The Problems With Reglan by Evelyn Pringle

May 27, 2010

Targeting Pregnant Women

The Problems with Reglan


Although a black box warning for tardive dyskinesia was announced by the FDA in February 2009, lawsuits filed against the makers of Reglan (metoclopramide) allege the drug companies knew for decades that the risk of movement disorders was much greater than acknowledged in previous labels.

According to an expert witness report filed in a Georgia lawsuit by Dr Robert Nelson, a former 20-year employee of the FDA and National Institute of Health, “the 1/500 EPS labeling was inaccurate and misleading from the moment the oral dosage form was approved.”

In citing a 2008 study on the causes of TD at a university-based movement disorder clinic, Nelson reports that from 2000-2006, metoclopramide induced TD “was more common than any other cause, accounting for 34.5%” of all cases, or 87 out of 250.

Reglan is approved only for the short term treatment (12 weeks max) of gastroesophageal reflux disease (GERD), in adults who have not responded to other therapies, and for diabetic gastroparesis, for two to 8 weeks.

In the February 2009, letters notifying the drug makers of a need for a black box, the FDA stated, “we have become aware of continued spontaneous reports to the FDA of tardive dyskinesia associated with metoclopramide use. Exposure greater than 12 weeks was evident in a majority of these reports.”

In fact, a telephone survey conducted, by then Reglan maker (AH Robins), back in 1985, “found that 38% of Reglan users took the drug for between one and two years and another 46% of Reglan users took the drug for three to six months,” Dr Bob West, a pharmacologist and toxicoligist, says in a report filed in a Louisiana lawsuit.

Devastating Disorder

Tardive dyskinesia is one of the most devastating of all drug-induced movement disorders, according to Dr Peter Breggin, author of about twenty books, including “Medication Madness.”

“The abnormal movements or spasms can strike any of the muscles that are under voluntary control, including muscles of the face, eyes, mouth, tongue, neck, shoulders, arms, legs, hands, and feet,” he says. “Breathing, speaking, and swallowing can also be impaired.”

“Tardive dyskinesia often looks so “strange” or “bizarre” that it is mistaken for a mental illness rather than a neurological disorder,” he notes.

Reglan can also cause uncontrolled muscle spasms (dystonia), Neuroleptic Malignant Syndrome, Parkinsonism, depression, thoughts of suicide, and suicide. Common side effects include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion, and trouble sleeping, according to a June 9, 2009, FDA approved medication guide.

Pregnant Women Targeted

Four months after the black box for TD was announced, a New England Journal of Medicine study claimed that Reglan was safe for pregnant women with morning sickness.

The news of the study was sent out to all the media outlets and a massive off-label marketing campaign followed to promote the sale of Reglan to pregnant women, with journalists publishing almost identical talking points.

Reporter, Linda Johnson, put out articles through the Associated Press newswire which resulted in headlines such as, “Study Suggests Drug Is Safe For Morning Sickness,” popping up all over the internet and for major media stories for a couple weeks.

For instance, in a June 10, 2009, article that appeared in USA Today, on Fox and ABC news Websites, and even in the UK’s Guardian on June 12, 2009, Johnson wrote: “For the first time, a large study shows that pregnant women who suffer morning sickness are not risking harm to their babies if they take a certain anti-nausea drug.”

“The result may lead more doctors to prescribe the drug metoclopramide and women to feel less guilty about using it during their baby’s crucial first few months of development, experts said,” she reported. Johnson never mentioned the black box for TD in her articles.

The June 10, headline for the same article on the MSNBC Website read: “Morning sickness drug shown safe for babies.” On June 11, a Johnson article appeared in the Boston Globe and the same story was in the Durango Herald News as late as June 22.

To begin with, running headlines claiming that Reglan is safe based on the NEJM study was misleading and irresponsible because the majority of women, 2,502 out of 3,458, only took Reglan for 7 days, or less, in the first trimester. The average duration of fetal exposure was about a week. Only 164 took the drug for 22 days or more. Plus, the study only looked at harm at birth with no later follow-up on the babies.

