By Dennis Thompson
Within the first month of the recall, there was a 55% increase of people coming to Ontario-area emergency departments complaining of high blood pressure, said lead researcher Cynthia Jackevicius. She is a senior scientist with the Institute for Clinical Evaluative Sciences, in Toronto.
Some of these patients likely were valsartan users who stopped taking the blood pressure med after seeing scary recall news citing a potential carcinogen found in some lots of the drug, Jackevicius said.
"Nine out of 10 did have an alternative replacement" for valsartan within three months. "However, that means that one out of 10 did not," Jackevicius said.
"That's a little bit concerning, that some of these patients may have either been confused or concerned, and decided not to switch to another medication," she added.
The recall occurred in July 2018 in both Canada and the United States, after generics maker Mylan Pharmaceuticals detected trace amounts of a probable cancer-causing chemical called N-nitrosodiethylamine (NDEA) in valsartan meds.
It was an unusually large recall that involved intense media interest, and Jackevicius and her colleagues wondered how it might have affected the drug's users.
So they turned to Canadian prescription and medical records to track how valsartan users responded to the crisis.
Dr. Mary Norine Walsh, a past president of the American College of Cardiology and a cardiologist at St. Vincent Heart Center of Indiana, said, "It's really interesting data, because my assumption would have been in Canada and the U.S. that substitution was made pretty much instantly."
That's what happened -- mostly.
Within one month, 85% of patients had a new prescription for an alternative to their generic valsartan, Jackevicius said. By three months, 90% had a prescription for a different blood pressure drug.
But that left 10% of patients with recalled valsartan who hadn't been prescribed an alternative, Jackevicius noted.
"Maybe they heard about the recall on the news and never went to their physician or clinician to get a substitution," Walsh said.
"When there's a recall like this, is there a patient lack of trust in the system? Do they not get back on drugs because they're afraid? I don't know," Walsh asked.
In the immediate aftermath of the recall, people swarmed Ontario emergency departments for blood pressure treatment, the researchers found.
Many of these folks likely were people who were afraid to take their valsartan and went to the ER for a replacement drug when they couldn't reach their doctor, Jackevicius suggested.
"That's not really the best place to go" when your drug is recalled, she said. "Going to the emergency department is not a good use of the resources there, and it's not a good use of the patient's time."
However, there were also probably quite a few who stopped taking the drug altogether and suffered symptoms related to high blood pressure, Jackevicius and Walsh said.
According to Walsh, "People did worse if they came off it, which is not surprising because the primary reason they were prescribed it was for hypertension."
Jackevicius said the incident revealed holes in medicine's response to major drug recalls.
Empowering pharmacists to reach out to patients and prescribe alternatives could be one way to improve the response to a recall, Jackevicius said.
Pharmacists have direct knowledge of the specific drugs handed out to patients that their doctors don't, she explained.
"It would make sense that they take more responsibility and be given the authority to substitute common medications, to be a point person in the event of a recall," Jackevicius said. "They are accessible and would know similar medications that might be OK for that condition."
Public health officials also could help by promptly creating a consensus list of approved alternative medications, so doctors and pharmacists could quickly and efficiently move patients onto a new prescription, she added.
Jackevicius presented her study last weekend at the American Heart Association's annual meeting, in Philadelphia. The work was also published recently in the journal Circulation.