Maker of drug admits hiding its risks
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 Miami Herald 24.7.2005)
2004 Safety Alert: Risperdal (risperidone) (WARNINGS) - Hyperglycemia and Diabetes Mellitus The following information is from Janssen Pharmaceutica, Inc. Contact the company for a copy of any referenced enclosures. (fda.gov (August 4, 2004))
FDA approves drug for autism symptoms in children
(usatoday.com 6.10.2006)
But this particular drug appears to have some very serious side effects. (latimes.com 20.11.2006)
Antipsykotika
Risperdal (risperidone) Drug Details (fda.gov)
Psykiatri, barn og legemiddelindustriens rolle (nytimes.com 10.5.2007)
US judge fines Johnson & Johnson $1.1bn for misleading marketing of risperidone (Amerikansk dommer ilegger Johnson & Johnson 1,1 milliarder i bot for villedende markedsføring av risperidone)
BMJ 2012;344:e2772 (16 April)
Judge Tim Fox of the Arkansas Circuit Court fined the Johnson & Johnson subsidiary Janssen Pharmaceuticals $1.1bn (£0.7bn; €0.84bn) for promotional information about the antipsychotic drug risperidone that misled the state into spending Medicaid funds for the drug. He also fined the company $11m for violating the state’s law on deceptive practices. Medicaid is a joint federal and state health insurance scheme for people on low incomes. (...)
A jury decided that Johnson & Johnson had defrauded the Medicaid programme. Fox fined the company for 238 000 violations of the state’s Medicaid fraud laws over nearly four years since 2002. He set a fine of $5000 for each violation. (...)
J.&J. Fined $1.2 Billion in Drug Case
nytimes.com 12.4.2012
A judge in Arkansas ordered Johnson & Johnson and a subsidiary to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.
Risperdal is approved to treat schizophrenia, bipolar disorder and behavior problems.
The fine, which experts said ranked among the largest on record for a state fraud case involving a drug company, is the most recent in a string of legal losses for Johnson & Johnson related to its marketing of the drug, Risperdal. (...)
Trial begins in Arkansas over antipsychotic drug
pharmatimes.com 27.3.2012
LITTLE ROCK, Arkansas (AP) — A lawyer for the state of Arkansas told jurors Tuesday that a subsidiary of pharmaceutical company Johnson & Johnson improperly marketed an antipsychotic drug and lied to doctors for years about the risk of side effects.
Arkansas wants Janssen Pharmaceuticals Inc. fined for each of the 250,000 Risperdal prescriptions issued to the state's Medicaid publicly supported patients from November 2002 through June 2006, an award that could range from $1.25 billion to $2.5 billion and would go toward the state's Medicaid fund. (...)
J&J, Merck & Co settle Risperdal, Vioxx cases
pharmatimes.com 20.1.2012
Johnson & Johnson has agreed to pay $158 million to settle a lawsuit in Texas which claimed the healthcare giant and its Janssen unit defrauded the state's Medicaid programme through illegal promotion of the antipsychotic Risperdal.
The case stems from a whistleblower lawsuit filed in 2004 which revealed that J&J launched a campaign promoting Risperdal (risperidone) as the superior drug of choice, while downplaying harmful side effects. The company was accused of improperly urging physicians to prescribe Risperdal to children and the elderly for schizophrenia and dementia, despite the fact that the antipsychotic had not been approved by the US Food and Drug Administration for these uses at the time.
Texas attorney general Greg Abbott said the agreement "sends a strong message that the state will pursue those who defraud Texas taxpayers". He added that J&J’s "scheme to profit from the Medicaid programme by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars". The state had originally sought a settlement of $579 million. (...)
J&J to pay more than $1 billion to settle probe: report
reuters.com 5.1.2012
(Reuters) - Johnson & Johnson is set to pay more than $1 billion to resolve a U.S. civil investigation into the marketing of its Risperdal antipsychotic drug, Bloomberg News reported on Thursday, citing anonymous sources.
The company reached a deal last week with the U.S. attorney in Philadelphia. The deal does not resolve negotiations over a possible criminal plea, the report said.