There was no mention in the actual study of the black box for TD, or any other adverse effects, that could harm the mom or the fetus. Yet, the Los Angeles Times ran a June 10, story with claims that the “first study of the anti-nausea drug metoclopramide in pregnant women has found that it is safe for both fetuses and mothers.” The Times failed to mention any side effects but included the main talking point that as “many as 80% of pregnant women suffer morning sickness in the first trimester.”

Huge Customer Base

Over four million women give birth each year in the US, according to the CDC. The study reported that between 50% and 80% of pregnant women get morning sickness. Those numbers translate into between 2 and 3.2 million new Relgan customers in the US alone, year in and year out.

The women in the NEJM study took three 10mg tablets per day. The current price of Reglan at is $182 for 100 tablets. Each pregnant woman could buy 2 or 3 months of Reglan for the first trimester, plus the study notes that nausea and vomiting “can continue beyond the first trimester.” Two months of the drug at a cost of $364, times 2.5 million women, could potentially ring up $910 million each year.

Successful Campaign

It sounds like the study’s kick-off will definitely boost sales. “I think that women will be comforted by this,” Dr Keith Eddleman, director of obstetrics at Mount Sinai Medical Center in New York, told Johnson in an AP article. “Most women are reluctant (to take anti-nausea medicine) just because of the stories they’ve heard and the perception that taking something in the first trimester can cause harm.”

“There are very few drugs approved for use in the first trimester of pregnancy,” Dr Jennifer Niebyl, a professor of obstetrics and gynecology at the University of Iowa, told Time Magazine on June 10, 2009.

“But this study could lead to metoclopramide getting approved to treat morning sickness because this is good data with big numbers,” she said. “These findings may change practice and help people to be less hesitant to use the drug.”

Dr Laura Riley, a Massachusetts General Hospital obstetrician and spokeswoman for the Society for Maternal Fetal Medicine, told Johnson women are far more cautious than doctors about medication. “For some who are on the fence, it’ll allow them to take it.”

The chairman of obstetrics and gynecology at St John’s Health Center in Santa Monica, Dr James Moran, told the LA Times that he thinks the findings should be replicated but that he “wouldn’t hesitate to use Reglan at all.”

Infants heavily dosed

Reglan is also marketed off-label to nursing mothers to stimulate breast milk even though the medication guide warns women that the drug “can pass into breast milk and may harm your baby.”

Reglan is also used to treat GERD in newborns, especially premature babies. Any use with infants is off-label. Yet a study in the June 2006, Pediatrics journal titled, “Reported Medication Use in the Neonatal Intensive Care Unit: Data From a Large National Data Set,” found Reglan was one of the 10 drugs reported most commonly for the NICU.

A Medline abstract for a paper in the January 2005, Movement Disorders Journal, reported the “first documented case of tardive dyskinesia in an infant,” developed at 2 months “after a 17-day treatment with metoclopramide for gastroesophageal reflux.”

The “Pediatric Gastroesophageal Reflux Clinical Practice Guidelines,” in the October 2009, Journal of Pediatric Gastroenterology and Nutrition, warn that “Metoclopramide commonly produces adverse side effects in infants and children, particularly lethargy, irritability, gynecomastia, galacctorhea, and extrapyramidal reactions and has caused permanent tardive dyskinesia.”

An infant treated for GERD, born to a mother who took Reglan for morning sickness and to increase breast milk, would undergo triple exposure.

Women Need Warnings

“Women need to be aware of the potential risk Reglan poses to themselves and their children,” according to Roger Drake, the lead Reglan attorney at the California-based Baum, Hedlund, Aristei & Goldman law firm, in cases of persons who developed TD.

Concerns about tardive dyskinesia extend to children and infants, especially babies born prematurely, who may have been treated with Reglan to stimulate their digestive system, Drake reports.

He points out that no studies have been conducted to examine the risk of tardive dyskinesia in babies whose mothers take Reglan, even though the drug makers know that Reglan is used in such circumstances.

The adverse effects for babies are the same as for adults, he says, but infants are more at risk because there are no FDA approved dosing requirements established for the safe use of Reglan with children of any age, much less infants.

Baum Hedlund has two decades of experience representing thousands of injured clients against drug companies.

