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Banned in the U.S., not approved for breastfeeding — why are so many moms taking this drug?

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WARNING: The story contains details about suicidal thoughts and attempts.

For Jamie Robinson, the changes were subtle at first.

She found herself playing with her hair and bumping into things. But soon, she was having six or seven panic attacks a day. Things then escalated to intrusive thoughts to take her own life and punch herself in the face. Robinson, 39, knew at that point something was terribly wrong.

“I’m looking at my own baby,” the Montreal woman recalled, “this warmth that floods me had just died completely.”

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“This reoccurring thought that she had been replaced, that this was not my baby, that this was maybe even a robot baby because there was no emotional engagement from my side… And the emotions are rushing to that space. The guilt, the feeling of panic. Like, am I a bad mom? Am I losing my mind?”

When her psychologist saw the distress she was in, she zeroed in on a breastfeeding medication Robinson had recently stopped taking. The medication was domperidone, a gastrointestinal drug that can also induce lactation.

But domperidone also acts as an antipsychotic, and psychologist Karen White believes Robinson was suffering withdrawal symptoms.

“[It] kind of clicked because I’ve seen people have very extreme reactions to stopping different medications,” White recalled. “And we kind of went, ‘oh, that could be it.'”

Jamie Robinson and her daughter Emma read on the couch of their Montreal home. Robinson says she suffered debilitating side effects from a medication she was taking to breastfeed. (Esteban Cuevas Gonzalez/CBC News)

Drug prescribed off-label

Domperidone, which blocks dopamine in the brain, is approved in Canada as an aid to speed up digestion, but it also has a side effect: lactation. Doctors and midwives routinely prescribe it off-label for this purpose. More than 120 million prescriptions for domperidone were filled in 2020, according to Health Canada.

Thousands of mothers describe it in online forums as a wonder drug that helped them produce enough milk to breastfeed their babies.

“It kind of sounded like a miracle drug,” said Emily Matreal, 29, who lives just outside Detroit and took domperidone in 2021 to help her breastfeed her son, Conner.

Emily Matreal, who lives just outside Detroit, took domperidone when her breastmilk supply dropped off suddenly, three months after her son Conner was born. (Emily Matreal)

Health Canada told CBC that although the agency is aware the drug is routinely prescribed to stimulate lactation, it is not approved for that purpose.

CBC spoke with nine women in Canada, the U.S. and Australia who say they had debilitating psychological side effects when they tried to come off the drug. They described extreme anxiety, panic attacks, insomnia and intrusive thoughts so severe they were left unable to function or care for their children, often for months. Some were forced to stop working or move in with family. At least one attempted to take her own life. They all say no one warned them these things could happen.

Multiple experts interviewed by CBC said they believe such side-effects are rare.

“It’s very unpredictable,” said researcher Janet Currie, who wrote her doctoral thesis on postpartum domperidone prescriptions in British Columbia. She says she’s helped between 15 and 20 postpartum women with severe psychological side effects slowly taper off the drug in the last year.

“No one can tell you exactly in advance whether you’ll have these symptoms and how intense they will be.”

Domperidone is not approved as a lactation aid anywhere in the world and there are no large-scale clinical trials that shed any light on how often these side effects occur.

 

 

Domperidone Warning

 

Health Canada has issued a safety alert about a drug that’s popular with nursing mothers.

Canadian data does not give the reason a person was prescribed a drug. But a CBC analysis of partial data from B.C., Saskatchewan, Manitoba and publicly-insured residents of Quebec found that of the nearly two million people prescribed domperidone between 2000 and 2021, more than three-quarters were women in their childbearing years.

The only published accounts of severe psychological withdrawal symptoms are case studies, including three published last month in the Journal of Breastfeeding Medicine.

Health Canada has issued several warnings about domperidone, but for cardiac side effects, not withdrawal symptoms. In 2012, 2015, and 2022,  the agency noted it can cause irregular heart rates and sudden cardiac death.

Health Canada’s warnings about domperidone, which echo those from the manufacturer in the product monograph, say it should be prescribed at doses no higher than 30 milligrams per day for the shortest possible period. The European Medicines Agency has similar guidelines.

Banned in the U.S.

