FDA Investigation into Compounded Products

The FDA website posted the summary of their investigation into two serious adverse events associated with ImprimisRX’s compounded curcumin emulsion product for injection.

The full summary is available on the FDA website, click here.

The short version:

Two patients were administered infusions of curcumin (a component of the spice tumeric) compounded with polyethene glycol (PEG) 40 castor oil.

One patient a female 30-year old experienced cardiac arrest, the patient suffered depleted oxygen brain injury and subsequently died.  The second patient a 71-year old male developed a hypersensitivity reaction, he was transferred to a nearby emergency room where he was treated and released.

FDA’s investigation into the adverse events associated with ImprimisRx’s curcumin emulsion product for injection highlights some of the risks associated with compounded drugs, particularly those that use non-pharmaceutical grade components and ingredients lacking a USP monograph. The risks illustrated in this case include:

  • the absence of a label warning about hypersensitivity reactions associated with the PEG 40 castor oil;
  • the use of an ungraded inactive ingredient, i.e., PEG 40 castor oil, that is not suitable for human consumption or therapeutic use and may contain impurities such as DEG; and
  • the IV administration of curcumin, despite the fact that its safety profile by this route of administration has not been established, nor has its effectiveness in treating eczema or thrombocytopenia.

Pharmacy error statistics as posted by the Hannon Legal Group:

  • Medication errors account for approximately 7000 deaths annually in hospitals alone and tens of thousands more in outpatient facilities.
  • It is estimated that between 2.2 million and 3.7 million medication dispensing errors have occurred in the U.S. in each of the past eight years which caused serious health problems or death.
  • According to the FDA, over 1.3 million people are injured each year due to medication mistakes.
  • Preventable adverse drug events (ADEs) cost the healthcare system $2 billion every year.