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Drug interactions
Published in Mervyn Dean, Juan-Diego Harris, Claud Regnard, Jo Hockley, Symptom Relief in Palliative Care, 2018
Mervyn Dean, Juan-Diego Harris, Claud Regnard, Jo Hockley
In the US, Med Watch is the FDA (Food and Drug Administration) safety information and adverse effect program. Any suspected drug interactions can be reported by telephone to 1–800-FDA-1088, or via www.fda.gov/medwatch/.
How Drugs Are Discovered, Tested, and Approved
Published in William N. Kelly, Pharmacy, 2018
To help monitor the serious adverse effects of drugs, the FDA has a reporting system called MedWatch. Serious ADRs are fatal, are life threatening, cause hospitalization, prolong hospitalization, or result in disability. ADRs are reported to the FDA by health-care personnel or patients through MedWatch. The FDA quickly puts all reports into a computer system and then searches for any significant patterns. There is a similar program for the reporting of serious ADRs for vaccines. This program is cosponsored by the FDA and the Centers for Disease Control and Prevention (CDC) and is called the Vaccine Adverse Event Reporting System (VAERS).
Key Dietary Supplements: Omega-3 Fatty Acids, Vitamin D, and Probiotics
Published in Hilary McClafferty, Integrative Pediatrics, 2017
Manufacturers of dietary supplements must register their facilities with the FDA and report all serious adverse events but are not required to get pre-market approval of their products. Strengthening of FDA safety regulations was introduced in 2007 in the form of Current Good Manufacturing Practices (CGMPs), which mandate that dietary supplements are processed, labeled and packaged in accordance with stricter guidelines (http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm079496.htm). This is a step forward and consumers should be counseled to look for the GMP seal, but still be aware that this does not imply efficacy or safety. The FDA voluntary reporting system MedWatch is available for reporting concerns and adverse events, a helpful but reactive system. (http://www.fda.gov/Safety/MedWatch/default.htm)
Evaluation of the current data on guanfacine extended release for the treatment of ADHD in children and adolescents
Published in Expert Opinion on Pharmacotherapy, 2020
Ann Childress, Asmara Hoo-Cardiel, Peter Lang
More than 1000 subjects have participated in clinical trials for GXR. Efficacy and AEs are well characterized. MedWatch surveillance over the past decade has not yielded new safety concerns. In short-term trials, efficacy was less than that of stimulants, and subjects were more likely to discontinue GXR due to AEs than the stimulants [12,18,19,62]. However, GXR is appropriate for patients who do not tolerate AMPH or MPH, especially those who have significant decreased appetite, insomnia or tachycardia. The AAP guidelines recommend the use of an FDA-approved medication [9]. AACAP guidelines were published prior to the approval of GXR and therefore, do not address its use. The National Institute for Health Care and Excellence (NICE) recommends ATX or guanfacine use additionally as third line if patients have not responded to separate 6-week trials of MPH or lisdexamfetamine [63]. Long-term slowing of growth is a significant concern for many patients who are treated with stimulants [64,65]. GXR may also be a preferred treatment if there are concerns about ongoing stimulant abuse in the patient or a family member living with the patient. Another major advantage of GXR is that dosing can occur at any time of the day.
Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)
Published in Expert Opinion on Drug Safety, 2019
Shahariar Mohammed Fahim, Ahmed Ullah Mishuk, Ning Cheng, Richard Hansen, Angela I. Calderón, Jingjing Qian
The FAERS is a database including spontaneous AE reports submitted to the U.S. Food and Drug Administration (FDA). This database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. FDA receives voluntary reports from health-care professionals and consumers through the FDA MedWatch program [13]. The majority of reports in FAERS are submitted by pharmaceutical manufacturers, as required by FDA regulations [14]. A detailed description of FAERS is available online [14]. This study utilized the public release of the FAERS data from January 2004 through December 2015. Further, duplicate reports were deleted from the database prior to conducting analyses. This study was reviewed and approved by Auburn University Institutional Review Board.
The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database
Published in Expert Opinion on Drug Safety, 2018
Oluwadolapo D. Lawal, Maitreyee Mohanty, Harrison Elder, Margie Skeer, Nathalie Erpelding, Ryan Lanier, Nathaniel Katz
Individual files containing master event, device, patient, and text data for 2011–2016 were downloaded from the MAUDE database on 14 September 2016. Device-related events involving IV-PCA occurring in hospitals constituted events of interest and thus the unit of analysis. PCA-related events were identified using the product code ‘MEA,’ which represents ‘infusion pump’ or ‘PCA,’ as described by the product code classification database [33]. Each event was potentially associated with multiple reports, e.g. an initial report and follow-up submissions. Therefore, multiple reports of the same event were linked to form a single line item using a unique identifier (the MDR report key) for each report. MEDWATCH forms record both the date of each event and the date of the report for each event submitted to MAUDE. In this study, the date of the report was used to identify events reported between 1 January 2011 and 12 September 2016, as this field was more consistently populated than the date of event field.