In the United States, domperidone is banned, for any purpose, by the Food and Drug Administration (FDA) due to cardiac risks. But the FDA ban hasn’t stopped Americans desperate to breastfeed, like Matreal outside Detroit, from seeking it out.

When Matreal’s breast milk supply dropped off at three months postpartum, she posted in a Facebook mom’s group asking for advice. That was where she learned about domperidone — and how to get it in the U.S., through a well-known Canadian doctor.

“I thought, ‘well, that sounds safe. I will reach out to the doctor and kind of see how this goes’,” Matreal said.

Dr. Jack Newman is a pediatrician and expert on breastfeeding based in Toronto. He says he has been prescribing domperidone for decades to help with lactation. (CBC)

That doctor is Jack Newman, a pediatrician who runs the International Breastfeeding Centre in Toronto and is one of the best-known physicians in the field. Newman’s books and online reference materials on using domperidone to stimulate lactation are widely cited as evidence the medication is safe for this purpose in breastfeeding support groups with members around the world.

In an interview with CBC, Newman emphasized that if women were well supported by the health-care system to breastfeed from the beginning, domperidone wouldn’t be needed. Lactation consultants at his clinic watch mothers nurse and recommend other techniques, such as correcting a latch or breast compression, before turning to medication, he added.

He says the risks identified by regulators are overblown.

“We’ve never had a mother have a cardiac arrest. And I’m talking about thousands of mothers that we’ve treated over the years,” Newman said.

“The dose of domperidone that Health Canada recommends —  it’s not a ‘you must do this’ — is useless, it’s not going to work. And so we with experience know that three tablets three times a day, and sometimes we go higher than that, actually helps, and it helps in the majority of mothers.”

Newman starts patients at 90 milligrams per day — three times Health’s Canada’s maximum daily recommendation — and sometimes goes as high as 160 milligrams.

‘Our lives kind of started to unravel’

Matreal paid $100 and was able to get a virtual appointment with a lactation consultant at Newman’s International Breastfeeding Centre in Toronto the next day.

The consultant presented her case to Newman, who prescribed domperidone at 90 milligrams per day. The clinic sent the prescription to a pharmacy in Vancouver, which shipped the medication to Matreal’s doorstep.

When her breast milk supply didn’t increase, Matreal got in touch with the lactation consultant at the clinic, who recommended increasing the dose to 120 milligrams.

At this dose, Matreal said she started producing “a good amount of milk.” Three months later, she decided to stop taking the drug.

Matreal says she was warned by the Newman clinic to wean slowly so her milk supply was not disrupted, and that there could be some anxiety. She tapered slowly at first, but then, in her eagerness to be done with pumping and freezing milk, decided to stop altogether.

Emily Matreal says she started to experience symptoms such as dry eyes and hot flashes within days of going off domperidone. (Emily Matreal)

Two days after going off the drug, Matreal noticed changes: dry eyes, hot flashes and sweating.

“There was just a deep feeling of panic. I didn’t have an appetite, I couldn’t eat, I couldn’t unwind, I couldn’t sleep…. And then our lives kind of started to unravel from there.”

Matreal tried to get answers from the medical community, including from Newman. In an email dated Oct. 10, 2021, viewed by CBC, she wrote to Newman, saying she was “suffering horrible, horrible anxiety” trying to come off the drug.

In an email response the next day, also viewed by CBC, Newman suggested she either take an anti-anxiety medication her doctor had recommended, or go back on domperidone and wean “very slowly, over six months, say.”

“Your situation is very unusual, by the way, since I have not heard of anyone having symptoms like you describe after only three months of taking it,” he added.

Matreal tried going back on domperidone, she said, but her symptoms persisted. She said she found some comfort when she went back to the online mom’s forums and found dozens of other women who said they experienced the same symptoms when they stopped taking the drug.

Emily Matreal says she lost the ability to care for her son Conner after she stopped taking domperidone. (Emily Matreal)

‘Heartbreaking’

It’s a familiar story to Dr. Kaitlyn Krutsch, an assistant professor at the InfantRisk Center at the Texas Tech University Health Sciences Center School of Medicine, and author of three recently published case studies on domperidone withdrawal.

The Center, which studies the amounts of drugs that get into breastmilk, gets about half a dozen calls a week from American women in crisis trying to come off domperidone and unable to find answers from their doctors, Krutsch said. Women are reluctant to disclose they’ve been taking a banned drug, Krutsch explained. And even when they do, she said, American doctors don’t know what it is.

