Health Canada reviewing safety of controversial breastfeeding drug
Health Canada has launched a safety review of the psychological withdrawal symptoms associated with stopping or reducing use of a drug commonly prescribed to help women breastfeed.
The agency confirmed the review in an email to CBC News.
“A safety review is currently under way for domperidone and drug withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation,” the statement said.
Domperidone is approved in Canada to treat gastrointestinal disorders. Health Canada has never authorized its use as a lactation aid, but it is widely prescribed off-label for this purpose.
The Health Canada review follows a CBC News investigation into severe psychological effects that can occur when some women stop taking the drug. Women who spoke to CBC described anxiety, lack of sleep and thoughts of self-harm severe enough that in some cases they became incapable of caring for their children or returning to work. One woman described multiple attempts to take her own life.
CBC’s investigation also found domperidone is prescribed by some doctors to stimulate lactation at doses three to five times higher than what is recommended by both Health Canada and the drug manufacturer. Because this is not an approved use or dosage anywhere in the world, there are no large-scale clinical trials that shed any light on how often these side effects occur.
This makes it challenging for regulators like Health Canada to evaluate the safety of a drug for an off-label purpose, said Mina Tadrous, an assistant professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto who specializes in drug safety.
“The company may not have intended it for that, so the original clinical trials were not designed for that. And so it means that they have to look at different mechanisms to be able to evaluate the safety of these drugs,” he said.
That can include looking at data from other countries with larger populations, according to Tadrous.
Case studies document concerns
There are, however, case studies documenting the withdrawal effects, including three published in November 2022 in the peer-reviewed journal Breastfeeding Medicine. Domperidone blocks dopamine receptors in the brain, which stimulates the release of prolactin. This causes lactation, the authors note, but can also cause domperidone to act as an antipsychotic. The authors also noted withdrawal symptoms are typically less severe when women taper off the drug slowly.
The most recent case studies are from the United States, where domperidone is not approved by the Food and Drug Administration for any purpose. CBC’s investigation found some American women get the drug from doctors in Canada.
Health Canada will review “all relevant domestic and foreign case reports,” the statement said.
Reviews can result in Health Canada requesting more information, studies or monitoring by the manufacturer. They can also result in warnings to patients and health care providers, changes to how a drug is labelled or, if necessary, the withdrawal of a drug from the market “if the benefits no longer outweigh the risks of the product,” according to the statement released by the department.
“The decision to take action, including issuing a warning, is not based solely on the number of case reports, but on a comprehensive assessment of the information contained in these case reports,” Health Canada’s statement said.
“Should new safety risks be confirmed, Health Canada will take appropriate action and continue to keep Canadians informed.”
The distinction between quantity and quality of reports is important, Tadrous said, because large numbers of reports, especially from non-clinicians, may only indicate people believe there’s a connection between a drug and a reaction.
“That’s the lesson we’ve learned with vaccines, for example, where these adverse event systems are flooded,” he said.
“And so if you base something just on the number of reports without doing a thorough investigation and a different type of study design that reduces bias … you might reach a false conclusion.”
Health Canada has conducted multiple safety reviews of domperidone, most recently in 2021. Previous reviews confirmed the risk of serious abnormal heart rhythms and sudden cardiac death related to domperidone use. These reviews resulted in Health Canada introducing a maximum daily dose recommendation of 30 mg and restricting its use in patients with certain cardiac conditions or taking other drugs.
Canada: Fatal stabbing in Vancouver leaves city shaken – Hindustan Times
An Indo-Canadian has been arrested and has been charged with second-degree murder. The victim has been identified by the Vancouver Police Department as 37-year-old Paul Stanley Schmidt
Toronto: The city of Vancouver in British Colombia was left shaken after a person at Starbucks cafe was fatally stabbed, with an Indo-Canadian arrested for that alleged murder.
The incident occurred on Sunday, around 5.40pm and followed a brief altercation outside the outlet between two men.
The victim was identified by the Vancouver Police Department (VPD) on Monday as 37-year-old Paul Stanley Schmidt. Meanwhile, Inderdeep Singh Gosal, 32, has been charged with second-degree murder.
Police continue to seek additional witnesses to the crime. “We believe this homicide was witnessed by dozens of bystanders, and there may be people with information who have not yet come forward,” VPD Sergeant Steve Addison said, in a release.
