Janssen Pharmaceutica made misleading claims and omitted information regarding hypoglycemia and diabetes.

The warning letter also stated Janssen Pharmaceutica had made misleading claims that 'Risperdal is safer than other atypical antipsychotics'.

"Risperdal is indicated for the treatment of schizophrenia and for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Risperdal is also indicated in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder," according to background information on the drug Risperdal, issued by the FDA in its warning letter.

Worldwide, Risperdal is prescribed to more than 10 million people and accounts for about $2 billion in annual sales.

http://www.healthtalk.ca/misleading_claims_07252004 _8290.php

“Maker of drug admits hiding its risks”

Miami Herald - July 24, 2004

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.


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.


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.


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.''