How Common Are Drug Recalls?

We all applaud the numerous life-saving medications that help many people enjoy a higher quality of life than they may have experienced without these wonder drugs. In the US, the FDA is in charge of approving the medications that come to market in our country and ensuring they are safe and effective. 

While each new prescription drug is carefully looked at by the experts at the FDA before it is granted approval, over the last ten years statistics show there were more than 14,000 drugs recalled. This adds up to an average of almost four recalls a day.  

Experts say although the numbers sound alarming, in most cases, the FDA is aware of any side effects and risks the drug has before it is made available to the public. According to an article from the Harvard Medical School, there are several explanations as to why things are missed after approval, and a drug is deemed unsafe and recalled.

The most likely reason is drug clinical trials are typically done with at most a couple of thousand people. After a drug is widely used by tens of thousands, rare reactions may turn up. Secondly, clinical trial participants are generally healthy in order to produce better trial results. Once the general public is using the drug, it may not work like it did during trials. Problems can also crop up because people are using other medications as well.

Other complications resulting in a drug being recalled include poor manufacturing processes including bacterial contamination or problems with mislabeling and storage. In some cases, incidences of recalls are due to manufacturers adding additional ingredients that were never in the original medication. 

Thankfully most recalls are not life-threatening or dangerous to the user. Only 6 percent of recalls are Class I. This is where the drug is deemed dangerous and poses a serious health risk. The majority of recalls fall into the Class II category where a drug may present a less serious health risk or a temporary one. Many times it is a matter of a drug being improperly stored such as a too hot location.  

To safeguard yourself, you can sign up for texts or emails from the FDA regarding safety alerts and recalls on drugs. Additionally, pharmacists advise patients to carefully examine their new prescription for the correct color and broken or crumbling pills. Contact your healthcare provider if you have any concerns regarding your medications. 

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Source:health.harvard.edu/blog/drug-recalls-are-common-202303292907