Mistakes happen. We hear stories every week about prescription drugs that are sub-potent or superpotent. Very often the drugs in our medicine cabinets are subpotent meaning they have insufficient Active Pharmaceutical Ingredient (API). Frequently these poor quality drugs are manufactured in India or China where regulatory oversight is spotty. But not always.
April 16 FDA Alert Pharmakon Injectable Morphine Sulfate
Drugs that are slightly over or under potent are rarely deadly. Injectable morphine sulfate manufactured by Pharmakon Pharmaceuticals may be the exception. According to an FDA alert issued on April 16th, injectable morphine sulfate manufactured by Pharmakon may be nearly 2500% its labeled potency. It also may not be sterile. In the words of the FDA, administration of their morphine product may result in death.
Pharmakon is a compounding facility that produced the morphine sulfate at its Noblesville, Indiana facility. A recent FDA inspection found “insanitary conditions including poor sterile production practices.” Testing confirmed multiple instances of environmental contamination including in clean room production areas.
Of greater concern is the potency problem. A powerful narcotic drug that is 2500% superpotent could easily result in death. We were shocked to learn of these deviations.
Pharmakon Refuses to Recall
Worse, a day after the FDA urged the company to cease production, Pharmakon Pharmaceuticals apparently said it would neither recall its products nor stop making more. That caused the FDA to issue the alert just days later on April 16th. Hopefully the FDA and Justice Department will launch a criminal probe in light of the company’s reported refusal to protect human life.
2014, 2015 Pharmakon cGMP and Potency Problems
Our story begins in 2014. Pharmakon was inspected in March and April of 2014. Following those inspections, the FDA issued a warning letter to the company after finding potency, production and sanitation concerns. Regulators also found numerous cGMP (current Good Manufacturing Practices) violations. The multiple inspections followed reports of over-sedation of neo-natal infants who were received improperly labeled midazolam.
Thankfully, the infants survived and there were no reported deaths attributable to the morphine administrations. The near tragedies, presence of sub- and super-potent drugs and unsanitary practices should have been a wake up call for the company. Apparently, it wasn’t. In April of 2015, the FDA issued a warning letter.
Pharmakon’s Problems Continue
In February of this year, Pharmakon voluntarily recalled its morphine sulfate after lab tests showed more super-potency problems. Two problems in two years prompted the FDA to increase scrutiny of the facility. According to the FDA’s unusual April 16th weekend announcement, a recent inspection revealed product that is 2500% super-potent.
Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death.
We remain deeply disturbed that the company is refusing to recall its morphine products and continues to manufacture. In our opinion, the company’s actions can no longer be considered negligent.
We hope that pharmaceutical companies worldwide always self-report and recall defective products at the first sign of problems. From what we can glean from public records, Pharmakon’s problems were uncovered once by lab tests, once by infants who were over-sedated and twice by FDA regulators. That is far too many problems in a two-year period.
Whistleblower Awards under the False Claims Act
Under the federal False Claims Act, pharmaceutical workers worldwide can seek an award from the U.S. Department of Justice if they possess inside information about pharmaceutical drugs being sold or dispensed to Medicare, Tricare or Medicaid recipients. There is no citizenship or residency requirement to receive an award.
Reporting violations and coming forward is about more than an award, of course. Adulterated drugs can kill. Even minor cGMP violations or potency issues can lead to infections or prolonged suffering by patients.
The Pharmaceutical Integrity Coalition’s mission is to restore integrity to our noble profession. We also help concerned workers break their silence and report violations. We can help you report violations, stop corporate greed and fraud, find a lawyer if you suffer retaliation and find a lawyer if you are interested in seeking an award. Our services are completely confidential and we never seek payment for what we do.
If you have information about cGMP violations, illegal off-label marketing or adulterated product entering the marketplace, call us or email us today. By coming forward, you may save a life.
Excerpt from April 16th FDA CDER Statement and Alert regarding Pharmakon Pharmaceuticals, Inc.:
ISSUE: FDA is alerting health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues.
BACKGROUND: FDA recently inspected Pharmakon’s facility following the company’s voluntary recall of super-potent morphine sulfate 0.5 mg/ml preservative free in 0.9% sodium chloride, 1 ml syringe, CII, for intravenous use. FDA test results showed the product to be nearly 2,500 percent the labeled potency. During the inspection, investigators observed insanitary conditions, including poor sterile production practices, and other deficiencies, which raise concerns about Pharmakon’s ability to assure the sterility and quality of drug products that it produces. Additionally, FDA testing confirmed environmental contamination on multiple sites within the clean rooms, including the critical ISO-5 area.
On April 11, 2016, FDA recommended that Pharmakon cease sterile operations until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile. On April 12, 2016, Pharmakon informed FDA that it would neither initiate a recall nor cease sterile production. Therefore, FDA is alerting health care professionals not to use drug products marketed as sterile from Pharmakon.
RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any drug products marketed as sterile from Pharmakon, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.