Be Aware of Black Box Warnings
Every day many medications are prescribed for medical conditions, but did you know that some of those medications can include serious risks or warnings? Black box warnings, also called boxed warnings, are required by the U.S. Food and Drug Administration for certain medications that carry serious health safety concerns and can cause harm.
The Black Box Warnings are intended to call attention to serious risks or warnings about the medication. Some medications may have a black box warning if they have the potential to cause serious harm, hospitalization, or even death. The intention is for healthcare professionals to be aware and carefully consider risks vs. benefits when prescribing medications to patients. Srict monitoring should be considered when prescribing medications with black box warnings. This is something your healthcare provider should review with you before prescribing. Below is an example of how a black box warning will look and where you can find them.
If a medication you’re prescribed has a black box warning, that doesn’t always mean that you shouldn’t take it, but the risks and benefits of the medication is something your healthcare provider should review with you. In the Jama Network study covering 2001 to 2010 it was revealed that of the 222 drugs approved, manufacturers pulled 3 off the market. The FDA also required 61 black box warnings: that’s 28% of medications!
That’s a lot of medications with potential, serious side effects that could be affecting the public at large. For example, several kinds of combination birth control pills carry a black box warning related to cardiovascular risks associated with them. The warning also strongly advises that women who use them not smoke, as cigarette smoking is known to increase the risk of those side effects. Another medication widely prescribed is Depo Provera (medroxyprogesterone acetate), a birth control that is recommended to only be taken for maximum of two years, due to the risk of osteoporosis. Many women are prescribed Depo Provera, but they may not have been alerted to the black box warning. If you have been taking Depo Provera for several years talk to your physician about having a bone density scan. Check out this link for information on Depo Provera’s black box warning: pfizermedicalinformation.com/depo-provera.
Consider these examples for how wide-reaching medications with black box warnings can be.
It’s estimated that 1 in 7 Americans over age 70 have some form of dementia (news.umich.edu). Three atypical, antipsychotics: quetiapine (Seroquel), olanzapine (Zyprexa), and risperidone (Risperdal), which often treat elderly patients with dementia, were marked with black box warnings by the FDA in 2005. Why did it get the black box? Research stated that patients faced an increased risk of death.
Millions of Americans are diagnosed with epilepsy and that’s not counting singular cases of seizures (cdc.gov/epilepsy). In our field you may have come across Lamotrigine (Lamictal), an antiepileptic drug sometimes used to help people with epilepsy or bipolar disorder. But did you realize it too has a black box warning? This medication has been known to cause life-threatening serious rashes like Stevens-Johnson syndrome, toxic epidermal necrolysis, and rash-related death. Statistics showed more cases in children than adults. (“10 Black Box Warnings Every Pharmacist Should Know” PharmacyTimes.com)
All medications come with side effects or risks but those with Black Box Warnings can have more serious or life-threatening side effects and risks. Always talk to your healthcare professional or pharmacist about the medications being prescribed, especially any newly prescribed medications. For more information on medications and Black Box Warnings, visit blackboxrx.com. This alphabetical list includes all concerns with medications.
