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.
HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.
The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.
Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.
“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”
The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.
A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.
Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.
“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.
Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.
The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.
“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.
This report by The Canadian Press was first published Sept. 11, 2024.
ST. JOHN’S, N.L. – Newfoundland and Labrador‘s chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.
Dr. Janice Fitzgerald says that so far this year, the province has recorded 230 confirmed cases of the vaccine-preventable respiratory tract infection, also known as pertussis.
Late last month, Quebec reported more than 11,000 cases during the same time period, while Ontario counted 470 cases, well above the five-year average of 98. In Quebec, the majority of patients are between the ages of 10 and 14.
Meanwhile, New Brunswick has declared a whooping cough outbreak across the province. A total of 141 cases were reported by last month, exceeding the five-year average of 34.
The disease can lead to severe complications among vulnerable populations including infants, who are at the highest risk of suffering from complications like pneumonia and seizures. Symptoms may start with a runny nose, mild fever and cough, then progress to severe coughing accompanied by a distinctive “whooping” sound during inhalation.
“The public, especially pregnant people and those in close contact with infants, are encouraged to be aware of symptoms related to pertussis and to ensure vaccinations are up to date,” Newfoundland and Labrador’s Health Department said in a statement.
Whooping cough can be treated with antibiotics, but vaccination is the most effective way to control the spread of the disease. As a result, the province has expanded immunization efforts this school year. While booster doses are already offered in Grade 9, the vaccine is now being offered to Grade 8 students as well.
Public health officials say whooping cough is a cyclical disease that increases every two to five or six years.
Meanwhile, New Brunswick’s acting chief medical officer of health expects the current case count to get worse before tapering off.
A rise in whooping cough cases has also been reported in the United States and elsewhere. The Pan American Health Organization issued an alert in July encouraging countries to ramp up their surveillance and vaccination coverage.
This report by The Canadian Press was first published Sept. 10, 2024.
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