My Objection to a New 2-Week Injectable Version of Zyprexa (an NDA with the FDA)

If you see the open letter to Mothering Magazine below, I stated that I did not believe that Thomas Hale would recommend antipsychotic drugs during breastfeeding. I was wrong. Based on a 2003 study of 7 women, 6 of whom were "evaluable," the entire world now is subject to the irresponsible recommendation to use Zyprexa while breastfeeding. Lilly wants more patent protection for Zyprexa so they are proposing a new injectable formulation that is a 2-week long-lasting shot. Please read my letter to the FDA below and send your objection letter to the email address or fax number provided here.

This written testimony is being submitted to the FDA for the Feb. 6 Zyprexa hearing on concerns about increased somnolence with the new formulation.You have until January 18 to submit your written testimony to:
Diem-Kieu H. Ngo, Pharm.D., BCPS LCDR, U.S. Public Health Service Program Management Officer Food and Drug Administration Office of Executive Programs Advisors and Consultants Staff (HFD-21) 5630 Fishers Lane Room 1093, Rockville MD, 20857 Telephone: 301-827-6765 Fax: 301-827-6778 diem.ngo@fda.hhs.gov
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I submit this testimony as an extreme objection to possible approval of any NDAs for new formulations of the highly dangerous drug Zyprexa, and particularly to the proposed intramuscular, extended-release, long-acting (2 week) version. A 2-week-long extended-release formulation which could potentially threaten children who are incapable of efficiently metabolizing it (such as breastfeeding infants), and which carries increased somnolence effects compared to older formulations, will inevitably lead to "SIDS" in some infants if the drug is allowed to be given to breastfeeding women. Should this occur, increased cases of depression in mothers who lose their infants because of drugs will increase subsequent profits for Eli Lilly through additional sales and continued drugging of grieving mothers and families.
For the sake of expediency I'll assume you understand that psychosis is commonly caused in postpartum women by administration of SSRIs. (I know that it is, because I survived the dose-dependent worsening of homicidal and suicidal urges and even one hallucination which started after only 3 days on Zoloft. My family and I suffered through for about 5 months - starting with Zoloft samples at 6 days postpartum following the birth and near death of my son in July 2004, and continuing through months of frightening urges, expensive hospital bills and visits to psychiatrists and therapists, my condition worsening to the point of near loss of control over my own thoughts or actions until I discontinued the drug. I also know this from the research that I have read over the past 3 years.) I believe that the push to medicate mothers with antipsychotic drugs serves more than the purpose of attempting to control psychosis, bipolar disorder, or extreme depression (which Zyprexa does not do - recent studies undertaken on "antipsychotic" drugs have revealed that patients on placebo actually improved more than those taking atypical antipsychotics, like Zyprexa).
Even if Zyprexa were discontinued by someone who tried it, in favor of a lesser poison, an SSRI would only lead people back to a place where they feel they cannot function without antipsychotic drugs. And so the cycle of sacrifice on the altar of profit and power will continue... Among the effects produced by Zyprexa (and there are almost 3,000 known side effects), somnolence seems to be the most advantageous to the psychiatric staff who will be dealing with patients. With or without breastfeeding mothers' use, a long-lasting extended-release version which increases somnolence beyond what these major tranquilizers already do will make the task of filling beds and subduing psychiatric patients much easier and more profitable. And it will pose a serious threat to young children whose parents and doctors are quick to medicate them for the "symptoms" which are nothing more than the effects of other toxic drugs and foods - things that your organization should never have allowed to be legally fed to and injected into children.
The current cost of atypical antipsychotics is $300-$600 more per month than older antipsychotic agents and sales are steadily increasing. This is Eli Lilly's best-selling drug, and with all the new users of SSRIs and other psychosis-inducing, FDA-approved drugs, it is likely to remain a profitable drug as long as it enjoys FDA approval, patent protection and inadequate warnings, and even potentially bring in huge sales as a generic drug.Even though Zyprexa has not been studied in under 18s, I can tell you that every day parents feed their children antipsychotic drugs like Zyprexa because of court orders. Why in a country supposedly regulated by your agency is this allowed to happen? This is criminal! If you do approve the new intramuscular version of Zyprexa extended-release I hope you will do the right thing and create requirements for this drug to be severely controlled. It should be illegal for a psychiatrist to force-drug a child with this medication or any medication which causes permanent neurological damage and tics. It should be illegal for a pregnant or breastfeeding mother to take it.
According to the package label for current formulations, intramuscular administration of Zyprexa results in a plasma level 5 times that of oral dosage tablets and reaches that concentration within 15-45 minutes, compared to 6 hours for the oral version. What will be the speed and exposure level of a longer-acting version? In addition, the somnolence effect is more pronounced in current intramuscular versions compared to oral tablets, and it is reported to be worse in the newer version for which Lilly seeks the patent.
And what are intramuscular injections used for? Most commonly they are used in cases of forced treatment for hospitalized patients. Given the fact that almost every patient who enters a psych ward will be given an antipsychotic agent, the potential for worsened adverse events is profound. The situation which we are faced with is one where the order of a doctor - even one who has never met the patient - but is told of her situation over the phone - can legally require a patient to be locked up, deprived of informed consent, and force-drugged with poisons approved by your organization. So I ask, are you the FDA, charged with regulating drugs and foods that the public faithfully trusts are safe or "safe enough," or are you merely a tool drug companies use to persuade the public to trust in their so-called science, proprietary and twisted as it may be?

