In the past few months, consumers have seen several major recalls of common medications from the U.S. Food and Drug Administration (FDA). From the valsartan recall back in July to the latest announcement of a birth control medication, Ortho-Novum recalled for faulty instructions, these drug recalls are becoming commonplace in our news headlines. Though however frequently, we might see these news stories come up, for many consumers, a drug recall still incites a sense of fear and uncertainty. To reduce this anxiety around drug recalls, here are the basics to understand why a drug might be recalled and how you should safely react to a recall.
Why might a drug be recalled?
There are several main reasons that a drug could be recalled. The contamination of a drug or one of its ingredients is grounds for a recall. This was the reason behind the valsartan recall this past summer and the recent losartan recall. In both cases, a probably human carcinogenic impurity was identified in the drugs’ ingredients. If the packaging or labeling of a drug is misleading enough to cause a user error, the FDA might issue a recall like the one for Ortho-Novum. A drug may also be recalled if it has been mislabeled, if a manufacturing issue has affected the quality of the drug, or if the drug poses a health serious health risk to patients.
How should you react to a drug recall?
For the more severe drug recalls, patients taking the affected medication will be notified directly by the FDA, the manufacturer, or their local pharmacist with information on how to proceed safely. If, however, you hear about a recall of a medication you are taking and you have not received notice, you can use the FDA’s website to confirm whether or not your medication was affected. Compare the company name, lot number, and National Drug Code (NDC) on your bottle with the FDA’s records.
Sometimes a certain batch of drugs will be recalled so not everyone taking the medication will be affected. The FDA’s website will also tell you the classification of the recall. A Class I recall is the most serious and poses the most risk to a patient’s health and safety. A Class III recall, on the other hand, poses the least risk to patients and is generally issued for an issue with the labeling or packaging.
Typically with a prescription medication that treats a serious health condition like high blood pressure, patients are recommended to remain taking the recalled medication unless otherwise instructed by their doctor. After determining that their medication was included in the recall, patients should consult their doctor immediately about alternative medications. Once, you have the new medication in hand, talk to your local pharmacist about the best way to dispose of your recalled medication.
If you are taking an over-the-counter (OTC) medication that has been recalled, you can usually take it back to the pharmacy or drug store where you bought and receive a refund or replacement. Once taking a replacement medication, regardless of whether its a prescription or OTC drug, it’s important to monitor your body closely for any unusual side effects to the new drug. Report these symptoms to your doctor as they occur.
What you can do as a consumer?
Recalls don’t just happen to consumers. Oftentimes, they are issued because of active consumers voicing their concerns about a drug or product. Every consumer has this opportunity to be heard, and the FDA wants the feedback. If you experience any adverse side effects while taking a medication or notice a defect in your prescriptions packaging or pill quality, you can report it directly to the FDA using their MedWatch reporting form here. You should also let your pharmacist or doctor know of the problem as well to remedy the situation quickly.
To get up-to-date information the FDA about recalled consumer drugs, subscribe to their MedWatch Safety Alerts today!
What are your rights?
If you have experienced severe harm or incurred large medical bills after treating adverse side effects caused by a recalled medication, you may have a valid legal case. Speak with an experienced lawyer to better understand your legal rights and the legal options available to you.
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