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Reporting can be conducted online, [3] by phone, or by submitting the MedWatch 3500 form by mail or fax. In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers. [4] The MedWatch system is intended to detect safety hazard signals for medical products.
Strong safety signals of bicalutamide with interstitial lung disease have been observed in pharmacovigilance databases such as the FAERS and Japanese Adverse Drug Event Report (JADER) databases (e.g., ROR Tooltip reporting odds ratio = 9.2, 95% CI Tooltip confidence interval = 7.9–10.6; ROR = 8.2, 95% CI = 6.0–11.2).
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
Due to the program's open and accessible design and its allowance of unverified reports, incomplete VAERS data is often used in false claims regarding vaccine safety. [14] [15] [16] The Centers for Disease Control and Prevention (CDC) has warned that raw data from VAERS is not enough to determine whether a vaccine can cause a particular adverse ...
All signals deemed worthy of investigation, require further analysis using all available data in an attempt to confirm or refute the signal. If the analysis is inconclusive, additional data may be needed such as a post-marketing observational trial. Signal detection is an essential part of drug use and safety surveillance.
A medical alarm [1] is an alarm system designed to signal the presence of a hazard requiring urgent attention and to summon emergency medical personnel. Other terms for a medical alarm are Personal Emergency Response System (PERS) or medical alert. It is especially important to recognize the need to respond to situations where the person is ...