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What To Do With A Risky Drug- Give It To Kids

Posted by Jane Akre
Saturday, December 22, 2007 8:39 PM EST
Category: Major Medical, Protecting Your Family
Tags: Defective Drugs, Zyprexa, Olanzapine, Antidepressants and Other Psychiatric Drugs

 

Zyprexa may be given the FDA okay for use in teens and adolescents even though it has severe side effects for some adults.

 

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It sounds like a bad joke.

Zyprexa is an antipsychotic drug effectively given to treat millions of adults with schizophrenia and bipolar disorder. 

Among a second generation of antipsychotics, Zyprexa was an  “atypical” antipsychotic wonder drug developed in the 1990’s and thought to be a silver bullet in the battle against severe mental illness because it didn’t cause the tremors and facial tics of other drugs.   

Atypical antipsychotics were more expensive but much heralded and with an intense marketing campaign, Zyprexa and other atypicals were increasingly prescribed by doctors for all sorts of mental health issues including “off label” to treat depression and anxiety.

But there were the downsides. Zyprexa caused serious weight gain and diabetes among patients who had no history of diabetes before taking it. 

Internal Eli Lilly documents showed that 16 percent of patients on Zyprexa gained more than 66 pounds after taking the drug for a year, a figure higher than what Lilly revealed publicly. 

In a St. Petersburg Times article, a sales rep says he was told to tell doctors that patients should drink a glass of water before they eat to suppress appetite to fight the weight gain.

The reps pitch was “Would you rather have a skinny, unwell patient or a fat, stable one?”

Ultimately some 30,000 patients sued the maker for these undisclosed side effects and Eli Lilly paid out more than $1-billion to settle the cases.

If you think that should be the end of the story you’d be wrong.

Eli Lilly has an application pending for approval of Zyprexa for adolescents and the FDA is poised to give the okay.

FDA Doc Overturns Experts

Lilly brought a six-week study of 107 teens with schizophrenia to the FDA as the basis for approval.  Half of the teens were Russian.

But a three person expert advisory panel voted to deny approval for its use in adolescents based on insufficient data from those studies.

The reviewers were also concerned about the overwhelming positive responses among Russian patients and whether that might indicate fraud.  The FDA found no evidence of fraud and the expert’s advice was overruled by the head of psychiatric drugs at the FDA.

In an April memo, Dr. Thomas Laughren of the FDA’s Division of Psychiatric Products wrote that the benefits of the drug outweigh the concerns. (His memo had to be released under a 2002 rule that requires the FDA to release summaries for pediatric use applications.)

Laughren concluded Zyprexa is effective and safe for treating children with schizophrenia and bipolar disorder.  

Child Effects

Side effects in children include weight gain, sedation, fatigue and dry mouth - similar to what is seen in adults however “with some differences in magnitude” according to Laughren. 

Kids on Zyprexa are reported to be always hungry and look puffy. Competitors told doctors that Zyprexa’s generic name, olanzapine, should be called “olanza-pig.”  Some kids have reportedly gained 50 pounds on the drug.

Dr. Laughren believes that “These differences will need to be reflected in labeling.”

Another atypical antipsychotic, Johnson and Johnson’s Risperdal is the only one cleared by the FDA for use in children ages nine and older. 

But Zyprexa is frequently given “off label” to children and teens to treat everything from behavioral problems including aggression and defiance to bipolar disorders. It is difficult to identify bipolar disorder or schizophrenia in adolescents as the symptoms can mimic depression or ADHD.

A St. Petersburg Times investigation finds in Florida children prescribed antipsychotics has increased some 250 percent over the last seven years. Children as young as three were included in the investigation. There have been no long term studies on the drugs’ affect on the brain.

The USA Today study finds that outpatient prescriptions for 2 to 18 year olds increased fivefold from 1995 to 2002 to about 2.5 million prescriptions. That is a rate growing dramatically faster than adult prescriptions. 

