FDA denies Bayer's request for labeling aspirin as primary preventative medicine for heart attack
POSTED: Tuesday, May 6, 2014 - 5:07pm
UPDATED: Wednesday, May 7, 2014 - 9:16am
Tyler Tx, (KETK) — The Food and Drug Administration shot down Bayer, the maker's of aspirin's request.They wanted to put labeling on their package saying their product prevents first time heart attacks. Bayer wants those who have no history of cardiovascular disease to take their medicine. But, the FDA said for those who are healthy, the risks of taking aspirin outweighs the benefits.
For years doctors have been recommending their patients to take aspirin to prevent a second heart attack.
"It's fundamentally important that for secondary prevention who have had a heart attack or heart disease or stroke, they need to be on aspirin or continue to take it," said Tyler CAET Dr. Scott Lieberman.
Doctors said the medicine reduces blood clots. Bayer was looking for permission to list aspirin as a primary preventative medicine for those who have never had cardiovascular disease. But, after a few studies, the FDA said there wasn't enough evidence to prove this.
"The main thing the FDA was saying is they're not comfortable putting on the bottle for the average consumer to pick it up and say this will prevent heart attacks," said Kinsey Pharmacist Brad Martin.
Doctors said there can be serious side effects with taking aspirin.
"It works to prevent clotting, which helps prevent heart attacks but in the same manner it's a blood thinner and it can cause side effects such as bleeding," said Martin.
"Taking aspirin may reduce the risk of having a heart attack and may increase the risk of gastro intestinal bleeding and it was felt the balance between the risk and the benefit for people that didn't have documented coronary disease was not strong enough to warn about taking aspirin," said Dr. Lieberman.
But doctors tell us since the 1970s, data has shown that people who had a heart attack, stroke or heart disease, taking a daily low dose of aspirin can help prevent them from having another one.
So you should listen, if your doctor recommends you take an aspirin.