Johnson & Johnson spokeswoman Teresa Mueller said the company does not comment on rumors or speculation.
In August, J&J said it reached an agreement related to a misdemeanor charge stemming from the Risperdal investigation, although some issues remained unresolved. (...)
Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection
fda.gov (September 2011)
WARNINGS and PRECAUTIONS
Metabolic Changes
Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.
Weight Gain
Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. (...)
Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab (risperidone) orally disintegrating tablets, and Risperdal Consta (risperidone) long-acting injection
fda.gov 13.7.2011
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011
ADVERSE DRUG REACTIONS
Commonly-Observed Adverse Reactions in Double-Blind, Placebo- Controlled Clinical Trials - Autistic Disorder
• In another study with patients treated for irritability associated with autistic disorder, headache (6%), epistaxis (6%) and pyrexia (6%) were also observed in Risperdal-treated pediatric subjects.
Other Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone
• Blood and Lymphatic System Disorders: neutropenia
• Nervous System Disorders: head titubation
Postmarketing Experience
• blood cholesterol increased, blood triglycerides increased
• drug withdrawal syndrome neonatal, dysgeusia (...)
Judge orders drug company to pay SC $327 million (Dommer beordrer legemiddelfirma å betale SC (South Carolina) 327 millioner dollar)
pharmpro.com 3.6.2011
A Johnson & Johnson subsidiary must pay South Carolina $327 million for deceptive marketing of an antipsychotic drug, a Spartanburg County judge ruled Friday.
A spokeswoman for the drugmaker said the company was disappointed and would appeal.
Under the order issued by Circuit Court Judge Roger Couch, Janssen Pharmaceutica Inc. — a subsidiary of the New Brunswick, N.J.-based drug manufacturer — must make the payment for violations of the South Carolina Unfair Trade Practices Act.
"There is absolutely no doubt in my mind that the desire to protect market share overshadowed the good judgment of those in control at Janssen," Couch wrote.
Violations of that law carry potential penalties of up to $5,000 apiece, meaning the company had faced possible consequences of more than $3.1 billion, considering the 620,000 Risperdal prescriptions written for people on Medicaid and the state health plan alone. (...)
According to his order, Couch assessed a $300 penalty per sample box of the drug that was distributed and a $4,000 penalty per publication of the "Dear Doctor" letter, for a total penalty of more than $327 million. (...)
Settling Risperdal claims could cost J&J $1 billion - WSJ
pharmatimes.com 13.5.2011
The Wall Street Journal is reporting that prosecutors in the USA are seeking some $1 billion from Johnson & Johnson to settle alleged claims of illegal marketing of the firm's antipsychotic blockbuster Risperdal.
The healthcare giant's previous marketing practices for Risperdal (risperidone) have been under investigation since 2004. Specifically the company was accused of claiming that the drug was safer than other antipsychotics, such as AstraZeneca's Seroquel (quetiapine) and Eli Lilly's Zyprexa (olanzapine) and of minimising the risk of diabetes associated with the treatment.
In a filing to the US Securities and Exchange Commission earlier this week, J&J noted that it had set aside an unspecified sum to settle potential civil and criminal charges. The company has since said that discussions with the US government “are ongoing and it is inappropriate to speculate”.
However, the WSJ quotes a person familiar with the situation as saying that prosecutors have been citing as a benchmark a $1.4 billion settlement that Lilly reached in 2009 to resolve a probe into its marketing of Zyprexa.
Related Links J J to appeal massive Risperdal illegal marketing award (...)
Priapism and risperidone.
South Med J. 2009 Dec;102(12):1266-8.
A patient taking oral risperidone while using cocaine and alcohol presented with priapism shortly after long-acting, injectable risperidone was prescribed. Another case of priapism was diagnosed in a sickle cell disease patient who was on oral risperidone. A penectomy due to necrosis was required in the first case, while the other patient regained erectile function. Physicians should be aware of priapism-inducing/predisposing factors, such as sickle cell disease, certain medicines or drugs of abuse, and antipsychotic medications. Risperidone is an established cause of priapism. It occurs especially in males with sickle cell disease; use of antipsychotic drugs and/or cocaine further increases risk. (...)
