Alberta drugs bought from Turkey posed serious risks to newborns, documents show

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Alberta’s use of acetaminophen imported from Turkey increased the risk of a life-threatening illness in neonatal patients, according to provincial government documents detailing some of the issues that plagued Premier Danielle Smith’s $75-million deal for children’s medication last winter.

The documents, obtained by The Globe and Mail through an access to information request, consist of 28 pages of e-mails between officials at Alberta Health, the government ministry and Alberta Health Services, the provincial health authority.

The Alberta government had procured the Turkish acetaminophen from Istanbul-based Atabay Pharmaceuticals to restock empty shelves amid a surge in pediatric respiratory illnesses. The documents show that the imported medication, which is thicker than products typically used by AHS, clogged feeding tubes used to deliver medicine to fragile patients in some instances. Tubes then had to be flushed with water.

Officials determined the higher volume of liquid increased the risk of a complication called necrotizing enterocolitis, which inflames the intestines of infants. Staff were subsequently ordered to stop using the product in neonatal intensive care units in May, according to AHS spokesperson Kerry Williamson, ahead of hospital-wide transition back to standard acetaminophen products in July. It is unclear how long the imported product was used for neonatal patients.

”Neonatal patients with very low body weight have fragile and incompletely developed intestines, which cannot accommodate large boluses of fluid administration for medications,” said Isaac Van Dyne, an executive associate with AHS, to Nicole Williams, the Health Minister’s chief of staff, in an Oct. 23 e-mail. His response, he wrote, was in relation to questions asked during a weekly call that included Health Minister Adriana LaGrange.

”The volume/osmolality issues from the Atabay acetaminophen was determined to possibly increase the risk of Necrotizing Enterocolitis (a potentially fatal injury to the intestines) in these tiny patients.”

The United Conservative government’s deal with Atabay has come under intense criticism for being ineffective and costly, but these documents show the medication resulted in adverse effects in young patients and indicate reports of children “gagging and refusing to take the medication.”

Alberta Health declined The Globe’s request for comment. Mr. Williamson of the AHS said in a statement that no patients developed necrotizing enterocolitis, were injured or fell ill as a result of taking the Atabay medication.

Ms. Smith announced in December, 2022, that the province had procured five million bottles of children’s acetaminophen and ibuprofen from Atabay. The deal was marred with delays and, only after the crisis had subsided, 1.5 million bottles touched down on Alberta soil.

The Globe previously reported that, of those bottles, just 13,700 were ever distributed to hospitals or pharmacies and that the province is unlikely to ever receive the outstanding 3.5 million units, despite paying tens of millions upfront. Still, the Premier has repeatedly defended the deal, saying the province will be prepared should there ever be another shortage in children’s fever-reducing medications.

Mr. Van Dyne, in his October e-mail, said nurses identified the clogs were in both gastric and nasal-gastric tubes, used when patients can’t take medications orally, and that increased volumes of water to flush these tubes was “not ideal.” He also stated that taste was a concern for the pediatric population because the Atabay medications were more bitter compared with North American products. Children had difficulty swallowing, not only because of taste but higher dosage requirements, he said.

In April and May last year, Mr. Van Dyne said, 10 submissions were put through the AHS Reporting and Learning system, which is an online portal that allows health care practitioners to voluntarily report adverse events, close calls and potential hazards. These submissions, from the Alberta Children’s Hospital, said children were gagging and refusing to take the medication.

Additionally, Mr. Van Dyne referenced several reports of “look-alike mix-ups” because the Atabay acetaminophen and ibuprofen bottles looked similar, “creating a risk for medication errors.”

There were also issues with pharmacy-bound Atabay products. Alberta Blue Cross, in March, alerted pharmacists that the Turkish medications had a lower dosage concentration and had to be kept behind the counter so that customers are informed on how to use it safely.

AHS, in an internal medication posting on July 10 last year, ordered its staff to stop using Atabay products and transition back to the typical, higher-strength products because the shortage had been resolved. Health Canada said the countrywide shortage of pediatric medications ended in April.

Alberta’s stock of Atabay ibuprofen will expire in November, 2025, and acetaminophen in January, 2026.

The provincial government has said it is working with the Turkish manufacturer to “explore options” to fulfill the remainder of the contract, but has repeatedly declined to provide additional details. However, in the e-mail from Mr. Van Dyne to Ms. Williams, he said they are hoping to fulfill the remainder of the contract – equivalent to $49.4-million – through the purchase of intravenous, or IV, acetaminophen.

“Our understanding is that Atabay is in the process of requesting approval from Health Canada but the process could take 6-12 months so we have not received any of the substitute product yet,” Mr. Van Dyne said.

However, Health Canada said in a statement to The Globe that it has not received any proposals for importing IV acetaminophen and that there is no shortage of that product.

It was only possible for Alberta to bring in some of the Atabay acetaminophen and ibuprofen because the country was facing an unprecedented shortage in these pediatric medications. The province had to go through Health Canada’s established approval process for foreign medications to ensure compliance with Canada’s safety, quality and efficacy requirements.

Part of the delay in getting the drugs to Alberta was ensuring that childproof caps and labelling conformed to Health Canada standards. Now that the shortage has been resolved, and another critical shortfall isn’t expected any time soon, Health Canada has said it is not currently considering applications for the exceptional importation of these drugs.