(This article is part of the Reglan Litigation Update Series and is sponsored by the Baum, Hedlund, Aristei & Goldman law firm

Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America., Home of the Pro-Pharma Censors

This is certainly not the first go-round with biased articles in favor of The MOTHERS Act from The Record, a newspaper in Robert Menendez’s home state of New Jersey (home to many of the world’s pharmaceutical companies).

Perhaps I’m biased but I don’t see anything wrong with the following comment which was not posted on NorthJersey’s website under the comments section for the article about Brooke Shields celebrating passage of The MOTHERS Act. I would like to open comments up here on this blog since is censoring us (God knows how many of us). So go ahead and comment here and I’ll attempt to post a link. This comment was made in response to Susan Stone’s statement that Carol Blocker is the main supporter of The MOTHERS Act and that they have “thousands” of signatures on a “petition” (the DBSA letter writing software) which has never been made public. Everyone who reads this blog knows the truth about the bill and how it was passed. It’s too bad that is censoring comments on The MOTHERS Act.

My unposted comment (I’ve tried about 5 times in the last 24 hours):

Did Carol Blocker donate between $13 and $16 million to the pHARMa front groups who pushed the bill, or God knows how much to DBSA to have them run the “petition?”

I am so glad I had my mom around to save me from the horrors of psychiatric drugs and I only wish that Melanie Stokes could have been spared the horror that befell her due to the idiotic mistreatment she was given by her doctors in the form of several different triple drug cocktails, cold turkey med switches, and repeated electroshock sessions which according to Melanie, were “killing her.”

We have 3,117 Facebook Coalition members and 13,453 public signatures (Name and State listed) on our actual live petition (and I would also like to thank them all).

It was posted in response to the following comment by Susan Stone:

Wednesday May 12, 2010, 12:08 AM – susan__3932 says:
I would like to thank the many national professional groups and thousands of women who signed the petition in support of the legislation which can be seen here: Please note the research and public awareness campaigns do not require additional funding and will be implemented by HHS and NIH. These life saving initiative – which are now law – will go a long way to informing assessment and treatment of perinatal mood disorders. Thank you all for supporting The Melanie Blocker Stokes MOTHERS Act. The bill’s lead supporter was none other than Carol Blocker, Melanie Blocker Stokes’ mother. Susan Dowd Stone, MSW, LCSW

Here is a running log of all the comments on their website so far.

