Testing the usefulness of the number needed to treat to be harmed (NNTH) in benefit-risk evaluations: case study with medicines withdrawn from the European market due to safety reasons.

The Importance of Number Needed to Treat to Be Harmed (NNTH) in Drug Safety Evaluations

In the vast desert of drug development, we're always striving to find the perfect oasis of safety and efficacy. But sometimes, even after careful evaluation, a drug might turn out to be more of a mirage than a life-saving solution. This research delves into the crucial role of the number needed to treat to be harmed (NNTH) in benefit-risk assessments, particularly when it comes to medicines withdrawn from the European market due to safety concerns.

The study employed a meta-analysis approach, pooling odds ratios (OR) from longitudinal studies to calculate NNTH values for various adverse events. The results revealed a striking trend: NNTH values tended to decrease from pre-marketing to post-marketing phases for most of the medicines analyzed. For example, the NNTH for developing peripheral neuropathy with almitrine increased from infinity (pre-marketing) to 12 (post-marketing), highlighting the critical importance of continued surveillance even after drug approval.

NNTH: A Guiding Light in the Desert of Drug Safety

This study underlines the immense value of NNTH in making informed decisions about drug safety. By providing a clear and concise measure of the risk of harm associated with a drug, NNTH can serve as a valuable compass for regulators and healthcare professionals alike.

Navigating the Sands of Drug Safety

The findings suggest that NNTH has the potential to be a powerful tool in benefit-risk re-evaluations of medicines, assisting regulators in making informed decisions about drug safety. While the desert of drug development can be vast and unforgiving, NNTH can provide a valuable oasis of insight, helping us to navigate the complex landscape of drug safety and optimize patient well-being.

Dr.Camel's Conclusion

This study sheds light on the importance of monitoring drug safety even after a medicine has been approved. The NNTH, much like a trusty camel in the desert, helps us assess the potential risks of a drug, allowing us to make informed decisions to protect patient health and minimize harm.