Dr. David Healy a psychiatrist at the University of Wales says Zyprexa should be used as a last resort for adults and “it ought not to be used in children at all. It is going to be marketed as a safe and gentle drug, It is not a safe and gentle drug. I think it’s an extremely dangerous drug. The idea that it’s going to be given to children on a large scale is quite scary.”

A USA Today study of FDA data found that among 45 deaths among children where atypical antipsychotics were listed as the “primary suspect” at least six were related to diabetes.  Many of the children were on a multitude of drugs. The youngest in the group was taking ten other drugs. 

St. Petersburg, Florida attorney Joe Saunders has eight Zyprexa clients but still believes the drug may be helpful if properly monitored.  “The fear is that based on its past history it’s a market grab” he tells IB News.

The litigation is not over for Zyprexa.  A number of states are suing Lilly and other antipsychotic makers over aggressive advertising that downplayed the side effects. The states want to be reimbursed for Medicaid payouts in the hundreds of millions of dollars. 

With fewer doctors writing prescriptions, sales for Zyprexa have been slipping from its high of $4.4 billion last year for Lilly’s biggest seller.   

Lilly receives six extra months of protection under its patent which is set to expire in 2011 because of its pediatric studies.   That amounts to an extra $1 billion in revenue according to estimates.

AstraZeneca is reportedly testing Seroquel in youngsters and may also apply for FDA approval.    #

 

 


5 Comments

Anonymous User
Posted by Anon
Sunday, December 23, 2007 11:57 AM EST

I have observed Dr. Laughren during FDA Public Hearings. He looks down, bored, waiting for them to be over as distraught parents and spouses tell of the death of their loved ones and beg the FDA to take a psychotropic drug off the market or strengthen the warning on the label.

This is the same situation. Despite myriad deaths from this most lethal atypical antipsychotic, Laughren is unmoved. Despite the 100% denial for approval of the Advisory Panel, based on the flimsiest of clinical trials, Laughren is unmoved.

Having lost my child to this drug, this move is probably my worst nightmare. Though children have died from it when given it off-label, I fear approval will open the floodgates that much wider. And after a huge settlement such as the previous Zyprexa settlement, Lilly will move on to trade the drug in other, more unsuspecting countries. It pays to have George Bush as your friend.

Anonymous User
Posted by Jane Akre
Wednesday, December 26, 2007 9:39 PM EST

I'm very sorry for your loss.

Thank you for sharing your observations of Dr Laughren.

In doing research for this story I was shocked by the number of people who turn to drugs for a first line of defense without even trying some of the basics that might help restore health.

The number of children on multiple drugs is shocking.

Posted by Ben Hansen
Thursday, January 03, 2008 9:53 AM EST

Between 2004 and 2006 the FDA MedWatch program received 7,320 Individual Safety Reports naming Zyprexa the Primary Suspect Drug for 2,962 distinct adverse reactions.

See the full list of Zyprexa side effects here:
LINK

It's a pretty impressive list!

Posted by C Lawrence
Thursday, January 03, 2008 10:45 PM EST

Jane...thank you so much for this article. I hope it is ok to pass it along to others concerned with children. I'm appalled that so many adults are being prescribed these drugs, let alone children!

C. Lawrence

Anonymous User
Posted by J. Akre
Tuesday, January 08, 2008 9:58 PM EST

The story I posted today about our health care bill being $2 trillion for 2006 with the largest segment going for drugs. Yet at the same time among 20 industrialized nations, the U.S. has the lowest ranking ie the most deaths in the preventable death category.
Perhaps the drugs we are taking are not prolonging our lives? It's good to see the new year with such enthusiasm about health- let's remember all of this enthusiasm in July!!! There are so many good web sites with information on how people can take control of their health. Perhaps that's easy to say if you are basically a healthy person. If you are sickly, you likely have had a good experience with prescription drugs.

Thanks for writing.

Comments for this article are closed.

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