  1. Wednesday May 12, 2010, 5:18 PM – AmyR.Philo says:
    This website is not allowing my comments. That’s ok, we can take our comments over to my blog.
  2. Wednesday May 12, 2010, 5:14 PM – Rebecca.R says:
    It is just so wonderful that this legislation has passed. I am grateful to all the advocates who made this possible. It’s tough to do battle against groups who use mother’s mental health to promote their agenda by instilling shame and doubt into already suffering moms. Thank you to Susan Dowd Stone for her fearless leadership in placing mom’s welfare above all else and ignoring those who would seek to implicate a dark motive to this life saving cause!
  3. Wednesday May 12, 2010, 4:10 PM – farallon says:
    This is just a make believe disease that gives some women an excuse for not taking care of their kids. You need to get off your butts and tend to your kids.
  4. Wednesday May 12, 2010, 2:24 PM – Kaerer says:
    I am appalled by the ignorance of some of the comments herein. It is evident that there are many people who have no idea how debilitating this disease can be. This bill’s passage comes from the blood sweat and tears of men and women who know firsthand what is lacking in the treatment of PPD. We should all be thankful for these advocates who have dedicated their lives and in many cases their own personal finances to help the victims of PPD. This bill is to promote AWARENESS, RESEARCH and EMOTIONAL SUPPORT for those who are suffering. It provides women and their families with different options, medication IS ONLY one of those options. The choice to medicate for any condition is still a choice and yes, the side effects must be taken into consideration but there again RESEARCH comes into play. IGNORANCE IS NOT BLISS! Please educate yourselves before making such disparaging comments regarding a bill that so many have worked so hard to pass. PPD victims have suffered long enough!
  5. Wednesday May 12, 2010, 12:41 PM – kkleiman says:
    It is truly rewarding to see how all of the preparation and hard work on behalf of postpartum women can now be put into practice. The effort to promote awareness is not an easy one. It necessitates a deep desire to support and treat women who suffer excruciating levels of distress along with good, accurate information. Without both, there is a great risk for tons of misinformation to get into the wrong hands. Thank you, Susan, for all you have done to facilitate this gratifying outcome.
  6. Wednesday May 12, 2010, 2:42 AM – BTKING says:
    It is estimated that 50% of all Suicides in the USA were those taking Antidepressant medications. My Cousin was one of such Cases. And now I had to have one of my family taken away all because people haven’t woken up to the deadly effects of these medications. Everyone who supports this bill needs to actually do their own research and get the actual scientific data regarding psychotropic medications. If you guys value the lives of your children, their children and the future generation as a whole, you WILL reconsider allowing this bill to threaten the lives of mothers and unborn babies thereof. This information is so hidden because Pharma has paid off media, Congressman, etc. with millions of dollars of drug profits just to keep it so. That is the ONLY reason it is not broadly known. So I implore everyone. Please stop this blatant violation of our basic…human …rights.
  7. Wednesday May 12, 2010, 2:19 AM – LindaKay says:
    Psychiatric drugs harm both mother and child. Babies are dying because their moms took antidepressants while pregnant. Many people get murderous and suicidal thoughts while on them, completely uncharacteristic of the way they were before they took the drugs. There is also a Yahoo forum with over 2300 people, both men and women, complaining of persistant sexual dysfunction after taking SSRIs. Many of them complain of what seems to be permanent genital anesthesia for years after discontinuing the drugs, and they don’t want to live. Antipsychotics and ECT cause major brain damage among other maladies. Melanie Stokes was given all these so-called “treatments” before she jumped out a 12 story window and to her death. Then they named the Mother’s Act after her.
  8. Wednesday May 12, 2010, 2:18 AM – LindaKay says:
    So many women exhaust themselves in trying to live up to the expectations of today’s society. If they are fortunate enough to be able to stay at home with their new babies, they may suddenly find themselves totally alone. If they work outside the home they may come home only to be kept up night after night when their children are sick, and they can become so sleep deprived that they become psychotic, even though otherwise they’d be perfectly normal. I think too much of postpartum depression is attributed to hormones. Much of it can be traced to loneliness, sleep deprivation, and poor nutrition, and I don’t think we need to spend 3 million dollars to find that out. What we DO need to do is encourage moms to take better care of themselves. They need to be with other moms as well as getting enough rest and necessary nutrients. We have to stop pushing them to be supermoms.
  9. Wednesday May 12, 2010, 12:37 AM – AmyR.Philo says:
    I believe I recall a petition you guys started that had about 28 signatures. We also have 4.6% of votes on a survey on my website in a survey for “The MOTHERS Act is life saving” compared to the other 95% opposed – the survey has been running for a while now… Oh and we have 54 groups opposed to the bill. None of them takes any money from pHARMa.
  10. Wednesday May 12, 2010, 12:08 AM – susan__3932 says:
    I would like to thank the many national professional groups and thousands of women who signed the petition in support of the legislation which can be seen here: Please note the research and public awareness campaigns do not require additional funding and will be implemented by HHS and NIH. These life saving initiative – which are now law – will go a long way to informing assessment and treatment of perinatal mood disorders. Thank you all for supporting The Melanie Blocker Stokes MOTHERS Act. The bill’s lead supporter was none other than Carol Blocker, Melanie Blocker Stokes’ mother. Susan Dowd Stone, MSW, LCSW
  11. Tuesday May 11, 2010, 11:39 PM – joelfrisco says:
