According to the Food and Drug Administration, generic medications make up 80 percent of total drug prescriptions dispensed in the U.S. But what if the generics are not of the same standard?
One University of Florida study is researching the effectiveness between the brand and two generic versions of a widely-used medication for managing high blood pressure, metoprolol extended-release (ER). The medication was called into question after numerous reports were sent to the FDA reporting inconsistent effects when individuals switched from the brand name to a generic formulation.
The study, named “Open-Labeled Pharmacokinetic and Pharmacodynamic (PK-PD) Studies of Metoprolol ER”, involves a collaborative team from the UF College of Medicine, UF College of Pharmacy and the UF Clinical and Translational Science Institute. The team that includes lead principal investigator Larisa Cavallari, PharmD, co-investigator Siegfried Schmidt, MD, PhD and research fellow Scott Mosley, PharmD.
“HealthStreet has helped increase our subject recruitment by explaining the purpose of our study to interested members of the community,” Scott Mosley, PharmD.
According to Mosley, the study was prompted after numerous reports were sent by patients and doctors to the FDA reporting inconsistent effects when individuals switched from the brand name to a generic formulation or when switching from one generic to another.
“Problems with bioequivalence could have serious and widespread consequences given the high frequency of metoprolol ER use in the management of various cardiovascular disorders including hypertension, coronary heart disease, heart failure and cardiac arrhythmias,” he said.
Mosley said that these ongoing regulatory issues point to a need to further investigate if any differences truly exist between the brand and generic metoprolol products.
“This research is important because high blood pressure affects millions of people and this study will help ensure that patients are being provided high quality generic options.”
Mosley said that the objective of the study is to collect data to ensure that the generic alternatives to metoprolol products are of high quality by establishing criteria for manufacturers to follow.
Although the study is still in progress, Mosley acknowledges that HealthStreet is playing an important role in the community’s awareness of the study. “HealthStreet has helped increase our subject recruitment by explaining the purpose of our study to interested members of the community.”