Who is ImprimisRx?
Imprimis Pharmaceuticals is a compounding pharmaceutical company that “delivers high-quality and innovative” medicines to physicians and patients at fractions of the cost of the original drug. They offer compounded formulas for areas in ophthalmology, urology, and dermatology.
What is Compounding?
In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounded medications aren’t commercially available. This means that the drug is not currently being made by a pharmaceutical company and therefore doesn’t have a trade or brand name like the typical prescription you would fill at your local pharmacy.
Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or effectiveness of compounded drugs. Compounded drugs also lack an FDA finding of manufacturing quality before such drugs are marketed. There can be health risks associated with compounded drugs that do not meet federal quality standards. Compounded drugs made using poor quality practices may be sub- or super‑potent, contaminated, or otherwise adulterated.
Typically, Drug manufacturers bear the costs of extensive clinical testing before their products go to market, as well as the cost of maintaining quality standards (called 'Good Manufacturing Practices') in the factories where they produce drugs. Compounding firms are not subject to trial costs, and traditional compounders are not subject to GMP. Read more about the risks here.
Recent deaths associated with ImprimisRx's compounded drugs has drawn the FDA’s attention to Investigate.
Two patients were injected with a lethal dose of ungraded industrial castor oil mixed with curcumin, a component of turmeric and immediately experience negative effects.
On March 10, 2017, the U.S. Food and drug Administration received an adverse reaction reports in regard to a 30-year-old female patient who experienced cardiac arrest after IV administration of a curcumin emulsion product compounded by ImprimisRx. As reported, within minutes of receiving the IV the patient became pulseless and required CPR. The patient experienced anoxic brain injury and died.
Again, on May 1, 2017, the FDA received an adverse event report in regard to a 71-year-old male patient who immediately experienced coughing and a rash upon the IV administration of ImprimisRx’s compounded curcumin emulsion product. His symptoms quickly escalated to shortness of breath, itching, and hypotension. He was sent to a nearby Emergency room and treated there.
According to reports, when the FDA collected and analyzed samples of the IV Bag administered to both the female and male patients and the ImprimisRx emulsion vials used to prepare the bag they found alarming discoveries. The FDA found that the PEG 40 Castor oil used by ImprimisRx was ungraded, not suitable for human consumption or therapeutic use. What is was suitable for was general industrial purposes such as break fluid or antifreeze. They also found a manufacturing impurity of PEG called diethylene glycol, or DEG. DEG is known to be a central system depressant, as well as a potent toxin for the kidney and liver, that is fatal upon ingestion.
On June 23, 2017, ImprimisRx recalled all unexpired products containing the ungraded PEG 40 castor oil.
The FDA encourages health care professionals to report adverse events associated with the use of compounded drug products, here.
If you or a loved one were harmed by compounded drugs, please contact us immediately at Info@myPirl.com!
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