Risperdal may not be as safe as once thought...

[Misty]

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

[chiguirre]

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.

[Ottakee]

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.

[Rhonda in TX]

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".

[Pamela H in Texas]

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.