Accutane

• FDA Accutane Medication Guide
• Accutane Label
• FDA Patient Information Sheet on Accutane

Avandia

• Avandia Label
• Avandia Dear Doctor Letter
• Avandia Dear Doctor Letter Information Correction
• Avandia: FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety

Baush & Lomb

• Baush & Lomb Litigation Information

Bextra

• FDA asks Pfizer to remove Bextra(R) from the Market
• Bextra FAQ
• Treatment of severe drug reactions Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis and Hypersensitivity syndrome

Celebrex

• Celebrex Label
• Celebrex Health Care Information Sheet
• Celebrex Patient Information Sheet
• FDA Statement on the Halting of a Clinical Trial of the Cox-2 Inhibitor Celebrex

Chantix

• Chantix Label
• Chantix FDA Newsletter

Crestor & Rhabdomylosis

• What is Crestor?
• Chantix: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
• Chantix: Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)

Effexor

• Effexor Label
• Effexor Dear Doctor Letter
• Effexor (warning against injuries to neonates): Effexor and Effexor XR (venlafaxine HCl)

Fen-Phen & PPH

• Have you been affected by PPH?
• Primary Pulmonary Hypertension

Fentanyl Patch

• Fentanyl Patch Label
• Fentanyl Patch Dear Doctor Letter
• Fentanyl patch: FDA Issues Second Safety Warning on Fentanyl Skin Patch: Deaths and serious injuries from improper use

Fosamax

• Fosamax Litigation Information
• Fosamax Label
• Fosamax (warning against osteonecrosis of the jaw): Fosamax Plus D (alendronate sodium/cholecalciferol) tablets

GBCA

• Magnevist Label
• Multihance Label
• Omniscan Label
• Optimark Label
• Prohance Label
• GBCAs Dear Doctor Letter

Gadolinium

• Gadolinium Litigation Information

Defective Medical Devices

• Defective Guidant Defibrillator Recall
• Knee Replacement Prostheses

Ketek

• Important Info About Ketek
• FDA Announces Label and Indication Changes for the Antibiotic Ketek
• Ketek Description and Warning
• Ketek Medication Guide
• Telithromycin (marketed as Ketek) Information
• FDA Public Health Advisory
• Questions and Answers on Telithromycin (marketed as Ketek)

Kugel

• Kugel Dear Doctor Letter
• Kugel Dear Hospital Administrator Letter
Kugel recall http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm062944.htm

Levaquin

• Levaquin Label

Non-Steroidal Anti-Inflammitory Drugs (NSAID's)

• FDA List of all Prescription and OTC NSAID's
• FDA NSAID medication guide
• FDA proposed revised package insert
• FDA supplemental letter adding risks of SJS to label

Ortho Evra

• Ortho Evra Litigation Information
• Ortho Evra Label
• Ortho Evra: FDA Updates Labeling for Ortho Evra Contraceptive Patch

Paxil

• Paxil Label
• Paxil Dear Doctor Letter
• Paxil (warning against cardiac malformations and other birth defects): Paroxetine HCl - Paxil and generic paroxetine
• Paxil (warning against PPHN): Information for Healthcare Professionals: Paroxetine (marketed as Paxil)

Reglan

• Reglan Label
• Reglan: FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs

Trasylol (Aprotinin)

• Trasylol (Aprotinin) Litigation Information
• Trasylol Label

Vioxx

• FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product
• David Graham memorandum on the safety of Vioxx
• Merck Found Liable in First Vioxx Trial

Yaz / Yasmin

• Yaz Label
• Yaz Warning Letter
• Yasmin Label
• Yasmin: Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - April 2010
• YAZ: Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets: Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation

Zoloft

• Zoloft Label

Zyprexa

• FDA Patient Information Sheet on Zyprexa
• Zyprexa