“We particularly want to hear from anyone who was present in the moments before the stabbing, or anyone who has cell-phone video of the incident.”
Investigators don’t believe the victim and suspect knew each other. The release added that the “the circumstances that led up to the fatal stabbing remain under investigation”.
A police constable patrolling the area was flagged down “moments after” the stabbing occurred. The suspect was arrested at the crime scene. Officers attempted to save the victim’s life but he did not survive and succumbed to the injuries sustained after being rushed to hospital.
Raw footage of the incident posted online have gone viral throughout Canada, as they show the victim lying outside the Starbucks, surrounded by his own blood, and also the alleged murderer, walking in and out of the glass doors to the establishment. Another video shows Gosal being arrested and taken into custody by police.
Schmidt was the city’s sixth homicide victim of this year.
The apparent random act of violence attracted criticism of the law and order situation in Vancouver, among the major cities in Canada. Filmmaker Aaron Gunn tweeted, “Things are not getting better. They are still getting worse.”
Is femicide in Canada's Criminal Code? – CTV News
Advocates are pushing for the term femicide to be added to Canada’s Criminal Code, saying it would help raise awareness on the issue.
In 2020, a report by the Canadian Femicide Observatory for Justice and Accountability found that one woman or girl is killed every two and a half days in Canada. Femicide refers to homicides that target women and girls because of their gender.
Understanding the violence females face specifically, advocates are hoping for more awareness of femicide at the federal level.
“It’s really important that we name femicide,” Jennifer Hutton, CEO of Women’s Crisis Services of Waterloo Region, Ont, told CTV’s Your Morning on Tuesday. “There are some unique traits about femicide. It’s really about men’s violence against women.”
Hutton believes femicide should be in the Criminal Code to prevent tragedies through better understanding.
“Until we name it, then how can we change it?” she said.”When it’s a separate part of the Criminal Code, then we have better data to track it, so we know just how prevalent it really is.”
Femicide can include instances when a woman or girl is killed by an intimate partner, a non-intimate partner, or in an armed conflict. The term can also include women who are not the intended victim, but are killed in the femicide of another woman, too.
For Indigenous women and girls, Hutton says they are killed at six times the rate of non-Indigenous women and girls.
Hutton is partnering with Jenna Mayne, who hosts the podcast “She is Your Neighbour” focusing on femicide in Canada.
“We hear from survivors, we hear from family members who have lost women to femicide, and we hear from experts,” Mayne said. “I think these stories are difficult to hear, but they’re so important to hear too.”
To listen to the full interview click the video at the top of this article.
Grocery rebate coming in federal budget 2023
The 2023 federal budget will include a one-time “grocery rebate” for Canadians with lower incomes who may be struggling with the rising cost of food, CTV News has confirmed.
According to sources, the new measure will be unveiled in Tuesday’s federal budget and will help nearly 11 million lower-income Canadians.
The new measure would see eligible couples with two children receive a payment of up to $467, a senior would receive $225, while a single person would receive $234 dollars.
The benefit will be rolled out through the GST rebate system, once a bill implementing it passes in the House of Commons, according to sources. This move is essentially re-upping and re-branding the recent GST rebate boost.
The amounts expected to be offered are exactly what the Liberals offered through last fall’s doubling of the GST credit, a boost that was estimated to cost $2.5 billion and got all-party backing. It’s not expected that there will be a requirement to spend the rebate on groceries.
According to Statistics Canada’s latest inflation report, food prices rose 11.4 per cent year-over-year in January, nearly double the rate of inflation of 5.9 per cent and up from 11 per cent the previous month.
The increased cost of food has been the focus of a parliamentary study that’s seen grocery CEOs, including Loblaw chairman and president Galen Weston, grilled over grocery profits.
“I’ve been talking with Canadians from coast, to coast, to coast over the past many months hearing directly concerns around affordability, around the high cost of food, of rent, of so many different things. That’s why a big part of the budget will be focused on measures to help Canadians in targeted ways,” Prime Minister Justin Trudeau told reporters on Parliament Hill on Monday.
“Groceries will certainly be part of it but, there’s other things as well that we’re going to continue to do to be there for Canadians…I look forward to a great budget tomorrow.”
The NDP had been calling for the Liberals to double the GST tax credit. Reacting to the news, NDP Leader Jagmeet Singh said this measure “looks very much like… what we’ve been asking for, for a long time.”
