Misty Posted January 18, 2009 Share Posted January 18, 2009 http://online.wsj.com/article/SB12319556108778 2025.html?mod=googlenews.wsj Patients taking the latest generation of antipsychotic drugs are twice as likely to suffer sudden cardiac failure and death as nonusers, according to a new study that found such medicines are no safer than the older ones they have largely replaced. Though the health risks of antipsychotic drugs for elderly patients have been previously documented, the study, published in this week's New England Journal of Medicine, was one of the largest to date, and it found dangers for younger adults, too. Drug Warning A medical study adds to doubts about the safety of newer antipsychotic drugs. So-called atypical antipsychotics were found to be no safer than the drugs they replaced.Both older and newer antipsychotics doubled the rate of sudden cardiac death in patients studied.The risk of death increased for patients receiving larger doses of antipsychotics. The study's findings add to a growing body of research questioning the safety, cost and effectiveness of so-called atypical antipsychotic drugs. In 2007, U.S. sales of all antipsychotic drugs were $13.23 billion, up 12% from $11.81 billion in 2006, according to IMS Health Inc., a health-care information and consulting company. Atypical drugs were the driving force behind that growth; such medications had U.S. sales of about $13 billion through the first 11 months of 2008. The atypical drugs used in the study were Seroquel, made by AstraZeneca PLC; Zyprexa, made by Eli Lilly & Co.; Risperdal, made by Johnson & Johnson; and Clozaril, made by Novartis AG. The "typical" drugs used for comparison were haloperidol and thioridazine, both generics. An editorial accompanying the new study said the use of such drugs should be "reduced sharply" among children and elderly patients. Jerry Avorn, a professor of medicine at the Harvard Medical School and co-author of the editorial, said atypical antipsychotic drugs have been marketed as a safer alternative to older, more conventional medicines. "Now we understand that they have their own problems that are quite substantial, " said Dr. Avorn, who was not involved with the study. The growing use of such drugs has sparked widespread debate in the medical world. In November, a panel of outside advisers urged the Food and Drug Administration to discourage doctors from prescribing atypical antipsychotic drugs for children. Meanwhile, Connecticut, Arkansas and other states have sued various drug makers, alleging that they marketed such drugs for uses not authorized by the FDA and didn't adequately disclose potential side effects, such as weight gain and diabetes. The FDA approves drugs for specific uses. Doctors can prescribe them for other treatments, but drug makers can't promote them for unapproved uses. Conventional, or typical, antipsychotic drugs like chlorpromazine, known by the brand name Thorazine, have been used to treat conditions such as schizophrenia since the 1950s. But their side effects include involuntary tremors and tics that are sometimes irreversible. Studies have also linked them to sudden cardiac death, an abrupt and unexpected loss of heart function. First introduced in 1989, the atypical drugs caused fewer of the involuntary- movement problems. Researchers say they were also thought to be much safer. But in recent years, that view has come into question. Black-Box Warnings After reviewing various studies, the FDA in 2005 began requiring makers of atypical drugs to put a so-called "black-box" warning on labels to indicate that elderly patients with dementia taking such drugs had a higher risk of premature death. The FDA hasn't approved the use of such drugs by dementia patients. The studies reviewed indicated the deaths were primarily related to heart-related causes and infections. Last year, the agency began requiring a similar black- box warning for older, typical antipsychotic drugs. A small study published this month in Lancet Neurology, a British medical journal, found that the long-term use of any antipsychotic medication by 165 Alzheimer's- disease patients doubled their death rate after one year. In 2006, a large federally funded study into the treatment of schizophrenia found that the heavily promoted atypical drugs were no more effective than the old ones and cost up to 30% more. While FDA authorizations vary by drug, atypical drugs are approved for treating schizophrenia, bipolar disorder and irritability associated with autism in children as young as 5. Researchers say they are widely prescribed for off-label treatment of dementia in nursing-home patients and attention deficit hyperactivity disorder, or ADHD, in children. For the new study, researchers at Vanderbilt University in Nashville, Tenn., reviewed the medical records of about 277,000 Tennessee Medicaid enrollees for the years 1990 to 2005. Of them, about 46,000 were taking atypical antipsychotic drugs and 44,000 were taking typical antipsychotic drugs. About 187,000 weren't taking any of the drugs. Patients ranged in age from 30 to 74 years; the average age was about 46. Researchers said that among patients taking the antipsychotic drugs, there were about three sudden cardiac deaths for every 1,000 patient- years