drug products containing acetaminophen may cause severe skin reactions

drug products containing acetaminophen may cause severe skin reactions



FDA is issuing this proposed administrative order to amend the requirements for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter (OTC) human use, as currently described in Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (OTC Monograph M013).

This proposed order, if finalized, will amend OTC Monograph M013 to require the addition of a warning to the labeling of OTC internal analgesic, antipyretic, and antirheumatic drug products containing acetaminophen. The warning would alert consumers that the use of acetaminophen may cause severe skin reactions.

You may submit comments for Proposed Administrative Order OTC000035 electronically in OTC Monographs@FDA beginning on June 14, 2024.  See the Proposed Administrative Order for instructions. The Scientific Review Supporting Proposed Administrative Order OTC000035 can be viewed under the Supporting Documents.

One Response

  1. I’d love to know what kind of skin reactions. I take far more tylenol than I’d like to, since I can’t get a remotely reasonable level of pain relief for my many sources of chronic pain, including CRPS & AIP (acute intermittent porphyria, a genetic condition that can cause ANY symptom & does cause massive pain issues. But the last year or so, I’ve developed horrendous bumps/blisters on my back that itch so badly my sheets & shirts are all blood-spotted. No idea what the cause is, & just quitting tylenol completely would result in me being even more disabled than I already am –i wouldn’t even be able to change those blood-spotted sheets. I hate the frigging, stupid, anti-fact, DEA-controlled medical policies in this country. and I already have to spend more than I literally can to get the treatments to keep the AIP under control; without those treatments, I’ll be dead within 2 years, max. I’m just trying to survive long enough to let my service dog live out the rest of his life. He deserves it, even if this country clearly believes I don’t.

Leave a Reply

Discover more from PHARMACIST STEVE

Subscribe now to keep reading and get access to the full archive.

Continue reading