Celebrating the 100th Issue of the Health Product InfoWatch!
Health Canada is publishing it’s 100th issue of the Health Product InfoWatch this month, a major milestone! The Health Product InfoWatch was launched in 2015 to replace the Canadian Adverse Reaction Newsletter and over the past 8 years has provided clinically relevant health product safety information to Canadian healthcare professionals. Topics have ranged from safety reminders, important updates to Canadian product monographs, information on medication errors, and, more recently, timely communications concerning COVID-19 vaccines and treatments. The Editorial Team would like to take this opportunity to thank readers for their continued interest.
Drug and vaccine authorizations and communications for COVID-19
New information and recent communications related to authorized COVID-19 vaccines and treatments are highlighted in this section.
Safety brief
Viral vector-based COVID-19 vaccines (Vaxzevria and JCOVDEN) and the risk of thrombosis with thrombocytopenia syndrome
In Canada, authorized viral vector-based COVID-19 vaccines include VaxzevriaFootnote * (AstraZeneca COVID-19 Vaccine) and JCOVDEN (Janssen COVID-19 Vaccine). Both vaccines are indicated for active immunization in individuals 18 years of age and older for the prevention of coronavirus disease 2019 (COVID-19).Footnote 1Footnote 2
Thrombosis with thrombocytopenia syndrome (TTS) is a very rare adverse event involving blood clots (thrombosis) with low platelets (thrombocytopenia). Reports of TTS following vaccination with viral vector-based COVID-19 vaccines first emerged in Europe in 2021. In response to this potential safety issue, Health Canada notified the public of these reportsFootnote 3, assessed the available dataFootnote 4Footnote 5 and, after confirming a possible link between the use of viral vector-based COVID-19 vaccines and TTS, communicated these findings.Footnote 6Footnote 7Footnote 8 Health Canada also worked with the manufacturers of Vaxzevria and JCOVDEN to update the Canadian product monographs for these products with warnings about TTS.Footnote 1Footnote 2
In March 2023, Health Canada completed a follow-up review of TTS that took into consideration recent CanadianFootnote 9 and international data. This review was triggered by an investigation conducted by the United States Food and Drug Administration that resulted in further restrictions to the authorized use of the Janssen COVID-19 Vaccine in the United States.Footnote 10
Overall, Health Canada’s follow-up review did not identify any new safety information; its findings were consistent with information previously published by the Department. As of October 31, 2022, there have been no reports of TTS following vaccination with JCOVDEN in Canada, and the majority of reports associated with Vaxzevria date back to 2021. A precise mechanism by which these vaccines cause TTS is still unknown.
The current Canadian product safety information for Vaxzevria and JCOVDEN remains accurate and accounts for the evolving nature of the data. Health Canada will continue to monitor the safety of viral vector-based COVID-19 vaccines and will take appropriate action should new health risks be identified.
Safety reminders
Healthcare professionals should be alert to, and inform vaccine recipients of, the signs and symptoms of thrombosis, thromboembolism, and/or thrombocytopenia following the administration of a viral vector-based COVID-19 vaccine.
The majority of cases of TTS occurred within 3 weeks following vaccination.
Clinical information on TTS is described in the Canadian product monographs for Vaxzevria and JCOVDEN.
Healthcare professionals are encouraged to report adverse reactions suspected of being associated with COVID-19 vaccines.
Gilead Sciences Incorporated recalled 2 lots of the cystic fibrosis drug Cayston (aztreonam) due to the potential of cracked glass vials in those lots, which may introduce glass particles into the medication.
Health Canada completed a safety review evaluating the risk of acute kidney injury associated with the use of cloxacillin-containing products. Health Canada’s review of the available information did not establish a link. Health Canada will work with the manufacturers to update the Canadian product monographs for cloxacillin-containing products to note that cases of acute kidney injury have been reported and to increase awareness of this potential risk.
In 2013, Istodax (romidepsin) was authorized under a Notice of Compliance with conditions for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma who are not eligible for transplant and have received at least one prior systemic therapy, pending the results of trials to verify its clinical benefit. Istodax is now available only under Celgene Inc.’s (a Bristol-Myers Squibb company) Restricted Access Program and should not be initiated in new patients. This is based on a Phase 3 confirmatory study that failed to demonstrate Istodax, in combination with chemotherapy, was more effective than chemotherapy alone at delaying the progression of PTCL.