Many of the women, she added, get the drug from Canada.

“It’s heartbreaking,” she said. “A lot of times we’ll hear from the same moms over and over that they’re really struggling, that they’re having a lot of trouble with depression, that they’re having trouble functioning in their daily lives, that they don’t want to get out of bed. We even hear that they are suicidal.”

Krutsch said domperidone withdrawal can look a lot like postpartum depression, which can lead some health-care providers to assume that’s what’s wrong.

But there are important differences, Krutsch noted. In the case studies she published, women would experience symptoms within days of stopping the drug. When they went back on, symptoms would wane, she explained. In addition, one of the women in her case study was an adoptive mother who used domperidone to induce lactation. She was never pregnant.

Montreal psychologist Karen White suspects domperidone withdrawal was responsible for the sudden appearance of extreme anxiety in one of her patients. (Esteban Cuevas Gonzalez/CBC News)

In Montreal, Robinson’s psychologist Karen White also had her doubts that what she was seeing was postpartum depression. White, who has Robinson’s permission to discuss her case with CBC, said Robinson had what she considered to be a normal amount of anxiety for a first-time parent after the birth.

But when White saw Robinson several months later, Robinson’s level of distress alarmed her.

“I’ve seen very severe postpartum depression and anxiety, and this looks similar, but occurring so long after the birth and when she had been doing very well, didn’t make sense to me.”

Robinson says a lactation consultant at the Herzl-Goldfarb Breastfeeding Clinic in Montreal suggested she try domperidone. A doctor working at the clinic prescribed it.

The Herzl-Goldfarb clinic did not respond to a request for comment.

 

 

Addressing gaps in the system for perinatal mental health

 

A Manitoba mother with postpartum depression says she was dismissed by an emergency room physician last month when she sought help after having suicidal thoughts. Instead, she left the hospital feel ashamed and judged.

‘It would be better for everybody’

Matreal eventually stopped getting out of bed. She and her husband sold their house and moved in with Matreal’s parents so her mother could help take care of the baby. Unable to function, Matreal says she started to feel like a burden.

She tried to take her own life shortly after Conner turned one, and again around Mother’s Day.

“I 100 per cent felt like if I wasn’t here anymore, causing all of this, it would be better for everybody,” she said.

When CBC discussed Matreal’s case with Newman, he said anyone prescribed through his clinic gets comprehensive information about how to wean off domperidone slowly and is welcome to get in touch with the lactation consultants at the clinic if they run into problems.

Around the time she took this photo, Emily Matreal’s mental health deteriorated to the point where she stopped leaving the house or getting out of bed. (Emily Matreal)

He said such side effects are rare in his patients, and what’s more likely is the drug was masking symptoms of postpartum depression or anxiety that were already there.

“What is common in our patients, or anybody’s patients, is postpartum depression or anxiety. These mothers have been on the domperidone for several months and then small amounts of domperidone enter into the brain and act as an antidepressant. And when they go off it, especially if they go off it quickly, [they have] symptoms of maybe what is really the postpartum depression rather than the effect of the domperidone,” he said.

He said he prescribes the drug to American women about five or six times every few weeks, and that the FDA’s reasons for banning the drug are baseless.

“The FDA has said a lot of rubbish in the years …and they’re wrong about domperidone, to say it’s a particularly dangerous drug.”

Newman added that in the U.S., domperidone “isn’t actually banned because veterinarians can use it. So, you know, a million-dollar race horse is much more important than a mother.”

Asked if he’s ever advised American women to get the drug from a veterinarian, Newman replied: “Yes, but they don’t do it.”

Newman also said the clinic’s patients are warned about psychological withdrawal effects if they don’t taper off slowly, but CBC found no evidence of such warnings in reviewing the documentation Matreal received from his clinic.

The website of Newman’s International Breastfeeding Centre notes some women can experience anxiety and depression if they stop taking the drug too quickly, but says it is unlikely domperidone is responsible and that the same thing can happen to women who abruptly stop breastfeeding.

The College of Physicians and Surgeons of Ontario says doctors who provide care in other jurisdictions must do so in compliance with the college’s drug prescription guidelines  — “as well as any relevant legal or professional obligations in their patient’s jurisdiction,” the college said in a statement.

