FDA Committee Actions
Drug Shortages in Clinical Gastroenterology
ACG is currently working closely with the FDA to help resolve the drug shortages many GI clinicians and practices are experiencing today.
“Feasibility of Mucosal Healing as a Clinically Significant Endpoint in Inflammatory Bowel Disease Clinical Trials”
American College of Gastroenterology and the U.S. Food & Drug Administration Joint Workshop
The FDA’s Generic-Drug Approval Process: Similarities to and Differences From Brand-Name Drugs
How the FDA Manages Drug Safety With Black Box Warnings, Use Restrictions, and Drug Removal, With Attention to Gastrointestinal Medications
Radiation and CT Scans:
Multi-Society Position Statement: Nonanesthesiologist Administration of Propofol for GI Endoscopy
A glimpse at the future Food and Drug Administration: A summary of the FDA Amendments Act of 2007
Charles E. Brady M.D., Arthur A. Ciociola, Ph.D. and FDA Related Matters Committee
Tysabri (natalizumab) Injection for IV Use FDA Public Health Advisory
Early FDA Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
Cimzia Notification of Product Approval to Companies
Tysabri Notification of Product Approval to Companies
Recalls, Market Withdrawals & Safety Alerts Important to GI
FDA Drug Safety Communication: Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs)
FDA MedWatch – Victrelis (boceprevir) and Ritonavir-Boosted Human Immunodeficiency Virus (HIV) Protease Inhibitor Drugs
Drug Safety Communication – Hepatitis C virus (HCV) protease inhibitor Victrelis (boceprevir) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these medicines when they are used together
FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria
FDA withdraws Halflytely and Bisacodyl Tablets Bowel Prep Kit from market for safety and effectiveness reasons
The Food and Drug Administration (FDA) has determined that Halflytely and Bisacodyl Tablets Bowel Prep Kit (polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 milligrams (mg) (10-mg bisacodyl)) was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for bowel prep kits
containing PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride for oral solution and two bisacodyl delayed release tablets, 5 mg.
FDA reports of a rare cancer of white blood cells primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with tumor necrosis factor (TNF) blockers
Prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time
FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia.
Federal government issues joint-safety announcement re: Preventing Cross-Contamination in Endoscope Processing
FDA Drug Safety Communication: PPIs and Possible Fracture Risk
Recall: Baxter Colleague Pump
Plavix – Boxed Warning
FDA Recommendation on Plavix and PPIs
Other FDA Links
FDA
FDA Approved Drug Products
Guidances (Drugs)
FDA MedWatch: Report an Adverse Event to FDA (form FDA 3500)
Recalls, Market Withdrawals & Safety Alerts
Index to Specific Drug Information
Food Safety
Other Important Links
The CDC has released a Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care. The transition of healthcare from acute care hospitals to outpatient (ambulatory care settings), along with ongoing outbreaks associated with breakdowns in basic infection prevention, such as the reuse of syringes, has prompted the need for this guidance.
HHS Regulations
CMS Medicare Physician Guide
State Legislatures Internet Links
Clinical Trials.gov
