Search results
Results from the WOW.Com Content Network
Some side effects, such as weight gain, occur more frequently with certain types of antidepressant medication. Switching to a new type of antidepressant may help reverse any weight gain you’ve ...
A risk management plan is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or ...
This article needs more reliable medical references for verification or relies too heavily on primary sources, specifically: Unsourced list of side effects, needs references. Please review the contents of the article and add the appropriate references if you can. Unsourced or poorly sourced material may be challenged and removed
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.
Unlike direct side effects, an adverse event does not necessarily mean the medication directly caused the problem. These events can include any unfavorable symptoms, signs , or medical conditions that appear during medical treatment, regardless of whether they are definitively linked to the specific medication being studied.
Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
The MedWatch system collects reports of adverse reactions and quality problems of drugs and medical devices but also for other FDA-regulated products (such as dietary supplements, cosmetics, medical foods, and infant formulas). As of the summer of 2011, the program had received more than 40,000 adverse event reports.
Research suggests that these events are often inadequately reported in publicly available reports. [4] Because of the lack of these data and uncertainty about methods for synthesising them, individuals conducting systematic reviews and meta-analyses of therapeutic interventions often unknowingly overemphasise health benefit. [5]