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For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user—the person who will take the ...
In July 2013, the FDA issued a boxed warning for the antimalarial drug mefloquine, noting the drug's adverse neuropsychiatric side effects, and emphasizing neurological effects from the drug could "occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent". [23]
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Internet pharmacies mail the prescribed drugs to the customer; boxes or mailing envelopes are used. Child resistant packaging is often required on the unit packs; if requested, a pharmacist is allowed put drugs in a bottle with easy open features. Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets.
The ability to prescribe drugs for uses beyond the officially approved indications is commonly used to good effect by healthcare providers. For example, methotrexate is commonly used off-label because its immunomodulatory effects relieve various disorders. [2] However, off-label use can entail health risks and differences in legal liability.
(Reuters) -A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly’s blockbuster weight loss and diabetes drugs off its list of ...
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.
A consumer advocacy group is urging the Food and Drug administration to immediately remove the weight-loss drugs Alli and Xenical from the market due to serious health concerns, including liver ...