The Food and Drug Administration (FDA) is amending its regulations to revise the list of drugs that have been withdrawn or removed from the market because the drugs or components of these drugs have been found to be unsafe or ineffective. These drugs may also not be compounded unless an exception exits to allow for compounding under certain circumstances. The revisions are necessary as new information has been brought to the FDA’s attention since the original list was published back in 1999.
The final rule adds 24 entries to the list of drug products, modifies one of the entries (bromfenac sodium), and revises the list’s title and introductory text. At this time, the FDA is not finalizing the entry in the proposed rule for all extended-release drugs containing oxycodone HCl that have not been determined by the FDA to have abuse-deterrent properties; the addition of oxycodone HCl to the list remains under consideration.
The 24 drugs being added to the list of withdrawn or removed products include:
• Adenosine Phosphate
• Alatrofloxacin mesylate
• Bromfenac sodium (all drugs except ophthalmic solutions)
• Cerivastatin sodium
• Esmolol HCl (all parenteral drug products that supply 250mg/mL of concentrated esmolol per 10mL ampule)
• Gatifloxacin (except ophthalmic solutions)
• Novobiocin sodium
• Pergolide mesylate
• Phenylpropanolamine (PPA)
• Polyethylene glycol (PEG) 3350, sodium chloride, sodium bicarbonate, potassium chloride, and bisacodyl
• Rapacuronium bromide
• Sibutramine HCl
• Tegaserod maleate
• Trovafloxacin mesylate
The FDA received a comment requesting that oral chloramphenicol not be included on this list because it was being used to control hemorrhagic fever-like illnesses (eg, Lassa Fever, Ebola) and that control and survival benefits outweigh the risks of thrombocytopenia and aplastic anemia in the already anemic patient when used in the short term appropriately. The FDA disagreed with this revision stating that the Agency was unaware of any evidence that the drug has antiviral activity against causative agents of viral hemorrhagic fever. In February 2015, the Advisory Committee voted to include all oral drug products containing chloramphenicol to the list.
The entire list of withdrawn or removed from the market drug products can be found here.