Sharing the stories

A year after she stopped taking domperidone, Matreal laughs as she lunges for a toy Conner tosses in her direction as he toddles by. The family has moved into their own apartment and life is starting to feel normal again, she said.

“When I hear music, it kind of feels good again, and I’m spending time with my son.”

Matreal said she wants to share her story because hearing from other women who had been through the same thing was what helped her when she was at her lowest.

Emily Matreal, pictured here with husband Tyler and son Conner, says life is starting to feel normal again a year after she stopped taking domperidone. (Chelsea Gomez/CBC News)

“It was displayed as an overall pretty safe drug, but then it’s so powerful that it can flip your life upside down,” she reflected.

“I guess that’s been the biggest thing, is just wanting to get my story out there and try to help people and kind of make them more aware that it might not just be a drop in breast milk and some anxiety. It could be a lot more.”

Back in Montreal, Robinson has created a website where she posts stories of other mothers who have had traumatic withdrawals from domperidone.

She said she’s doing it so other women have the information she was never given.

“I think that if women knew what the potential risk was … I don’t think almost any mother would take this risk of not being able to care for their child. It’s a nightmare.”


If you or someone you know is struggling, here’s where to get help:

CBC obtained data on the number of domperidone prescriptions from B.C., Saskatchewan and Manitoba, broken down by age range and gender, from the Canadian Institute for Health Information. Data from B.C. and Saskatchewan was from 2006-2021. Data from Manitoba was from 2015-2021. CBC designated “childbearing years” for these provinces as 15-54 (the 15-24 through 45-54 age buckets).

Data for Quebec came from the Régie de l’assurance maladie du Québec and included prescriptions for domperidone between 2000 and 2021 for publicly insured residents, which constitutes just under half the province. CBC designated “childbearing years” for Québec as 11-50 (the 11-20 through 41-50 age brackets). In total, the data included prescriptions for 1,974,475 unique individuals. The data did not include the reason the person was prescribed domperidone.

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Governments seek buyer as Quebec COVID-19 vaccine manufacturer Medicago set to close

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MONTREAL — The Quebec government says it’s looking to find a buyer for Medicago Inc., the Quebec-based COVID-19 vaccine manufacturer that will be shut down by parent company Mitsubishi Chemical.

Quebec Economy Minister Pierre Fitzgibbon said Friday the province has had preliminary talks with potential buyers in the pharmaceutical sector to keep Medicago’s expertise and skilled workforce in Quebec. He said both the Quebec and federal governments would be willing to put in money to secure a deal.

“We can’t operate it ourselves; the government will not be the main shareholder,” Fitzgibbon said. “But if there is a pharmaceutical company that considers it’s worth continuing, we’re ready to help.”

Mitsubishi Chemical said Thursday it would stop marketing the Medicago-produced Covifenz vaccine, which is plant-based and was approved by Health Canada one year ago for adults aged 18 to 64.

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The Japanese chemical company said it had been preparing to commercially produce the Covifenz vaccine but decided against doing so because of the “significant changes” in the COVID-19 vaccine environment. The company said it would dissolve Medicago because it is no longer “viable” to continue marketing its products.

“In light of significant changes to the COVID-19 vaccine landscape since the approval of Covifenz, and after a comprehensive review of the current global demand and market environment for COVID-19 vaccines and Medicago’s challenges in transitioning to commercial-scale production, the (company) has determined that it will not pursue the commercialization of Covifenz,” Mitsubishi Chemical said in a statement.

Following the announcement, Medicago issued a statement thanking its employees. “The Medicago team has pushed scientific boundaries and we know that they will continue to make incredible contributions to innovation and biopharmaceutical’s sector.”

Canada invested $173 million in Medicago in 2020 to support development of the Covifenz vaccine and help Medicago expand its production facility in Quebec City.

On Thursday, Innovation, Science and Industry Minister François-Philippe Champagne told reporters the federal government is in “solution mode.”

“Our first order of business is really to try to find a partner who can help us preserve the jobs, preserve the technology and the intellectual property,” Champagne said.

The minister acknowledged that mRNA vaccine technology for COVID-19 became dominant as it “seemed to be most effective.”

