News Feature | January 22, 2014

FDA Pursues Manufacturers And Distributors Of Unapproved Drugs With Codeine

Source: Pharmaceutical Online

By Cyndi Root

The Food and Drug Administration (FDA) announced plans to pursue manufacturers and distributors of unapproved oral and injectable drugs containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrateen. Unapproved drug products escape the FDA's approval process, so there are safety risks to consumers. Some products omit warnings like side effects, dosage instructions, and drug interactions. Additionally, some products misrepresent appropriate ages and children are at risk of using adult products and doses.

Unapproved Codeine Products

Codeine is an opioid used as a pain or cough reliever. The FDA enforcement action targets unapproved drugs containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate. Since the FDA has not assessed the chemical composition, quality control, and labeling, these products are not considered safe. The chemical make-up of these compounds have intrinsic dangers like addiction, even if manufactured and marketed with FDA approval.  

  • Codeine Sulfate - codeine sulfate is a salt variation of codeine. Codeine sulfate may contain other sedating compounds resulting in drowsiness.  
  • Codeine Phosphate - codeine phosphate is a salt of codeine usually prescribed in 15, 30, and 60 mg tablets.
  • Dihydrocodeine Bitartrateen - dihydrocodeine bitartrate is a derivative of codeine. Dihydrocodeine bitartrate may include components resulting in increased sedation.

FDA Enforcement Actions

The FDA is proceeding with enforcement actions, even though it is not necessary according to any legal reason, the FD&C Act, or the Administrative Procedure Act. The agency is issuing notice to those entities marketing:  

  • single-ingredient codeine sulfate oral tablets
  • single-ingredient codeine sulfate oral solutions
  • single-ingredient codeine phosphate injection products
  • fixed-dose combination products containing codeine phosphate
  • fixed-dose combination products containing dihydrocodeine bitartrate

The agency will take action against manufacturers, marketers, and interstate shipping agencies. Those entities can expect this announcement to be the only warning, as the agency does not expect to issue any warning letters. Enforcement procedures may include but are not limited to seizure of products, injunctions, and other judicial proceedings. Interested parties can refer to agency guidance “Marketed Unapproved Drugs—Compliance Policy Guide” for more information.

Patients who are using these unapproved drugs should speak with a medical professional about replacing them with approved medications. Pharmacists that have these drugs in stock should remove them from shelves, contact the prescribing physician, and suggest approved alternatives.