I don't have access to real-time data or recent updates. However, I can provide some information on why the FDA may not have approved modafinil and armodafinil for ADHD use based on the information available up to that point.
The FDA's decision on whether to approve a medication for a specific condition is based on a thorough evaluation of clinical trial data, safety profiles, and efficacy in treating the targeted condition. While the potential risk of Stevens-Johnson syndrome or other skin rashes may be a concern, it is not the only factor that the FDA considers when evaluating drugs for ADHD.
The FDA evaluates various aspects before approving medications for ADHD, including:
Clinical trials in ADHD: The FDA reviews data from well-designed clinical trials that specifically assess the effectiveness and safety of the medication in children with ADHD. These trials must demonstrate a significant benefit over placebo with an acceptable safety profile.
Risk-benefit analysis: The FDA considers the overall risk-benefit profile of the medication for the intended use. If the benefits outweigh the risks, the medication may be approved.
Adverse events and safety concerns: The FDA thoroughly assesses all potential side effects and safety concerns associated with the medication, including severe adverse reactions like Stevens-Johnson syndrome. If the safety concerns are significant and outweigh the benefits, approval may be denied.
Comparison to existing treatments: The FDA considers whether the medication offers any advantages over existing treatments for ADHD in terms of efficacy, safety, or tolerability.
Dosing and administration: The FDA evaluates dosing and administration guidelines to ensure the medication can be safely and effectively used in the target population.
It's worth noting that the FDA's decisions are not always final, and additional data or further research may lead to reevaluations or changes in approvals in the future. Also, regulations and approvals might differ in various countries, so it's essential to consider specific regional contexts.
If you are curious about the current status of modafinil and armodafinil for ADHD treatment, I recommend checking the most recent information from the FDA or consulting a healthcare professional for the latest updates.