Black Box Warnings - What do They Mean For My Child? 

A summary of the drug's chemical description, how it works, how it interacts with other drugs, supplements, foods, and beverages, what condition(s) it treats, who should not use the drug, potential serious side effects, commonly occurring side effects, and the effects on children, pregnant women, and the elderly is provided by the pharmacy with your prescription. Complete details of this information, including evidence from clinical trials and other essential data that health care professionals use to determine whether the drug is being prescribed appropriately for your child are found in the prescribing information. This information is also known as product labeling, or the package insert. Biologic products are also dispensed with printed information.

 

Some drugs and biologic products carry a Black Box Warning, which is the strongest warning issued by the Food and Drug Administration (FDA). The text of the warning is surrounded by a black border and appears on the label of the drug, the package insert, and other literature that describes the medication. The black border is the reason for the name, Black Box Warning.

 

Just because a drug or biologic product has a Black Box Warning does not mean it cannot be safely used in your child

 

There are two main reasons for this type of advisory: the medication can cause dangerous side effects as compared to the benefit from the drug and a serious adverse reaction can be prevented or reduced in seriousness if the medication is used properly. Of note, Black Box Warnings may affect a drug that has been designed to be given by mouth and intravenously, but NOT as eye drops. An example of this is found in the antibiotic class, the fluoroquinolones. BlackBoxRx.com is a free website that provides a list of all the drugs that contain a Black Box Warning.

 

Selected medications with a Black Box Warning may be required by the FDA to distribute a Medication Guide with the prescription to the patient. The Guide contains information approved by the FDA to help avoid serious adverse events and to help the parent make an informed decision about a known serious side effect with the drug. The Guide also urges adherence to directions when using the medication for it to work best. Medication Guides should be provided by the pharmacy when your child's prescription is dispensed and can also be obtained online at the FDA's website.