Both Trudeau and Deputy Prime Minister and Finance Minister Chrystia Freeland have been hinting for weeks that the 2023 budget would include targeted affordability measures to directly help those feeling the pinch of inflation the most.
“This support will be narrowly focused and fiscally responsible. The truth is, we can’t fully compensate every single Canadian for all of the effects of inflation or for elevated interest rates,” Freeland said last week in a pre-budget speech signalling her priorities. “To do so would only make inflation worse and force rates higher, for longer.”
On Monday afternoon, the finance minister took part in a long-standing tradition of picking out a new pair of shoes to wear on budget day.
This year, Freeland opted for a pair of black heels that were on sale at Canadian retailer Simons, from the store’s in-house brand. She placed them in a reusable tote bag after purchase.
WHAT ELSE TO EXPECT IN BUDGET 2023?
With the economy expected to continue slowing in the months ahead, potentially leading to a recession, Freeland is facing calls for the massive fiscal document to include a plan to promote economic growth.
Amid Bank of Canada’s interest rate hikes, inflation cooled to 5.2 per cent in February. That’s down from 5.9 per cent in January, after 40-year record highs over the summer, reaching 8.1 per cent in June.
“What Canadians want right now is for inflation to come down and for interest rates to fall. And that is one of our primary goals in this year’s budget: not to pour fuel on the fire of inflation,” Freeland said in her pre-budget positioning speech.
At the same time, she signalled the 2023 federal budget will still be prioritizing “two significant and necessary investments”: the $46.2 billion in new funding included in the $196 billion federal-provincial health-care funding deals, and new measures to boost Canada’s clean industrial economy.
It’s the latter that government officials have signalled will get some attention in tomorrow’s budget, with several news outlets reporting there will be sizable—30 per cent, according to Reuters— new clean technology-focused tax credits to generate growth in the electrical vehicle supply chain and in critical mineral extraction and processing.
The November 2022 fall economic update had telegraphed that these kinds of credits and investments were ahead.
“Tomorrow…we’re bringing forward a budget that is focused on affordability and supporting Canadians… and creating great jobs for the middle class in a clean and growing economy. Those are the focuses that we’ve been laser focused on over the past many years,” Trudeau said in the House of Commons on Monday, fresh off of U.S. President Joe Biden’s visit, where the green economy was a central piece of discussion.
Canada’s clear focus on the clean transition comes in part out of a need for these sectors to remain competitive in the face of the U.S. Inflation Reduction Act, which offers billions of dollars in energy incentives south of the border.
The Canadian Press has also reported that Tuesday’s budget will include an increase to the withdrawal limit for a registered education savings plan (RESP) from $5,000 to $8,000; and a plan to go after hidden or unexpected consumer fees known as “junk fees” that inflate the overall cost of a product or service.
Finance Canada officials, who for some time have been parsing the stacks of pre-budget submissions from various industries and sectors, will also have to factor in the Liberals’ commitments to the New Democrats, with key planks of the two-party confidence deal due to come to fruition this year.
“We still want to see confirmation of the dental care expansion to include seniors, people living with disabilities and kids 18 and under. We really want this budget to save money for people, and that’s something really important for us,” Singh said.
With this budget, Conservative Leader Pierre Poilievre has called on the federal government to lower taxes, end “inflationary” spending, match new spending with savings, and improve housing affordability.
“He wants to take away everybody’s money, centralize it in his own hands, and promise that it will trickle down through his mighty bureaucracy… And there will maybe be a few little drops that get down to the people who actually earned it in the first place,” Poilievre levelled at the prime minister during Monday’s question period. “Will he cap government spending and put an end to the inflationary deficits, tomorrow?”
The fall economic statement issued in November 2022 projected the federal deficit at $36.4 billion in 2022-23, down from the $52.8 billion forecast in the April 2022 federal budget. Freeland also forecasted that federal coffers could be back to balance by 2027-28.
The 2023 federal budget is coming just ahead of a two-week break in the House of Commons, allowing Liberal MPs to then descend on their ridings to promote it to their constituents before coming back to the capital to work on getting the budget implementation legislation passed through the minority Parliament.
With files from CTV News’ Chief Political Correspondent Vassy Kapelos, and CTVNews.ca’s Michael Lee and Spencer Van Dyk
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