If Aspirin Were Discovered Today, Would The FDA Approve It?

Consider the known side effects for aspirin, and then wonder whether the FDA would approve the drug had it been invented today.

The aspirin side effects include, but are not limited to:

stomach pain, heartburn, nausea and/or vomiting, as well as increased rates of gross gastrointestinal bleeding.

.

A.G. Bayer, which discovered and first sold the little white pills notes:

While the most common side effects associated with aspirin use are GI related, the majority of these are minor and resolve without medical intervention. In rare cases, more serious effects, such as bleeding, have been observed in individuals taking aspirin for extended periods of time. Even less commonly, hemorrhagic stroke can occur. However, the benefits of treatment have been shown usually to outweigh the risks in cases of long-term use to help prevent cardiovascular events in people at elevated risk for CVD (with FDA recommended doses ranging from 75-325 mg for MI and 50 mg – 325 mg for recurrent stroke)

Or, note the interactions between aspirin and other medications or conditions:

Aspirin should be avoided by patients with peptic ulcer disease or poor kidney function, since this medication can aggravate both conditions. Aspirin is avoided in patients taking blood thinning medications (anticoagulants) such as warfarin (Coumadin), because of an increased risk of bleeding. Some asthma patients can have worsening of breathing while taking aspirin. Aspirin can alter the blood uric acid level and is avoided in patients with hyperuricemia and gout. Children and teenagers should avoid aspirin for flu or chickenpox symptoms because of the associated risk of Reye's Syndrome, a serious disease of the liver and nervous system that can lead to coma. Aspirin is not habit forming. Aspirin can increase the effect of medicines used to treat diabetes mellitus, resulting in abnormally low blood sugars if not monitored. NSAIDs should be discontinued prior to elective surgery because of a mild tendency to interfere with blood clotting. Aspirin is best discontinued at least ten to fourteen days in advance of the procedure.

With all the problems associated with aspirin, would I consider not taking it if needed? Absolutely not.

All medications pose risks, and those risks are generally associated with the dosage and period of use. If there are safer alternatives, then those should be administered, but when a drug can provide a significant improvement in health and wellbeing, the potential of side effects must be weighed against the benefits.

This should all be kept in mind when taking any medication, including Bextra, Vioxx, or aspirin.