    My wife was misdiagnosed with psychiatric conditions after our first child was born. Simple anxiousness from a formula related choking incident led to drug prescriptions and eventually psychiatric hospitalization due to those drugs. The hospital and doctors who led us through our first birth and post-partum experience educated us almost to the point of death. After the damage of that experience we chose a natural home birth for our second child with much happier results. We don’t need more education, we need the government and medical profession to back off and let Moms be guided by their family, faith and conscience, not pseudo-science and profit motivated businesses.
  12. Tuesday May 11, 2010, 10:43 PM – donnaferr says:
    And how exactly has psychiatry, The industry of Death, helped those who have suffered from depression? It has not. It has done nothing but drug people into apathy so they don’t care. Do not trust any group whose sole handling is to “drug it.”
  13. Tuesday May 11, 2010, 9:47 PM – AmyR.Philo says:
    Spend some time on the UNITE website & blog if you are interested in the full story. Or, you could just keep reading the nonsense from Susan Stone. There are thousands many babies dying from drug exposure and God knows how many mothers dying the same way Melanie Stokes died from drug-induced suicide. This bill does nothing to prevent or lessen that, it will only make it worse.
  14. Tuesday May 11, 2010, 9:47 PM – AmyR.Philo says:
    Susan’s favorite catch phrase is “the bill does not subsidize medication” – whatever that means, the result will be the same, which is more moms being drugged, and more babies being drugged. You would have to be a fool to think fewer mothers will wind up on medication as a direct result of the bill’s passage. Last point for this comment would be that the only reason The MOTHERS Act passed was because it was slipped into the health care bill. They tried the same thing in 2008 with the “Coburn” Omnibus and failed. Only by slipping it in to other legislation did the bill pass. It failed on its own lack of merits for about 8 years because the bill is not worthy of passage. And no matter how you look at it it would never have passed without back room deals and pharmaceutical funded lobbying.
  15. Tuesday May 11, 2010, 9:45 PM – AmyR.Philo says:
    Re: Susan Stone’s claims… Google Susan Stone MOTHERS Act Evelyn Pringle and find out all about her. As for a “minority” of people protesting, on the contrary, we have over 13,000 signatures against the bill and I have yet to see any public petition for the bill other than a listing of groups (many of whom are pharma front groups) who are in favor of it. The DBSA sponsored “petition” was a cap-wiz letter campaign for which all “petition signatures” were privately sent letters to Congress members. DBSA is a pharmaceutical funded front group. And Susan Stone’s favorite nonprofit PSI has many major members with pharmaceutical conflicts of interest.
  16. Tuesday May 11, 2010, 8:56 PM – farallon says:
    Postpartum depression is another of the new imaginary diseases psychiatrists make up. You had a baby, get over it and take care of the kid.
  17. Tuesday May 11, 2010, 4:02 PM – kps says:
    It is obvious that there is still much work to be done since ignorance is still rampant. This bill’s passage is the result of tireless efforts of advocates that have dedicated their professional and personal lives to the cause and the courage of women who relive the horror of this illness in order to educate and help others.This bill promotes awareness, research and support for those who are suffering. It avails women and their families with options, only one of which is medication. The decision to medicate for any condition is an individual choice for which side effects must be considered. Knowledge is power. It is time for all women to have ALL the resources to eradicate the “4 million years of evolutionary suffering” Karen P. Sackstein, CPA – PPD Survivor
  18. Tuesday May 11, 2010, 3:56 PM – susan__3932 says:
    Indeed the bill does NOT subsidize medication or encourage its usage. What it DOES do is promote more research, public awareness, education and services for pregnant and new mom’s struggling from these disorders. The minority who characterized the bill as a diabolical attempt to medicate America’s mothers, did not succeed in discouraging support with these misrepresentations, but instead stimulated the debate that further clarified the legislation’s true purpose and garnered more support from mothers, legislators and those from organizational and professional communities dedicated to helping them. You can read the bill here: Susan Dowd Stone, MSW, LCSW
  19. Tuesday May 11, 2010, 11:40 AM – AmyR.Philo says:
    You can’t trust people who tell you that antidepressants are safe or effective. The New Jersey Website Speak Up When You’re Down tells moms to use antidepressants for several months after all symptoms go away, and says it’s ok to use them while breastfeeding (it’s not). To learn the truth about The MOTHERS Act go here: Read how much money was funneled to the supporters of The MOTHERS Act from Pharmaceutical companies in recent years – over $13 million was spent.
  20. Tuesday May 11, 2010, 11:38 AM – AmyR.Philo says:
    This article makes me so sad, for all of the moms who are going to be told to listen to people like Susan Stone who commented above, and her friends who love to tell women to go on medication to treat or prevent PPD. Read this Mother’s Day blog entry from Christiane Schultz about the pain she is going through her second Mother’s Day after losing her son Matthew two hours after he was born to Effexor exposure during pregnancy. She also got pregnant after Matthew died but before she could wean off of Effexor and lost that baby as well. In fact, all of the babies she has had with the antidepressant Effexor have had some kind of problem from the exposure, including PPHN with one baby which nobody even told her about.
  21. Tuesday May 11, 2010, 11:33 AM – csrv says:
    Everyone is trying to save tax dollars. 4 million years of evolution has gotten us this far without postpartum issues. We all have own own little neurosis’s to deal with. Stop this spending when we can’t afford it!
  22. Tuesday May 11, 2010, 9:15 AM – susan__3932 says:
    As a speaker at yesterday’s event, celebrating the historic passage of this legislation, I encourage all women to continue to now encourage funding of this bill! You may demonstrate your support by going to and signing the petition in support of its funding! Sincerely, Susan Dowd Stone, MSW, LCSW Chair, President’s Advisory Council, Postpartum Support International, National Board Member, Healthy Mothers, Healthy Babies Coalition Author/Editor Perinatal and Postpartum Mood Disorders: Perspectives asnd Treatment Guide for the Healthcare Practitioner (Springer, 08).