The label for Zyprexa includes a warning against nursing an infant while taking the medication. However, recently Dr. Thomas Hale and Kathleen Kendall-Tackett (among others) have encouraged breastfeeding mothers who experience psychotic episodes to make their way immediately to a hospital and get treatment with Zyprexa without interrupting breastfeeding. According to Mothering Magazine, psychotic breastfeeding mothers can safely continue nursing while taking Zyprexa if they avoid feeding during peak plasma concentration.
What is the likelihood that a doctor will know when the peak concentration in a nursing mother will be, when only one study has been cited by advocates of this position as an excuse for evidence of safety, and this was conducted on a sample with 7 women? Most breastfeeding studies have samples this small, even for drugs like Zoloft, with samples as small as 4 women, and totaling around 30 women in all. In addition, many studies purporting to study breastfeeding women have actually involved mostly women who were not exclusively breastfeeding, with the infant who was exclusively breastfed being the one who experienced seizures and coma and other serious effects.
Not to mention that psychiatric patients are often given multiple drugs which cause concentrations of Zyprexa to become elevated and increase the somnolence effect. The Zyprexa package label also cites reports of pregnant women using Zyprexa which led to 1 neonatal death, 3 therapeutic abortions, and 1 spontaneous abortion (or miscarriage). Though the package label states that infant exposure through breast milk is as high as 1.8% of the maternal dose, the article cited by Thomas Hale in his recommendations that Olanzapine is an acceptable drug for breastfeeding mothers claims that out of the six "evaluable" samples... the exposure was only 1% of the maternal dose. They only studied 7 people, 6 of whom were "evaluable", yet on this weak basis the drug is recommended to breastfeeding mothers for psychosis, bipolar disorder and extreme depression.
How can we in good conscience expose infants to risks like excessive somnolence, hypotension, seizures, tardive dyskinesia and multiple other effects? This drug has not been studied or approved for children under 18, yet it is now being prescribed to breastfeeding mothers and apparently some pregnant mothers as well.
This is completely irresponsible, and even though the advice of breastfeeding advocates differs from what the package inserts say (as to the the level of exposure to the baby, the claims of no side effects in babies, and in the attitude about the reasoning behind the claims being based on liability versus risk), people are currently going along in droves with the most dangerous advice, rather than heeding the most cautious approach.
How is a mother who is under the influence of a drug which causes extreme somnolence supposed to prevent the baby from nursing at peak concentration times? Anyone who has ever seen a patient under the influence of antipsychotic agents knows that the other profound effects of Zyprexa can incapacitate you to the point that you would not even be able to care for yourself, much less an infant. A drooling, barely able to walk or talk woman, whose bodily functions have been disrupted cannot be expected to do anything to take care of a baby safely, and the expectation that she would is dangerous. If any woman taking the drug actually were able to continue caring for her baby she would at minimum be severely impaired. Perhaps she could lie around nursing her child 24 hours a day and increase the exposure, but it is doubtful she could do much more.
A mother who is told to take Zyprexa while nursing cannot be expected to manage breastfeeding in a way that would minimize exposure at a peak concentration time, particularly if she is also taking another agent like Prozac which enhances plasma levels of olanzapine. If concomitant medications or intramuscular injection are used, the concentration multiplies 5 times or more, and could reach peak concentration in a shorter amount of time (according to the package label, 15-45 minutes from intramuscular injection alone and potentially faster if mixed with other drugs). How is a mother supposed to guess how all the factors play a role? Furthermore, Zyprexa increases prolactin levels and will thus increase milk supply and overall exposure for the baby (especially by increasing the likelihood of engorgement and mastitis, thereby encouraging the mother to nurse more frequently, especially during potentially peak concentration times).
Most women who would be so insistent on nursing as to continue doing so while taking this medication would be those who are also co-sleeping and night nursing. Increased somnolence above and beyond current levels caused by existing formulations, in this type of co-sleeping situation, would be even more dangerous than somnolence in other patients due to the lack of the awareness of the baby's whereabouts and the potential for a mother to fail to notice whether her baby is nursing when a potentially peak concentration time is taking place. Is increased bonding worth the risk that these drugs pose to infants? Somnolence, seizures, coma, inability to regulate temperature, all effects of Zyprexa... these pose so much risk to babies for SIDS that it sounds like population control or eugenics to recommend them. Even if all psychotic mothers and their babies were accidentally killed by drugs we will still have more come along because of SSRIs and other FDA-approved drugs.
Infants cannot metabolize drugs at the same rate as adults - drugs are more readily absorbed, more free-floating drug courses through their veins, their kidneys work at 30-40% the capacity of adults, and brain concentrations are always higher than the dose would suggest (10 to 30 times higher) due to the immature blood-brain barrier. It takes infants much longer to rid themselves of a single dose. How long will it take an infant exposed to Zyprexa to eliminate it - especially if the child is a newborn? If the toxic effects are noted in an infant who is exposed to an even longer-lasting formulation (such as a 2-week formulation), it will already be too late to do anything to save the child. Prozac has caused coma in infants exposed through mother's milk... why would we put them at risk with a drug much more toxic?
Involuntary injection with a formulation of a highly dangerous drug which will not wear off for 2 weeks will pose a particularly serious threat in any case of a breastfeeding mother who comes to the hospital for psychosis. It is not unreasonable to assume that psychiatric staff may at some point inject a woman with this prior to learning that a mother is breastfeeding, nor is it unlikely that the mother may insist on the basis of Hale's endorsement that she can continue nursing her baby on this drug. If this is allowed, there is no doubt that mothers who start the treatment will probably continue an oral version if they are sent home. If the drug were to be banned to breastfeeding women (a burdensome choice you could easily enact by declaration due to safety concerns), then any mother mistakenly forcibly injected with this drug will also be forced to discontinue breastfeeding, most likely permanently.
If the FDA approves the New Drug Application and hands Eli Lilly another several years of patent protection in a market that has grown to over 4 billion dollars per year and is ever-expanding, we will have a dire situation on our hands.
Doctors do not abide by your recommendations, or even necessarily those of drug companies, and currently even though the package insert says that pregnant and breastfeeding women should not use Zyprexa - or women who use it should not breastfeed, this advice is not being heeded. Three years ago I was told that I should wean my baby and take Zyprexa - that the "symptoms" I was having stood a better chance of relief with a toxic drug that my baby could not have. I chose not to go on Zyprexa or wean my son. Instead I eventually realized that no matter how long I gave Zoloft to work, it was only going to make me more homicidal. I was even told it was not Zoloft, but that I was just crazy, and ought never to have more children. But I got off Zoloft and as a result I got better. I had a second child (an un-interfered-with home birth attended by a CNM), and experienced no PPD whatsoever in the past 16 months since my second son was born.
Psychiatrists have demonstrated no concern for safety whatsoever, even prescribing cocktails of drugs to very young children for completely ridiculous reasons despite the evidence that children can die from being given these medications (not to mention that adults can too).
You go after chiropractors or doctors who administer unapproved hormone treatments, sandwich carts that serve tainted food, and vaccine manufacturers who put contaminated drugs into vials intended for injection into newborns, and you should equally go after judges who court-order parents to drug their children, psychiatrists who prescribe these drugs and others in a cocktail, and any hospital that force-treats someone with harmful medications. There should be some sort of improved warning or prescription process that applies to Zyprexa and the entire class of drugs so that mothers will not be led astray and into dangerous territory by people who haphazardly attempt to be their advocates.

