AbbVie Inc. and other drugmakers might have to do more testing of their testosterone replacement drugs.
An advisory panel has recommended the U.S. Food and Drug Administration require more tests of the heart risks of testosterone replacement therapies. North Chicago-based AbbVie makes Androgel, the biggest seller among the group.
The panel of experts on Wednesday also voted in favor of narrowing the use of testosterone replacement, possibly excluding millions of men from using the drugs.
“Testosterone replacement therapy is an important men’s health topic. AbbVie is committed to our patients and we will work with the FDA during its review,” AbbVie said in a statement.
Use of testosterone products from AbbVie Inc., Eli Lilly & Co. and others almost doubled in 2013 from 2010. About 20 percent of patients on the treatments don’t have laboratory evidence showing they need them, according to an analysis of data that FDA staff members called “particularly concerning,” Bloomberg reported.
The FDA is not required to follow the panel’s recommendation and there is no deadline for it to decide.
In July, Health Canada warned doctors a “growing body of evidence” suggests the drugs may increase the risk of heart attack, stroke, blood clots and irregular heart rate, The Associated Press reported.