FDA Finds Contamination, Urine in Cancer Drug Factory

Representing Atlanta, Savannah, Columbus, Decatur, Augusta & nearby areas of Georgia

 

When we take medications, we trust that they have been safely manufactured. Unfortunately, this is not always the case. Sometimes the negligence of a pharmaceutical manufacturer can cause otherwise safe medications to become dangerous prescriptions.

Recently, concerns of this nature were raised about the cancer drug Doxil.

A federal Food and Drug Administration inspection of the plant where Doxil is manufactured revealed a troubling disregard for patient safety. Some of the violations that the FDA discovered included:

  • A 10-gallon can filled with urine was found in a storage room
  • Air sampling revealed microbial contamination and the manufacturer could not identify the source
  • The company could not show that its product meets acceptable levels of sterility
  • The company was behind on at least 107 required preventative maintenance activities
  • Quality-control staff lacked proper training, expertise and oversight

Doxil is supposed to be a sterile drug. It is prescribed to patients who suffer from ovarian cancer, bone cancer and an HIV-related cancer known as Kaposi's sarcoma. Many of these patients have compromised immune systems as a result of their illness and its accompanying treatment. An unanticipated bacterial or viral infection could cause serious harm.

To make matters worse, Doxil was in short supply, even before the investigation. Approximately 2,000 patients currently receive the drug, but another 2,240 are on a waiting list.

The wait will now be even longer. Ben Venue - Doxil's manufacturer - has suspended production while it works to remedy the deficiencies.

When manufacturers cut corners on safety, innocent people suffer. We owe our vulnerable citizens better than to provide them with dangerous or defective drugs.

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