And here is the article:

Brooke Shields hails passage of postpartum depression bill in Ridgewood visit
Monday, May 10, 2010
Last updated: Tuesday May 11, 2010, 6:21 AM

The Record

Actress Brooke Shields and former New Jersey First Lady Mary Jo Codey joined U.S. Sen. Robert Menendez in Ridgewood Monday to announce the passage of federal legislation to help women suffering from postpartum depression.

Shields, left, suffered debilitating postpartum depression  following the birth of her daughter Rowan Francis in 2003.

Shields, left, suffered debilitating postpartum depression following the birth of her daughter Rowan Francis in 2003.

Menendez, D-NJ, is advocating for $3 million to launch the program which calls for more research to better understand what causes the disorder that affects up to 20 percent of all new mothers and up to 16,000 women in New Jersey each year.

The law encourages the Department of Health and Human Services to make grants available for agencies to provide outpatient, inpatient and home-based health services for women with or at risk for postpartum conditions.

“We need to be able to educate, increase support services and research why it happens so new moms can feel safe rather than scared and alone,” said Menendez, a key sponsor of the legislation.

The law, The Melanie Blocker Stokes MOTHERS Act, was named after a Chicago woman suffering from postpartum depression who jumped to her death in 2001.

Shields, a statuesque former model and film and TV star, suffered debilitating postpartum depression following the birth of her daughter Rowan Francis in 2003. Shields had suicidal thoughts and was finally treated with medication and therapy, experiences she recounted in her book “Down Came the Rain: My Journey Through Post-Partum Depression,” published in 2005.

“I was in such a sad, sorry, scared and devastated state,” she said. “I was guilty. It was the worst time of my life.”

She encouraged women to report symptoms to their physicians so treatment can begin as soon as possible.

“Don’t diminish it,” she said. “Don’t be afraid to be honest.’’

Elements of the law were taken from New Jersey legislation championed by Codey and adopted into law in 2006.

New Jersey was the first state to require the screening of new moms for post-partum depression.

Following the birth of her first son, Codey suffered suicidal thoughts and worried she would harm her infant. She suffered through postpartum depression again when her second son was born and was also successfully treated.

She praised Menendez for raising awareness and harnessing more research dollars for women suffering from the disorder.

Franklin Lakes resident Sylvia Lasalandra recounted her battle with postpartum depression 10 years ago following the birth of her daughter, Melina. “I lost the first nine months of my daughter’s life,” she said.

In 2005, she self-published A Daughter’s Touch: One Woman’s Journey Through Postpartum Depression’’.

“I cry for the women too afraid to ask for help,’’ she said. “The MOTHERS Act means they will no longer be ignored.’’