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Related Concept Videos

Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion01:20

Pharmacokinetics in Obese Patients: Drug Metabolism and Excretion

Drug metabolism, a critical process in the liver, involves two primary phases: Phase I reactions and Phase II conjugation. Obesity introduces significant alterations in this metabolic process, primarily due to fatty infiltration of the liver, leading to conditions such as nonalcoholic fatty liver disease (NAFLD). This condition can modify the activities of both Phase I and II enzymes, impacting how drugs are metabolized in obese patients.Phase I metabolism sees variable effects across...
Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Pharmacokinetics in Obese Patients: Drug Absorption and Distribution01:25

Pharmacokinetics in Obese Patients: Drug Absorption and Distribution

Obesity significantly alters the pharmacokinetic processes of drug absorption and distribution, presenting unique challenges in medical treatment. The increased fat tissue and decreased lean muscle in obese individuals can significantly affect how drugs are absorbed into the body and distributed across different tissues. This alteration can lead to variances in the effectiveness and safety of medications, necessitating adjustments in dosing or drug selection for obese patients.One notable...
Drug Dosing: Obese Patients01:21

Drug Dosing: Obese Patients

In the United States, obesity is a prominent concern. It is linked to heightened mortality rates due to increased occurrences of conditions such as hypertension, atherosclerosis, coronary artery disease, and diabetes compared to nonobese individuals. A patient is classified as obese if their actual body weight surpasses the ideal or desirable body weight by 20%, based on Metropolitan Life Insurance Company data. Ideal body weights consider average weights and heights for males and females...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

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Related Experiment Video

Updated: Jul 5, 2026

Co-Translational Insertion of Membrane Proteins into Preformed Nanodiscs
08:24

Co-Translational Insertion of Membrane Proteins into Preformed Nanodiscs

Published on: November 19, 2020

Orlistat F Hoffmann-La Roche Ltd.

M Malone1

  • 1Albany College of Pharmacy, 106 New Scotland Avenue, Albany, NY 12208, USA. malonem@panther.acp.edu

Idrugs : the Investigational Drugs Journal
|May 10, 2008
PubMed
Summary

Orlistat, an obesity drug, showed efficacy but raised concerns regarding a statistically significant increased risk of breast cancer in clinical trials. Further studies are required to confirm safety and finalize regulatory approvals.

Area of Science:

  • Pharmacology
  • Oncology
  • Drug Development

Background:

  • Orlistat (Xenical) is a lipase inhibitor developed by Roche for obesity treatment.
  • It received approval in several countries and was under review by the US FDA and European Commission.

Purpose of the Study:

  • To evaluate the efficacy and safety of Orlistat for obesity treatment.
  • To address regulatory requirements for final approval, including safety data on breast cancer.

Main Methods:

  • Phase III clinical trials were conducted to assess Orlistat's effects.
  • Data analysis included efficacy, safety, and specific attention to breast neoplasm occurrences.

Main Results:

  • Orlistat demonstrated efficacy in obesity treatment.

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  • A statistically significant increased risk of breast cancer was observed in patients taking Orlistat compared to placebo.
  • The relative risk was estimated to be 5.9-fold greater, or 3.6-fold greater including follow-up.
  • Conclusions:

    • While Orlistat shows efficacy, further clinical trials are necessary to rule out links between the drug and breast cancer.
    • Regulatory approval was pending, contingent on further safety data and labeling agreements.