|Domperidone--Courtesy of Bristol Laboratories|
The FDA has been cracking down on questionable practices at the largest compounding pharmacies, and it has caught one doing a big no-no. It has been manufacturing an unapproved drug.
According to a warning letter sent Feb. 28 and posted this week on the FDA website, Total Pharmacy Services has been making domperidone, a drug some breastfeeding women take to boost lactation. The letter to Houma, LA-based Total Pharmacy Services says compounding pharmacies can be exempt from FDA rules if they have valid prescriptions for the drugs they make, which it didn't, but even if it had, domperidone is an unapproved drug and so wouldn't qualify.
A decade ago, the FDA sent warning letters to some compounding pharmacies, saying they should not be making the drug. The agency cautioned women against using domperidone because of its heart risks, pointing out that there have been reports of women having heart attacks, and some even dying, after getting injections of the hormone-boosting drug. Women were then buying it from compounding pharmacies or bringing it in from foreign countries. Today it can be purchased online from foreign-based pharmacies.
Domperidone is approved in some countries outside of the U.S. for treating nausea. Janssen's Motilium is such a version. Just this month, the European Medicines Agency (EMA) recommended narrowing the use of the drug to treating some nausea and vomiting, and no longer for bloating and heartburn. It also recommended that doses be reduced, all because of the heart risks.
Making an unapproved drug was not the only violation at Total Pharmacy Services noted by the FDA. The inspectors also indicated there was no proof that the company's hoods in the production area do a good enough job to prevent contamination and noted workers "wearing non-sterile gowning and performing aseptic operations with their arms resting on the work surface of the ISO 5 area," two things that also brought its sterile conditions into question.
Last year, Congress gave the FDA broader authority over compounding pharmacies after a fatal outbreak of fungal meningitis in 2012 tied to a contaminated drug made by a compounding pharmacy infected hundreds and killed dozens of people.