Risperdal (risperidone)
fda.gov/Safety/MedWatch (July 2009)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009
(...) PRECAUTIONS
Leukopenia, Neutropenia and Agranulocytosis
Class Effect: In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Risperdal. Agranulocytosis has also been reported. (...)
An unreported side effect of risperidone in children: sinus arrest with long pauses causing syncope.
Pediatr Emerg Care. 2009 Jul;25(7):465-6.
Risperidone has been reported as a well-tolerated antipsychotic in children. The most common side effects of risperidone are anxiety, headaches, insomnia, and agitation, which frequently appear with high doses. Although it is known that risperidone affects the cardiac conduction system, symptomatic bradycardia has not been reported previously in children. We report a child who developed syncope because of sinus arrest with long pauses (>3 seconds) with therapeutic doses of risperidone. This case suggests that close monitoring is mandatory even during therapeutic treatment with risperidone. (...)
Alkermes rises on Risperdal Consta forecast
forbes.com 21.12.2008 (Associated Press)
Shares of Alkermes Inc. rose Friday after a Jefferies & Co. analyst upgraded the stock, saying its anti-psychotic Risperdal Consta may be better than potential rival drugs.
Analyst David Windley raised his rating on Alkermes shares to "Buy" from "Hold," saying Risperdal Consta sales should remain strong even if competing drug candidates from Johnson & Johnson and Eli Lilly and Co. are approved for sale. He set a price target of $15 per share, and said the stock is inexpensive. (...)
"The company has reliable revenue from Risperdal Consta sales that should last for many years," he wrote. He estimated sales will exceed $1.3 billion in 2008, of which Alkermes will get about 10 percent.
Alkermes expects $200 million to $225 million in revenue in fiscal 2009, while analysts are looking for $252.3 million, according to Thomson Reuters. The period ends in March 2009. (...)
Some drugs risky for seniors, FDA says (Noen legemidler er risikable for eldre, ifølge FDA)
seattletimes.nwsource.com 17.6.2008
The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia... (...)
The FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly's Zyprexa and Johnson & Johnson's Risperdal.
FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side effects, such as tremors. (...)
Risperidone (Risperdal) Gets FDA Nod for Schizophrenia and Bipolar Disorder in Kids
medpagetoday.com 22.8.2007
ROCKVILLE, Md., Aug. 22 -- The FDA approved risperidone (Risperdal) today for schizophrenia in adolescents and for bipolar I disorder in pediatric patients as young as 10.
The action marks the first time that the FDA has approved an atypical antipsychotic medication for use in children, said Thomas Laughren, M.D., director of the division of psychiatry products at the FDA's Center for Drug Evaluation and Research. (...)
As in adults, risperidone was associated with weight gain in children and it also increased prolactin levels by about 49%, which makes gynecomastia a consideration said Dr. Laughren. (...)
Butter Up Docs With Risperdal Popcorn
pharmalot.com 21.5.2007
Are those free lunches from sales reps becoming gauche? Are too many docs too busy to have time for a real lunch, anyway? Why not give them something quick and tasty then? Something that isn't quite a meal, but isn't junk food either?
Johnson & Johnson has come up with an answer: Risperdal popcorn.
Easy to cook, lasts for hours and it doesn't even contain active drug ingredients. (...)
Psychiatrists, Children and Drug Industry’s Role (Psykiatri, barn og legemiddelindustriens rolle)
nytimes.com 10.5.2007
Psychiatrists, Children and Drug Industry’s Role
When Anya Bailey developed an eating disorder after her 12th birthday, her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal.
Anya Bailey has a painful nerve condition called dystonia, in which the muscles in her back clench as a result of taking an antipsychotic drug. (...)
Just as surprising, Ms. Bailey said, was learning that the university psychiatrist who supervised Anya’s care received more than $7,000 from 2003 to 2004 from Johnson & Johnson, Risperdal’s maker, in return for lectures about one of the company’s drugs.
Doctors, including Anya Bailey’s, maintain that payments from drug companies do not influence what they prescribe for patients.