But Medicago’s plant-based vaccine was still “promising,” Champagne said.

“Everyone agreed that the plant-based vaccine could very well help in a future pandemic,” Champagne said.

Speaking to reporters on Montreal’s South Shore Friday, Fitzgibbon said the company informed the province at the end of December it intended to pull the plug on Medicago.

In May 2015, Quebec and Ottawa announced loans of $60 million and $8 million, respectively, for the construction of a complex in the Quebec City region to house Medicago’s activities.

“The challenge is not (getting the loan repaid), it’s how we can save the jobs, save this company,” Fitzgibbon said.

While Canada authorized Medicago’s vaccine in February 2022, it was rejected for emergency use by the World Health Organization in March because tobacco company Philip Morris was a minority shareholder in the company, contravening a policy adopted in 2005 by the United Nations agency.

Quebec City Mayor Bruno Marchand said on Twitter he was saddened by the closure of the company.

“My thoughts are with the families who learned some very sad news,” Marchand said Thursday evening. “We have to roll up our sleeves to keep all this expertise in the field of health innovation in Quebec City.”

This report by The Canadian Press was first published Feb. 3, 2023.

 

Sidhartha Banerjee, The Canadian Press

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Bird flu keeps spreading beyond birds. Scientists worry it signals a growing threat to humans, too

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As a deadly form of avian influenza continues ravaging bird populations around much of the world, scientists are tracking infections among other animals — including various types of mammals more closely related to humans.

Throughout the last year, Canadian and U.S. officials detected highly pathogenic H5N1 avian flu in a range of species, from bears to foxes. In January, France’s national reference laboratory announced that a cat suffered severe neurological symptoms from an infection in late 2022, with the virus showing genetic characteristics of adaptation to mammals.

Most concerning, multiple researchers said, was a large, recent outbreak on a Spanish mink farm.

Last October, farm workers began noticing a spike in deaths among the animals, with sick minks experiencing an array of dire symptoms like loss of appetite, excessive saliva, bloody snouts, tremors, and a lack of muscle control.

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The culprit wound up being H5N1, marking the first known instance of this kind of avian influenza infection among farmed minks in Europe, notes a study published in Eurosurveillance this month.

“Our findings also indicate that an onward transmission of the virus to other minks may have taken place in the affected farm,” the researchers wrote.

Eventually, the entire population of minks was either killed or culled — more than 50,000 animals in total.

That’s a major shift, after only sporadic cases among humans and other mammals over the last decade, according to Michelle Wille, a researcher at the University of Sydney who focuses on the dynamics of wild bird viruses.

“This outbreak signals the very real potential for the emergence of mammal-to-mammal transmission,” she said in email correspondence with CBC News.

It’s only one farm, and notably, none of the workers — who all wore face shields, masks, and disposable overalls — got infected.

But the concern now, said Toronto-based infectious disease specialist Dr. Isaac Bogoch, is if this virus mutates in a way that allows it to become increasingly transmissible between mammals, including humans, “it could have deadly consequences.”

“This is an infection that has epidemic and pandemic potential,” he said. “I don’t know if people recognize how big a deal this is.”

 

‘Explosive’ avian flu surge hits global bird populations

Global bird populations are being ravaged by a deadly strain of avian flu, wiping out flocks of domestic poultry and killing wild birds. Some researchers warn the virus could eventually evolve to better infect humans and potentially start a future pandemic.

H5N1 has high mortality rate

Among birds, the mortality rate of this strain of highly pathogenic avian influenza can be close to 100 per cent, causing devastation to both wild bird populations and poultry farms.

It’s also often deadly for other mammals, humans included.

The World Health Organization (WHO) has documented 240 cases of H5N1 avian influenza within four Western Pacific countries — including China, Cambodia, Laos, and Vietnam — over the last two decades. More than half of the infected individuals died.

Global WHO figures show more than 870 human cases were reported from 2003 to 2022, along with at least 450 deaths — a fatality rate of more than 50 per cent.

Bogoch said the reported death toll may be an overestimate, since not all infections may be detected, though it’s clear people can “get very, very sick from these infections.”

Most human infections also appeared to involve people having direct contact with infected birds. Real-world mink-to-mink transmission now firmly suggests H5N1 is now “poised to emerge in mammals,” Wille said — and while the outbreak in Spain may be the first reported instance of mammalian spread, it may not be the last.

