Some medications carry risks serious enough to require the FDA’s strongest safety warning: a black box warning. This type of boxed warning alerts healthcare providers and patients to the possibility of severe or life-threatening harm upon consumption.
That a drug has a boxed warning does not necessarily mean it is unsafe for every patient or that it is a medication error to prescribe it. It instead means that providers should carefully consider the stated risks on the box, follow any recommended precautions, and monitor the patient when required. Contact our Las Cruces medication error attorney if you need legal assistance today.
What Is a Black Box Warning?
A black box warning is a notice included in a medication’s prescribing information. The FDA may require such a warning when a drug presents a serious risk of complication that should be considered before prescribing or administering it.
Depending on the medication, the warning may address risks involving:
- Thoughts of suicide or harmful behavior
- Severe allergic reactions
- Damage to the organs
- Dangerous interactions with other medicines
- Pregnancy/ birth complications
- Serious infections
- Misuse or addiction
- Higher risk of death in certain patients
The warning may also identify groups of patients who should not receive the medication or explain the testing and monitoring required during treatment. Before prescribing the medication, a healthcare provider may need to review the patient’s medical history, current prescriptions, age, pregnancy status, and other risk factors.
How Can a Provider Fail to Address a Black Box Warning?
Claims involving boxed warnings can arise in several ways. Examples include:
- Prescribing medicine without checking the patient’s medical history
- Giving the drug to someone with a condition listed in the warning
- Ignoring potential dangerous interactions with other drugs
- Ordering a dose that violates the drug’s safety guidelines
- Failing to request required blood tests or routine health monitoring
- Keeping a patient on the drug after warning signs or side effects appear
- Failing to inform the patient about major risks or alternative treatments
- A pharmacy missing a harmful interaction between combined medications
In such cases, a patient’s injury after taking a medication with a boxed warning may be considered malpractice, specifically, if provider failed to act as a reasonably careful healthcare professional would have acted before prescribing/administering the drug.
How Do You Establish a Claim Involving a Boxed Warning?
Proving a medication error case usually means taking a close look at a patient’s medical records, prescription history, and the exact warning on the drug at the time. This helps show what the doctor knew about the risks of taking the drug and whether they took the right precautions before prescribing the medication.
Expert testimony may be necessary to explain:
- The standard of care that applied to the provider
- Whether the medication was appropriate for the patient
- What monitoring or testing should have occurred before providing the drug
- Whether the patient should have received additional warnings
- How the provider’s failure contributed to the injury
Even though a boxed warning can provide evidence of medical negligence, it doesn’t automatically establish your case on its own. You’ll still need to show that the healthcare provider’s actions directly caused your injury, usually with the assistance of a medical expert who can testify about how the provider violated accepted medical standards.
If you suffered a serious complication after receiving a medication with a boxed warning, Coates & Johnson determine whether you have a malpractice claim. Contact our medical malpractice lawyer in Las Cruces today for a free consultation.