included in the study. A patient-year is one patient taking the medication for one year. Although patients taking atypical drugs had a slightly higher death rate than those taking the older medicines, researchers said the difference was not statistically significant. The death rate was about half that level for the control group of patients who weren't taking any antipsychotics, the study said. The study also found that the risk of death increased for patients receiving larger doses of both kinds of drugs. "It suggests that the drugs, when used, should be used at the lowest possible dose," said Wayne Ray, the lead investigator. Dr. Ray, a professor of preventive medicine at Vanderbilt University, said he believes the study will affect the practice of medicine and prompt physicians to be as careful about prescribing the atypical drugs as they are about using the problematic older typical medications. "The thinking that these atypical drugs were free of risk of sudden cardiac death seems to be incorrect," he said. An Eli Lilly spokesman said the study provides information physicians should consider when prescribing such drugs but added that Zyprexa has helped millions with serious mental illnesses regain control of their lives. A J&J spokesman said the study "adds important new information" to related research and that atypical drugs offer "significant benefits" to many patients with severe and debilitating symptoms. Patient Safety Novartis said it places the highest priority on patient safety and is evaluating the study's findings. An AstraZeneca spokesman said the company believes Seroquel is safe and effective but won't comment on the study until it has reviewed it in detail. In a disclosure published with the study, Dr. Ray said he has received research support from Pfizer Inc., manufacturer of a competing atypical antipsychotic drug called Geodon. He has also received consulting fees from plaintiffs lawyers in litigation involving other sorts of drugs. C. Michael Stein, a co-author and fellow Vanderbilt researcher, disclosed that he has received consulting fees from insurance companies regarding antipsychotic drugs. Write to Robert Tomsho at rob.tomsho@wsj. com Quote Link to comment Share on other sites More sharing options...
chiguirre Posted January 18, 2009 Share Posted January 18, 2009 My pediatric neurologist is very paranoid about Risperdal and weight gain and has been since ds started it 4 years ago. My impression was that it had a bad reputation for side effects and that doctors only prescribed it as a last resort. OTOH, it's one of the only drugs that reduces aggression in autistic children. Given the choice of lowering aggression to a survivable level or having to place your child in a state home, the side effects don't look that bad. Quote Link to comment Share on other sites More sharing options...
Ottakee Posted January 19, 2009 Share Posted January 19, 2009 You can have the doctor order an EKG and even an ultrasound of the heart to help you greatly reduce the risks. If something abnormal comes up, then you can address that. Our pdoc said that with some of the meds, it was not the med CAUSING it but rather the child/adult already had a heart problem, they just didn't know about it before starting the meds. There are risks and benefits to all things but like others have said, at times the risks are really minimal if the med can give your child a more normal life and allow them to stay at home. Quote Link to comment Share on other sites More sharing options...
Rhonda in TX Posted January 19, 2009 Share Posted January 19, 2009 It's an adult medication, not officially tested or approved for children. I'm sure it does help children, but parents need to be aware of all the possible side effects before making the decision. They wanted to put my DS on Risperdal when he was 6 years old. We chose not to do it and he's not anywhere close to needing to be in a state home. They don't always prescribe it as a "last resort". Quote Link to comment Share on other sites More sharing options...
Pamela H in Texas Posted January 20, 2009 Share Posted January 20, 2009 There are issues with most of these meds. Like Christina said, the choice isn't pretty. Last year, a guy I was in the phosp with died right after starting Seroquel. I had actually, in the hosp, had an issue with Abilify then Seroquel. It was so bad that I ended up leaving the hospital early (which it had been 10 days already, but I wasn't on meds that would work for me). My son was on risperdal at 8. He went from a skinny little thing to overweight in ONE month. He's been fighting weight since though he hasn't been on the med in 5 years. It obviously changed something in him. But like Christina said, what is a parent to do. We'd rather NOT pump these drugs into our kids, but sometimes it's necessary for a time or long term. My ds, like me, is extremely sensitive to medication (and other stuff too). We never found a good situation for him, but used meds in times of crisis (and would again if we had to). I needed them for most of the past 15months, but have done well without them for a couple months now. It's just how it is unfortunately. Quote Link to comment Share on other sites More sharing options...
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