Canada is experiencing a shortage of nitroglycerin 0.4 MG/ACT sprays due to supply issues with the raw materials used to make the sprays as well as an increase in demand. Health Canada is asking people to only obtain what they need from their pharmacy; keep expired product; and check the chart in the advisory to confirm which product(s) can be used beyond their Original (Printed) Expiry Date.
This safety review evaluated the risk of pericardial effusion associated with the use of Proglycem (diazoxide). Health Canada’s review of the available information found a possible link. Health Canada is working with the manufacturer to update the Canadian product monograph for Proglycem with a warning about cases of pericardial effusion having been observed, including in infants and children.
Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.
New health product safety information
The following topics have been selected to raise awareness and encourage reporting of adverse reactions.
Product monograph updates
The following safety labelling updates, which were recently made to the Canadian product monographs, have been selected for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada’s Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada’s Drug Product Database.
ella (ulipristal acetate)
The Warnings and Precautions, Drug-Drug Interactions, and Patient Medication Information sections of the Canadian product monograph for ella have been updated with instructions on initiating or resuming a regular hormonal contraceptive following the intake of ella.
Key messages for healthcare professionals:Footnote 1
Pharmacodynamic data shows that progestin-containing contraceptives may interfere with the ability of ella to delay ovulation.
If a woman wishes to initiate or resume a regular hormonal contraceptive, she can do so, no sooner than 5 days after the intake of ella provided she uses a reliable barrier method until her next menstrual period.
In addition, if a woman used ella due to a known or suspected failure of her hormonal contraception, refer to the prescribing information for that specific hormonal contraceptive for further instructions on what to do.
Purinethol (mercaptopurine)
The Serious Warnings and Precautions Box, Warnings and Precautions, Adverse Reactions, and Patient Medication Information sections of the Canadian product monograph for Purinethol have been updated with the risk of macrophage activation syndrome (MAS).
Key messages for healthcare professionals:Footnote 1
MAS is a known, life-threatening disorder that may develop in patients with autoimmune conditions, in particular with inflammatory bowel disease, and there could potentially be an increased susceptibility for developing the condition with the use of Purinethol.
If MAS occurs, or is suspected, evaluation and treatment should be started as early as possible, and treatment with Purinethol should be discontinued.
Physicians should be attentive to symptoms of infection such as Epstein-Barr virus and cytomegalovirus, as these are known triggers for MAS.
Notice of market authorization with conditions
A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.
Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.
The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada’s NOC database.
Columvi (glofitamab for injection): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the NOC/c policy, for Columvi (glofitamab for injection) concentrate for solution for intravenous infusion. Columvi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma (trFL), or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy. Patients should be advised of the conditional market authorization for this indication.
For the complete prescribing information and information available for patients/caregivers, please consult the Columvi Canadian product monograph. The product monograph can be accessed through Health Canada’s Drug Product Database, the Hoffmann-La Roche Limited website or by contacting Hoffmann-La Roche Limited at 1-888-762-4388. Contact the company for a copy of any references, attachments or enclosures.
Scope
This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.
Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Teletypewriter: 1-800-465-7735 (Service Canada)
Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.
Due to time constraints relating to the production of this publication, information published may not reflect the most current information.
*
COVISHIELD (Verity Pharmaceuticals Inc/Serum Institute of India, in partnership with AstraZeneca Canada Inc) is a viral vector-based COVID-19 vaccine that was also authorized for use in Canada; however, its authorization by interim order expired on September 16, 2021.
Skinstitut Holiday Gift Kits take the stress out of gifting
Toronto, October 31, 2024 – Beauty gifts are at the top of holiday wish lists this year, and Laser Clinics Canada, a leader in advanced beauty treatments and skincare, is taking the pressure out of seasonal shopping. Today, Laser Clincs Canada announces the arrival of its 2024 Holiday Gift Kits, courtesy of Skinstitut, the exclusive skincare line of Laser Clinics Group.
In time for the busy shopping season, the limited-edition Holiday Gifts Kits are available in Laser Clinics locations in the GTA and Ottawa. Clinics are conveniently located in popular shopping centers, including Hillcrest Mall, Square One, CF Sherway Gardens, Scarborough Town Centre, Rideau Centre, Union Station and CF Markville. These limited-edition Kits are available on a first come, first served basis.