But the intersection of money and medicine, and its effect on the well-being of patients, has become one of the most contentious issues in health care. Nowhere is that more true than in psychiatry, where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics.
These best-selling drugs, including Risperdal, Seroquel, Zyprexa, Abilify and Geodon, are now being prescribed to more than half a million children in the United States to help parents deal with behavior problems despite profound risks and almost no approved uses for minors.
A New York Times analysis of records in Minnesota, the only state that requires public reports of all drug company marketing payments to doctors, provides rare documentation of how financial relationships between doctors and drug makers correspond to the growing use of atypicals in children.
From 2000 to 2005, drug maker payments to Minnesota psychiatrists rose more than sixfold, to $1.6 million. During those same years, prescriptions of antipsychotics for children in Minnesota’s Medicaid program rose more than ninefold. (...)
(Anm: dystonia; dystoni; endring i muskulaturens spenningstilstand, ofte i form av ufrivillige muskelsammentrekninger (f.eks. i nakkemuskulaturen og svelgmuskulaturen. Dystoni kan være symptom ved indremedisinske og nevrologiske sykdommer, men kan også opptre som bivirkning av legemidler som blokkerer signalsubstansen dopamin. Akutte dystonier sees hos yngre menn noen dager etter at vedkommende har begynt på relativt høye doser med nevroleptika. (...) Ved akutte dystonier på grunn av legemidler er behandlingen tilførsel av antiparkinsonmidler. Kilde: Store norske leksikon.)
Not all sold on pill for autism (Ikke alle kjøper argumentet om piller mot autisme)
latimes.com 20.11.2006
Advocacy groups say the side effects of federally approved Risperdal, which includes weight gain, outweigh the benefits.
For the first time, the Food and Drug Administration has approved a drug to treat behaviors such as aggression, deliberate self-injury and severe temper tantrums associated with autism in children.
Risperdal, an anti-psychotic drug, was approved last month to treat symptoms in children and adolescents ages 5 to 16. (...)
Some doctors warn that the drug should be used only after other treatments are tried that don't involve medication. And the National Autism Assn., an advocacy group for families of autistic children, has serious concerns about Risperdal. (...)
But this particular drug appears to have some very serious side effects. It's a nightmare," said Rita Shreffler, executive director of the association. (...)
Risperdal will do nothing to eliminate the underlying condition, doctors say. (...)
FDA approves drug for autism symptoms in children
usatoday.com 6.10.2006
— A Johnson & Johnson drug received expanded federal approval Friday to treat aggression and other symptoms of autism in children.
The new use for Risperdal is to treat irritability associated with autistic disorder, including temper tantrums, deliberate self-injury and aggression in children and adolescents, ages 5 to 16.
The approval is the first for the use of a drug to treat behaviors associated with autism in children, the Food and Drug Administration said.
Risperdal, first approved by the FDA in 1993, has been used to treat schizophrenia and bipolar disorder in adults. (...)
In 2005, the FDA declined to expand its approval of Risperdal, also known as risperidone, to include autism. (...)
Government widens probes of antipsychotic Risperdal
fiercebiotech.com 15.3.2006
Johnson & Johnson has acknowledged that government probes into the sales and marketing of its antipsychotic drug Risperdal have been expanding. Risperdal was J&J's biggest seller last year, bringing in $3.55 billion. Investigators have been demanding internal corporate documents, including records of payments to doctors.
- read this Wall Street Journal report (sub. req.)
Maker of drug admits hiding its risks
The Miami Herald 24.7.2005
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.
Patient Information Sheet
Risperidone Tablets (marketed as Risperdal)
FDA ALERT [04/2005] - Risperdal is a type of medicine called an atypical antipsychotic. FDA has found that older patients treated with atypical antipsychotics for dementia had a higher chance for death than patients who did not take the medicine. This is not an approved use.
FDA has asked the companies that make these medicines to change their labels to include this important information. (...)
2004 Safety Alert: Risperdal (risperidone)
fda.gov (August 4, 2004)
The following information is from Janssen Pharmaceutica, Inc. Contact the company for a copy of any referenced enclosures. (...)
WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including Risperdal. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. (...)
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