UB team helping develop ground rules for use of newly approved drugs

Mar 8, 2021

The U.S. Food and Drug Administration receives many complaints about problems with drugs and medical devices. A team from the University at Buffalo has been assigned the task of figuring out which of these complaints are a serious health risk.

The goal is to develop computer algorithms that pull out adverse events from lots of complaints and make things safer for the public. Biostatistics Professor Marianthi Markatou said this has to start with the ingredients of a medicine.

"Before they get approved, they are listed in their ingredients of the drug and everything is listed there. The composition is listed and also what is listed is if there are minor adverse incidents, like headaches or, for example, fatigue," Markatou said.

It is called pharmacovigilance. Markatou said this is important because, although no problem may turn out in routine testing before a drug or device is approved for use, serious problems can turn up when it is used by the far larger general population.

This is even more important when tens of millions of people are receiving the new COVID vaccines. Could a user be allergic? Is it safe for pregnant women? If a problem develops, will it be life-threatening or mild?

The history of medicine is filled with glitches, including early problems with the polio vaccine, difficulties with the vaccine for H1N1 and a measles vaccine that didn't work very well for one year for reasons that aren't clear.