“These kits combine our best-selling products, bundled to address the most relevant skin concerns we’re seeing among our clients,” says Christina Ho, Senior Brand & LAM Manager at Laser Clinics Canada. “With several price points available, the kits offer excellent value and suit a variety of gift-giving needs, from those new to cosmeceuticals to those looking to level up their skincare routine. What’s more, these kits are priced with a savings of up to 33 per cent so gift givers can save during the holiday season.
There are two kits to select from, each designed to address key skin concerns and each with a unique theme — Brightening Basics and Hydration Heroes.
Brightening Basics is a mix of everyday essentials for glowing skin for all skin types. The bundle comes in a sleek pink, reusable case and includes three full-sized products: 200ml gentle cleanser, 50ml Moisture Defence (normal skin) and 30ml1% Hyaluronic Complex Serum. The Brightening Basics kit is available at $129, a saving of 33 per cent.
Hydration Heroes is a mix of hydration essentials and active heroes that cater to a wide variety of clients. A perfect stocking stuffer, this bundle includes four deluxe products: Moisture 15 15 ml Defence for normal skin, 10 ml 1% Hyaluronic Complex Serum, 10 ml Retinol Serum and 50 ml Expert Squalane Cleansing Oil. The kit retails at $59.
In addition to the 2024 Holiday Gifts Kits, gift givers can easily add a Laser Clinic Canada gift card to the mix. Offering flexibility, recipients can choose from a wide range of treatments offered by Laser Clinics Canada, or they can expand their collection of exclusive Skinstitut products.
Brightening Basics 2024 Holiday Gift Kit by Skinstitut, available exclusively at Laser Clincs Canada clinics and online at skinstitut.ca.
Hydration Heroes 2024 Holiday Gift Kit by Skinstitut – available exclusively at Laser Clincs Canada clinics and online at skinstitut.ca.
LONDON (AP) — Most people have accumulated a pile of data — selfies, emails, videos and more — on their social media and digital accounts over their lifetimes. What happens to it when we die?
It’s wise to draft a will spelling out who inherits your physical assets after you’re gone, but don’t forget to take care of your digital estate too. Friends and family might treasure files and posts you’ve left behind, but they could get lost in digital purgatory after you pass away unless you take some simple steps.
Here’s how you can prepare your digital life for your survivors:
Apple
The iPhone maker lets you nominate a “ legacy contact ” who can access your Apple account’s data after you die. The company says it’s a secure way to give trusted people access to photos, files and messages. To set it up you’ll need an Apple device with a fairly recent operating system — iPhones and iPads need iOS or iPadOS 15.2 and MacBooks needs macOS Monterey 12.1.
For iPhones, go to settings, tap Sign-in & Security and then Legacy Contact. You can name one or more people, and they don’t need an Apple ID or device.
You’ll have to share an access key with your contact. It can be a digital version sent electronically, or you can print a copy or save it as a screenshot or PDF.
Take note that there are some types of files you won’t be able to pass on — including digital rights-protected music, movies and passwords stored in Apple’s password manager. Legacy contacts can only access a deceased user’s account for three years before Apple deletes the account.
Google
Google takes a different approach with its Inactive Account Manager, which allows you to share your data with someone if it notices that you’ve stopped using your account.
When setting it up, you need to decide how long Google should wait — from three to 18 months — before considering your account inactive. Once that time is up, Google can notify up to 10 people.
You can write a message informing them you’ve stopped using the account, and, optionally, include a link to download your data. You can choose what types of data they can access — including emails, photos, calendar entries and YouTube videos.
There’s also an option to automatically delete your account after three months of inactivity, so your contacts will have to download any data before that deadline.
Facebook and Instagram
Some social media platforms can preserve accounts for people who have died so that friends and family can honor their memories.
When users of Facebook or Instagram die, parent company Meta says it can memorialize the account if it gets a “valid request” from a friend or family member. Requests can be submitted through an online form.
The social media company strongly recommends Facebook users add a legacy contact to look after their memorial accounts. Legacy contacts can do things like respond to new friend requests and update pinned posts, but they can’t read private messages or remove or alter previous posts. You can only choose one person, who also has to have a Facebook account.
You can also ask Facebook or Instagram to delete a deceased user’s account if you’re a close family member or an executor. You’ll need to send in documents like a death certificate.
TikTok
The video-sharing platform says that if a user has died, people can submit a request to memorialize the account through the settings menu. Go to the Report a Problem section, then Account and profile, then Manage account, where you can report a deceased user.
