CHPA is writing to request that FDA exercise its enforcement discretion and not take enforcement action against companies choosing to include a warning related to pregnancy on monograph product labels.
The results of nearly all recent observational studies of patients from around the world diagnosed with COVID-19 show no association between exposure to NSAIDs (including ibuprofen) and worsening clinical outcomes.
The Consumer Healthcare Products Association today issued the following statement in response to the Food and Drug Administration’s Drug Safety Communication on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).
In considering the safety of NSAIDs, the use of OTC NSAIDs should be clearly distinguished from long-term prescription NSAID use. OTC medicines have a different overall benefit-to-risk equation and a wider margin of safety than prescription NSAIDs.
Find frequently asked questions about OTC oral pain relievers and fever reducers including acetaminophen, aspirin, ibuprofen, ketoprofen, and naproxen sodium.
