Lawsuits filed over drug side effects

A Philadelphia law firm today said it filed 10 lawsuits on behalf of boys and young men who developed serious side effects - including the growth of breasts - while taking the antipsychotic medications Risperdal and Invega.

The suits were filed in Philadelphia Court of Common Pleas. Lawyer Stephen Sheller said he expected to file an additional 20 to 30 similar cases in Philadelphia in the next two months. His firm also has 10 cases involving boys who took Risperdal and another medication pending in New Jersey.

The drugs in the Philadelphia cases are made by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc., which is part of Johnson & Johnson. All of the companies, which are named in the suits, are based in New Jersey, but Ortho-McNeil-Janssen is incorporated in Pennsylvania, Sheller said.

Only one of the plaintiffs, a young man who took Risperdal in his teens, is from Philadelphia. He could not be reached for comment. The suit says he experienced rapid weight gain and developed breasts that will require surgical removal. The side effects caused him to suffer "mental anguish" and "embarrassment," the suit said.

Sheller said some of his already-troubled clients grew significant bosoms, a fact their doctors may not have taken seriously enough because of the weight gain. "I would say 38D, some of them," Sheller said. "No boy wants to have a B cup, certainly not a D."

Janssen declined to comment. "We have not received details of the cases and are therefore unable to comment at this time," spokeswoman Kara Russell said.

The suits also named Excerpta Medica Inc., of Bridgewater, N.J., and its parent, Elsevier Science Publishing Co. Inc., of New York. Sheller said the companies were involved in publishing ghostwritten studies they should have known were misleading or exaggerated. An Elsevier spokesman said the company had not had time to evaluate the suits.

READ MORE @ PHILADELPHIA INQUIRER

Risperdal Researcher Promised Drug Maker Positive Results from Clinical Trials

A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit involving Risperdal and other atypical antipsychotic drugs. While he is not a defendant in the case, Biederman was called as a witness to illustrate the questionable financial ties between drug makers and the research community.

Some of the 2,000 plaintiffs involved in the multi-state lawsuit are children. Risperdal wasn’t approved for use in children until 2007. However, it is known that doctors prescribed the drug off-label for thousands of children years before that. While off-label prescribing is legal, drug companies are legally barred from marketing off-label uses. But according to The Boston Globe, the companies often skirt that prohibition by paying respected “opinion leaders” - usually top experts in their field - to discuss their off-label prescribing experiences at “educational” talks or meetings.

As we reported last November, Biederman was one of those opinion leaders. Biederman has long advocated the use of atypical antipsychotics, like Risperdal, to treat children diagnosed with bipolar disorder. The lawsuit has raised questions about Biederman’s role in convincing Johnson & Johnson’s to fund a center on pediatric bipolar disorder at Harvard’s Massachusetts General Hospital.

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Use of Antipsychotics in Children Is Criticized

Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday.

More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.

But Risperdal is not approved for attention deficit problems, and its risks — which include substantial weight gain, metabolic disorders and muscular tics that can be permanent — are too profound to justify its use in treating such disorders, panel members said.

READ MORE @ NY TIMES

2.5m children on drugs in US

Antipsychotic drugs for children have taken off in the US on the back of a willingness to diagnose those with behavioural problems as having manic depression. Even children barely out of babyhood are getting a diagnosis of bipolar disorder, the modern term for the condition.

The chief symptoms are mood swings, which, however, are common in children of any age.

David Healy, an expert on bipolar disorder, said there were now 2.5 million American children on antipsychotics. However, the UK guidelines on the disorder, from the National Institute for Health and Clinical Excellence, urge caution.

One drug which prompted concern was Risperdal, originally to be sold for children with "irritability" or difficult behaviour in autism. It was reviewed by experts for the Medicines and Healthcare products Regulatory Agency because of "concern about the potential misuse of [it] as ... long-term chemical control". The drug's maker, Janssen-Cilag, though it won a licence for it, withdrew its application, citing differences with the authority.

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Lilly’s Zypreza, Pfizer’s Geodon could see reimbursement restrictions next year

Psychiatric drugs like Eli Lilly’s Zyprexa could be next on the list for reimbursement restrictions based on comparative effectiveness data, experts in the field told Pharmawire.

The move would also spell trouble for AstraZeneca’s Seroquel and Pfizer’s Geodon, two commonly prescribed and costly antipsychotics. Cost pressures will be felt most acutely starting in June, when the patent expires on Johnson & Johnson’s competing product Risperdal.