We have entered a brave new world where drug companies seek FDA approval for new versions of old drugs for financial reasons alone. Much of the public has seen how dangerous Zyprexa is, yet it remains a growing market for those who are unaware, or for those who are forced, or for those who mistakenly believe they have chemical imbalances which can only be corrected by the "right" medication. To consider approving a more dangerous version of Zyprexa simply for the financial gain of Eli Lilly, knowing that it puts patients at even greater risk is unthinkable. This drug currently costs several hundred dollars more per month than older antipsychotic agents. The very clear incentive to prescribe such an expensive drug or forcibly inject it into a patient should make you all pause and ask yourselves if you are in this organization for the ultimate mission of ensuring the safety of Americans or for keeping the drug companies profitable and powerful.

On behalf of the 257 members of CHAADA (Children and Adults Against Drugging America) and on behalf of members and friends who are unable to attend this meeting or submit written testimony due to the fact that they are currently in the midst of having their children forcibly poisoned and ruined by these drugs, I urge you to do the right thing and consider what possible implications your actions will have. The Eli Lilly corporation does not need more patent protections for a drug that is already causing so much disease in our country, especially in an even more dangerous form than the current formulation. Hopefully by the time their existing patent expires in 2011, this drug and others will already have suffered a ban, or the government will rein in their out of control actions and regulate them like a company that claims to promote health should be regulated instead of a company out for profit and more disease markets.
Your SSRI black box warning for suicide played a role in saving my life in 2004, secured my son's safety with me as his sole caregiver for the first time in his life, and made it possible for me to go on to have another child. The public has been deluded for too long and it is your responsibility to issue the types of warnings, bans, and denials of drug approval applications that will ensure public safety. We do not need more Zyprexa, more expensive Zyprexa, or more long-lasting Zyprexa. There are enough generic, less toxic drugs and placebos for doctors to experiment on us with to last us until the sun implodes or explodes, our planet is destroyed, and the solar system gets its claws on Eli Lilly and pulls it straight to Hell (unless I am mistaken and we are already living in it).

Sincerely,
Amy PhiloBreastfeeding mother of two boys
Founder, http://www.uniteforlife.org/Co-Founder, http://www.chaada.org/FOunder, http://www.babywhys.org/