“A virus which has evolved on a mink farm and subsequently infects farm workers exposed to infected animals is a highly plausible route for the emergence of a virus capable of human-to-human transmission to emerge,” she warned.

Louise Moncla, an assistant professor of pathobiology at the University of Pennsylvania school of veterinary medicine, explained that having an “intermediary host” is a common mechanism through which viruses adapt to new host species.

“And so what’s concerning about this is that this is exactly the kind of scenario you would expect to see that could lead to this type of adaptation, that could allow these viruses to replicate better in other mammals — like us.”

Government workers wear protective gear to collect poultry for slaughter during an outbreak of avian influenza on the Ivory Coast. More than 70 countries have reported cases this year, according to the World Organisation for Animal Health.
Government workers wear protective gear to collect poultry for slaughter during an outbreak of avian influenza on the Ivory Coast. More than 70 countries reported cases in 2022, according to the World Organisation for Animal Health. (Legnan Koula/EPA-EFE)

Surveillance, vaccines both needed

What’s more reassuring is the ongoing development of influenza vaccines, giving humanity a head start on the well-known threat posed by bird flu.

Wille noted the earlier spread of H7N9, another avian influenza strain which caused hundreds of human cases in the early 2010s, prompted similar concern that the virus would acquire the mutations needed for ongoing human-to-human transmission.

“However, a very aggressive and successful poultry vaccination campaign ultimately stopped all human cases,” she added.

But while several H5N1 avian influenza vaccines have been produced, including one manufactured in Canada, there’s no option approved for public use in this country.

To ward off the potential threat this strain poses to human health, Bogoch said ongoing surveillance and vaccine production needs to remain top-of-mind for both policy makers and vaccine manufacturers.

Dr. Jan Hajek, an infectious diseases physician at Vancouver General Hospital, also questioned whether it’s time to wind down global mink farming, given the spread of various viruses, from avian influenza to SARS-CoV-2, the virus behind COVID-19.

“We’re closely related to minks and ferrets, in terms of influenza risks … if it’s propagating to minks, and killing minks, it’s worrisome to us,” he said.

In 2021, B.C. officials announced an end to mink farming across the province, saying the farms can be reservoirs for viruses and represent an ongoing danger to public health. All mink farm operations must be shut down, with all of the pelts sold, by April 2025.

However, other provinces — and plenty of countries — do intend to keep their mink farms operating.

“Is it responsible to have these kinds of farming conditions where these types of events can occur?” questioned Moncla. “If we’re going to keep having these types of farms, what can we do to make this safer?”

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6,654 students facing suspension due to out-of-date immunization records

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The Windsor-Essex County Health Unit (WECHU) has issued about 6,654 suspension orders to students who do not meet immunization requirements.

WECHU completed a review of all elementary student immunization records in December and more than 12,000 students received a notice.

These students were either overdue for one or more vaccines required to attend school, or their immunization records were not updated with the health unit.

“While many of these vaccines are normally administered by primary health care providers, parents and guardians of children who received their vaccines from their health care provider still need to report this information to the health unit,” said a WECHU news release.

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The Immunization of School Pupils Act (ISPA) (1990), Section 11, Subsections (1) and (2) requires public health units to maintain and review vaccine records for every student attending school and to enforce a school suspension for incomplete immunization information. As the next step of the ISPA enforcement process, orders were mailed out to students that do not meet this requirement.

WECHU said this is the final notice.

The suspension order notifies parents and guardians that immunization records must be updated to the WECHU by Thursday, March 16, at 6 p.m. or their child will be suspended for up to 20 days from school, starting Monday, March 20, 2023. Once parents and guardians provide the missing immunization information to the WECHU, the student is removed from the suspension list and can attend school again.

Under the ISPA , children can be exempted from immunization for medical reasons or due to conscience or religious belief.

Families can book immunization appointments with their health care provider and are reminded to update their child’s immunization records online at immune.wechu.org.

Catch-up immunization clinics are also being offered at the WECHU Windsor and Leamington offices and will continue until the end of March. Families can book an appointment at a WECHU clinic by visiting wechu.org/getimmunized or by calling the WECHU at 519-960-0231.

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