Advertisment

Understanding FDA Drug Approvals and Navigating Related Side Effects

author-image
Ayanna Amadi
New Update
Understanding FDA Drug Approvals and Navigating Related Side Effects

Understanding FDA Drug Approvals and Navigating Related Side Effects

Advertisment

When it comes to drugs approved by the U.S. Food and Drug Administration (FDA), the benefits must outweigh the known risks. This is a critical requirement for any drug to receive FDA approval. However, this does not eliminate the possibility of side effects. Patients, healthcare providers, and consumers need to be aware of these potential side effects and understand how to manage and reduce associated risks.

Advertisment

Knowing the Side Effects

Finding detailed information about drug side effects is made easier thanks to resources like the FDA's MedWatch program. This program serves as a safety reporting platform for health professionals, patients, and consumers. It collects reports from the public and publishes safety alerts for FDA-regulated products. In addition to drugs, the program also covers reporting pathways for tobacco products, vaccines, and animal drug and device products.

Case Studies: Eflornithine and Nexletol

Advertisment

To illustrate, let's look at a couple of recently approved drugs. The FDA approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior therapy. The most commonly reported adverse reactions in the study of eflornithine included otitis media, diarrhea, and cough. This drug's approval was expedited due to its priority review, breakthrough designation, and orphan drug designation. Serious adverse events can be reported to the FDA's MedWatch Reporting System.

Another example is the updated LDL cholesterol-lowering indication for Nexletol and Nexlizet. These drugs are now approved for the treatment of primary hyperlipidemia. The most common adverse reactions in clinical trials were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain, and elevated liver enzymes. The CLEAR Outcomes trial demonstrated that bempedoic acid contained in both Nexletol and Nexlizet can significantly reduce cardiovascular risk.

Reducing the Risks

Advertisment

To reduce the risk associated with drug side effects, it is important to keep track of any changes in health after starting a new medication. Report any serious or unexpected side effects to your healthcare provider immediately. Furthermore, it is advisable to report these adverse events to the FDA's MedWatch Reporting System. This helps the FDA monitor the safety of approved drugs and take necessary actions if any new risks are identified.

Conclusion

While FDA-approved drugs undergo rigorous testing and review, side effects are a possibility. Being aware of these potential side effects and knowing how to manage them is a crucial part of responsible medication use. By staying informed and vigilant, patients and healthcare providers can work together to ensure the safe and effective use of these drugs.

Side Effects
Advertisment
Chat with Dr. Medriva !