Once an account has been memorialized, it will be labeled “Remembering.” No one will be able to log into the account, which prevents anyone from editing the profile or using the account to post new content or send messages.
X
It’s not possible to nominate a legacy contact on Elon Musk’s social media site. But family members or an authorized person can submit a request to deactivate a deceased user’s account.
Passwords
Besides the major online services, you’ll probably have dozens if not hundreds of other digital accounts that your survivors might need to access. You could just write all your login credentials down in a notebook and put it somewhere safe. But making a physical copy presents its own vulnerabilities. What if you lose track of it? What if someone finds it?
Instead, consider a password manager that has an emergency access feature. Password managers are digital vaults that you can use to store all your credentials. Some, like Keeper,Bitwarden and NordPass, allow users to nominate one or more trusted contacts who can access their keys in case of an emergency such as a death.
But there are a few catches: Those contacts also need to use the same password manager and you might have to pay for the service.
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Is there a tech challenge you need help figuring out? Write to us at onetechtip@ap.org with your questions.
The Canadian Paediatric Society says doctors should regularly screen children for reading difficulties and dyslexia, calling low literacy a “serious public health concern” that can increase the risk of other problems including anxiety, low self-esteem and behavioural issues, with lifelong consequences.
New guidance issued Wednesday says family doctors, nurses, pediatricians and other medical professionals who care for school-aged kids are in a unique position to help struggling readers access educational and specialty supports, noting that identifying problems early couldhelp kids sooner — when it’s more effective — as well as reveal other possible learning or developmental issues.
The 10 recommendations include regular screening for kids aged four to seven, especially if they belong to groups at higher risk of low literacy, including newcomers to Canada, racialized Canadians and Indigenous Peoples. The society says this can be done in a two-to-three-minute office-based assessment.
Other tips encourage doctors to look for conditions often seen among poor readers such as attention-deficit hyperactivity disorder; to advocate for early literacy training for pediatric and family medicine residents; to liaise with schools on behalf of families seeking help; and to push provincial and territorial education ministries to integrate evidence-based phonics instruction into curriculums, starting in kindergarten.
Dr. Scott McLeod, one of the authors and chair of the society’s mental health and developmental disabilities committee, said a key goal is to catch kids who may be falling through the cracks and to better connect families to resources, including quicker targeted help from schools.
“Collaboration in this area is so key because we need to move away from the silos of: everything educational must exist within the educational portfolio,” McLeod said in an interview from Calgary, where he is a developmental pediatrician at Alberta Children’s Hospital.
“Reading, yes, it’s education, but it’s also health because we know that literacy impacts health. So I think that a statement like this opens the window to say: Yes, parents can come to their health-care provider to get advice, get recommendations, hopefully start a collaboration with school teachers.”
McLeod noted that pediatricians already look for signs of low literacy in young children by way of a commonly used tool known as the Rourke Baby Record, which offers a checklist of key topics, such as nutrition and developmental benchmarks, to cover in a well-child appointment.
But he said questions about reading could be “a standing item” in checkups and he hoped the society’s statement to medical professionals who care for children “enhances their confidence in being a strong advocate for the child” while spurring partnerships with others involved in a child’s life such as teachers and psychologists.
The guidance said pediatricians also play a key role in detecting and monitoring conditions that often coexist with difficulty reading such as attention-deficit hyperactivity disorder, but McLeod noted that getting such specific diagnoses typically involves a referral to a specialist, during which time a child continues to struggle.
He also acknowledged that some schools can be slow to act without a specific diagnosis from a specialist, and even then a child may end up on a wait list for school interventions.
“Evidence-based reading instruction shouldn’t have to wait for some of that access to specialized assessments to occur,” he said.
“My hope is that (by) having an existing statement or document written by the Canadian Paediatric Society … we’re able to skip a few steps or have some of the early interventions present,” he said.
McLeod added that obtaining specific assessments from medical specialists is “definitely beneficial and advantageous” to know where a child is at, “but having that sort of clear, thorough assessment shouldn’t be a barrier to intervention starting.”
McLeod said the society was partly spurred to act by 2022’s “Right to Read Inquiry Report” from the Ontario Human Rights Commission, which made 157 recommendations to address inequities related to reading instruction in that province.
He called the new guidelines “a big reminder” to pediatric providers, family doctors, school teachers and psychologists of the importance of literacy.
“Early identification of reading difficulty can truly change the trajectory of a child’s life.”
This report by The Canadian Press was first published Oct. 23, 2024.
