Article: FDA requires Accutane Med Guide.(Food and Drug Administration approves Hoffman-LaRoche Inc. medication guide)(Brief Article)

Article: Accutane Med Guide promised at Hill ...
Medical Marketing & Media;  February 1, 2001 ;     642 words ...The FDA promised at a December congressional hearing to require Hoffmann-La Roche to prepare a patient Med Guide and a new consent form within six months that warns of possible psychiatric side effects for its acne drug Accutane (isotretinoin ...

Article: FDA creates medication guide for Lariam.
M2 Presswire;  July 10, 2003 ;     700+ words ... ... 10 July 2003-US FDA: FDA creates medication guide for Lariam(C)1994-2003 M2 COMMUNICATIONS ... today announced the development of a Medication Guide (FDA-approved patient labeling ... psychiatric adverse events. "The Lariam Medication Guide is an important new tool for managing ...

Article: FDA Creates Medication Guide for Lotronex.(U.S. ...
Medical Letter on the CDC & FDA;  September 17, 2000 ;     700+ words ... ... FDA) announced the development of a Medication Guide (FDA-approved patient labeling ... according to the instructions in the Medication Guide, which reflect the revised professional ... information about a drug through a Medication Guide to patients, as well as updating ...

Article: FDA approves updated labeling with boxed warning and ...
M2 Presswire;  January 20, 2006 ;     700+ words ... ... updated labeling with boxed warning and medication guide for two eczema drugs, elidel and ... about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling ... updated with a boxed warning and a Medication Guide about the possible cancer risk for ...

Article: FDA APPROVES UPDATED LABELING WITH BOXED WARNING, ...
US Fed News Service, Including US State News;  January 19, 2006 ;     700+ words ... ... about a possible risk of cancer and a Medication Guide (FDA-approved patient labeling ... updated with a boxed warning and a Medication Guide about the possible cancer risk for ... within the six weeks of treatment. The Medication Guide will provide consumer friendly information ...

Article: Roche to Distribute New Medication Guide, Informed ...
Dermatology Nursing;  April 1, 2001 ;     700+ words ... ... prescription is issued, and a new Medication Guide that will be given to patients at ... including psychiatric events. The Medication Guide (MedGuide) for Accutane is a document ... FDA in discussions with Roche, the Medication Guide reinforces key safety issues that ...

Article: Panels discourage black box warning on AEDs; Antiepileptic drug ...
Clinical Psychiatry News;  August 1, 2008 ;     700+ words ... ... voted that patients should receive a medication guide describing the finding with each AED ... patients. He said he hoped that a medication guide would encourage physicians to discuss ... section of the label, and in a patient medication guide. The AEDs in the meta-analysis ...