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How Doctors View and Use Boxed Warnings on Drug Labels?
(Thursday, September 12, 2024) Many drugs are approved with a boxed warning (BW) on their labels assuming that the prescribers and patients would make informed decisions about using these drugs. But how effective are they in this purpose? An FDA study to evaluate BW in prescription practices yielded interesting but unsurprising findings. A BW highlights serious risks associated with a medicine. These warnings are used when the information available at the time of approval of a given drug indicates certain risks that could not be fully addressed in clinical trials. A BW is intended to warn the prescribers of potentially serious risks to the patients if improperly used or in certain populations. Many BW are accompanied by post-market commitments and pharmacovigilance requirements. However, not much is known about how BWs affect doctors' decisions or how patients use medicines with a BW. To better understand this, the researchers at the Center for Drugs at the FDA (CDER) conducted a study to evaluate how healthcare providers (HCPs) use BWs when making treatment decisions and how they talk to patients about these warnings. They looked at two medicines: one for treating hepatitis C (HCV), a life-threatening condition, and another for treating vulvovaginal atrophy (VVA), a less serious condition. Both medicines had a BW, but the warnings were different. The HCV warning was shorter and mentioned one risk, while the VVA warning was longer and listed several risks. The research team interviewed 52 HCPs, split evenly between those treating HCV and those treating VVA. These interviews explored how doctors thought about the medicine’s benefits and risks, how the BW affected their thinking, and how they discussed these risks with patients. The interviews revealed that doctors had mixed views on the usefulness of BWs. Some doctors, especially those with more experience, were already familiar with the risks and found the BWs less helpful. Perceptions of the BW also depended on the treatment scenario. For example, many doctors treating VVA felt that the BW overstated the risks, while those treating HCV found the BW more appropriate and important. The study also found that BWs are just one of many factors that influence a doctor’s decision to prescribe a medicine. Other factors, like a patient’s insurance, health history, and likelihood to follow through with treatment, played a big role. Doctors in both scenarios talked to their patients about the risks and benefits of the medicine and tailored their conversations to the patient’s individual situation. In the VVA scenario, doctors emphasized that the medicine, which is inserted vaginally, contains a lower dose of estrogen than oral estrogen medications, which they believed reduced the risk of side effects. They also told patients to watch for unusual side effects and contact them if needed. In the HCV scenario, doctors focused on the medicine’s high effectiveness and the importance of sticking to the treatment to avoid serious health problems like liver cancer. In conclusion, BWs are useful for alerting doctors to serious risks, but they are only one part of the decision-making process. How much a BW influences a doctor’s decision depends on the specific medical condition and other factors related to the patient. This study shows that doctors take a careful and individualized approach when considering BWs and communicating risks to patients. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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