Public and private payers have been fueling the growing interest in compiling data that allows them to compare different drugs within the same therapeutic category. The information then helps shape reimbursement programs - like step therapy, where patients are required to try a cheaper drug before a more expensive one will be covered.

Tanisha Carino, a director at research firm Avalere Health and former policy analyst at the Centers for Medicare and Medicaid Services, noted that mental health is a prime target for using comparative effectiveness data to make coverage decisions.

The National Institute of Mental Health is already sponsoring the large-scale Clinical Antipsychotics Trials of Intervention Effectiveness (also known as CATIE), which have shown that older, less expensive drugs can be as effective as newer ones. The data is rife with cost effectiveness comparisons.

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US OKs J&J drug for 2 mental disorders in children

Johnson & Johnson (JNJ.N: Quote, Profile, Research) won U.S. approval to promote the drug Risperdal for treating schizophrenia and bipolar disorder in children and teenagers, officials said on Wednesday.

The prescription drug is the first medicine cleared specifically to treat schizophrenia in children, the Food and Drug Administration said.

Risperdal is already sold to treat adults with schizophrenia and bipolar disorder, as well as for irritability associated with autism in children ages 5 to 16.

Doctors have been using Risperdal and other antipsychotic medicines to treat schizophrenia and bipolar disorder, but the FDA stamp of approval will allow Johnson & Johnson to promote the drug for schizophrenic patients ages 13 to 17, and for short-term treatment of bipolar episodes in ages 10 to 17.

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Risperdal Gave Kids Tooth Decay, Depression and Drowsiness

As drugmakers seek wider approval for their antipsychotics to be prescribed for youngsters, a new study finds some docs prescribed Risperdal for children 15 years old or younger who suffered insomnia or anxiety. Meanwhile, the med caused some kids to experience drowsiness, depression, tooth decay and weight gain. The findings were part of a national study in New Zealand and published in the latest edition of Drug Safety.

More than 90 per cent of prescriptions for the 420 children involved in the study were for Risperdal, where about 600 children are regularly prescribed the drug. The study by the Intensive Medicines Monitoring Programme found harmful side effects in 30 per cent of the children on the drugs classed as “atypical antipsychotics.” A third of these were linked to the drugs, say the researchers.

Read more @ PHARMALOT

Approval of J&J's Antipsychotic Delayed for Teens

U.S. regulators delayed a request by Johnson & Johnson to expand use of its top-selling Risperdal to include schizophrenia and bipolar disorder in adolescents.

The FDA didn't request new studies on the treatment in a letter to the company, J&J said in a statement today. J&J said it would work with the agency to complete prescribing information on the drug, which is already approved for use in children with autism and adults with schizophrenia and bipolar disorder.

Use of antipsychotic drugs for younger patients has risen sharply in recent years, prompting concern among some doctors and parents about side effects including weight gain and diabetes. Risperdal, which generated $4.2 billion last year, is the second such drug delayed by U.S. regulators for teen use. Eli Lilly's Zyprexa was held up in April.

READ MORE @ REUTERS NEWS

FDA Delays Risperdal For Teenagers

Untold numbers 0f kids may be prescribed antipsychotics on an off-the-label basis every year, but the FDA held back from giving Johnson & Johnson its blessing to market the drug officially to teenagers suffering from schizophrenia.

The agency has issued an approvable letter in response to the drugmaker’s request to market Risperdal for schizophrenia in youngsters between 13 and 17, and for short-treatment of bipolar mania associated with bipolar I disorder in kids between 10 and 17. J&J was quick to note, however, that the FDA didn’t request new studies, according to its statement today.

READ MORE @ PHARMALOT

Industry’s Role in Childrens’ Antipsychotics

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.

Created for schizophrenia, Risperdal is not approved to treat eating disorders, but increased appetite is a common side effect and doctors may prescribe drugs as they see fit. Anya gained weight but within two years developed a crippling knot in her back. She now receives regular injections of Botox to unclench her back muscles. She often awakens crying in pain.

Isabella Bailey, Anya’s mother, said she had no idea that children might be especially susceptible to Risperdal’s side effects. Nor did she know that Risperdal and similar medicines were not approved at the time to treat children, or that medical trials often cited to justify the use of such drugs had as few as eight children taking the drug by the end.

READ MORE @ New York Times

Johnson n Johnson schizophrenia drug gets wider US approval

Johnson & Johnson said on Friday that U.S. health regulators have broadened the approval for its Invega antipsychotic drug as a long-term maintenance treatment for schizophrenia.

The drug, a longer-acting version of J&J’s Risperdal, was approved in December to treat acute, or short-term, schizophrenia.

READ MORE @ at Reuters