The MedWatch December 2011 Safety Labeling Changes posting includes 40 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The “Summary Page” available via the following link provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm284231.htm
Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.
The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:
- Multaq (dronedarone hydrochloride) tablets
- Dilantin-125 (phenytoin) Oral Suspension
- Norvir (ritonavir) Soft Gel Capsules, Oral Solution and Tablets
- Relenza (zanamivir) inhalation powder
- Tyzeka (telbivudine) tablets and oral solution
- Capoten (captopril) Tablets
- Danocrine brand of Danazol capsules
- Desferal (deferoxamine mesylate) for injection
- Edarbi (azilsartan medoxomil) Tablets
- Eloxatin (oxaliplatin) for intravenous use
- Heparin Sodium Injection
- Isentress (raltegravir) scored, chewable tablets, film-coated tablet
- Keppra (levetiracetam) Tablets and oral solution
- Onglyza (saxagliptin) tablets
- Ovide (malathion) 0.5% lotion1
- PegIntron (Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
- Plavix (clopidogrel bisulfate) tablets
- Remeron (mirtazapine) tablets and RemeronSolTab (mirtazapine) Orally Disintegrating
- Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules
While it is good that updates are provided for the above drugs, and all the others that are updated each month, The Health Gazette continues to warn people to only take medication that is really essential and if necessary seek further opinions when drugs are prescribed without sufficient explanation to justify their ‘essential’ status. ALL drugs are dangerous. The above revision approach is simply a demonstration that not enough is known about drugs that become FDA Approved, or for that matter, “approved” in any jurisdiction, and everyone who consumes prescribed drugs becomes little more than a ‘guinea pig’ in a large and poorly controlled drug trial.
Tags: MedWatch