A newly published study suggests the recent recalls involving valsartan and other contaminated blood pressure medications might have triggered a significant increase in emergency room visits.
The study, which was published this week in Circulation, utilized the Ontario Drug Benefit (ODB) prescription claims database to identify a cohort of valsartan users, as well as a cohort of non-users. Several other health databases from Ontario, Canada, were accessed to identify emergency room visits, discharge diagnoses for hospital admissions, baseline comorbidities, and clinical outcomes.
All of the datasets were linked using unique encoded identifiers and analyzed by researchers at the Institute for Clinical Evaluative Sciences. That analysis identified more than 55,400 patients, 65 years or older, who had been dispensed at least one recalled valsartan product that would cover the period up to and including the date of 7/9/2018, and who were alive on this date. Their average age was 76.
The vast majority of valsartan patients – 95% — were being treated for high blood pressure, while just 5% had heart failure. Nearly 11% did not replace their medication in the three months that followed the first valsartan recall announcement.
Prior to the recall, an average of .11% of the valsartan patients had made a trip to the emergency room in any given month. But just a month after the recalls began making news, the rate had jumped to .17%. The analysis also detected a 6% spike in emergency room visits for stroke patients taking valsartan, as well as an 8% jump in hospitalizations, but most of the increase did not occur until November.
“While government agencies issued advisories to continue taking medications until contacting their prescribers, there is a high potential for misunderstanding by patients, particularly given the mass media news that may have heightened the alarm regarding the potential negative consequences,” the study authors wrote.
“Patients may have been willing to risk the short-term potential of uncontrolled hypertension to avoid ingesting a potential carcinogen.”
Numerous generic drug makers around the world have recalled valsartan, irbesartan, and losartan-containing heart and blood pressure drugs since July 2018, when the first of three potentially cancer-causing nitrosamines was discovered in active ingredient manufactured by suppliers in China and India.
Nitrosamines are typically found in cured meats and can occur as a byproduct of the manufacturing process. The compounds are considered probable human carcinogens and have been linked to an increased risk of gastrointestinal, liver, and kidney tumors.
The U.S. Food & Drug Administration believes contaminated drugs resulted from a change in production methods instituted by overseas manufacturers roughly four years before the first valsartan recall. Thus, it’s likely that potentially carcinogenic medications had already been on the market for at least four years.
More than 140 valsartan lawsuits are now pending in a multidistrict litigation underway in New Jersey federal court. The claims include personal injury cases that blame contaminated drugs for causing cancer, as well as class action complaints that seek economic damages for consumers who purchased recalled valsartan products.
As many as 1.8 million Americans may have taken contaminated heart and blood pressure medications, suggesting the valsartan litigation could grow significantly larger. In fact, a lawyer for MSP Recovery, a Florida-based service representing health insurance companies that covered 73,311 valsartan patients prior to the recalls, recently estimated those claims were worth over $91 million.