FDA Warns Overland Park Pharmacy Over Lactation Drug
An Overland Park business has been ensnared in a crackdown on compounding pharmacies that make products containing a drug used to boost lactation in breastfeeding women.
The Food and Drug Administration last month issued a warning letter to Perry Drug Inc. citing it for compounding drug products containing domperidone, a drug not approved by the FDA.
Although domperidone is approved in several countries to treat gastric disorders, it is not approved anywhere to enhance breast milk production.
Perry Drug’s president, Dena K. Perry, referred inquiries to the company’s Washington, D.C., attorney, Karla L. Palmer, who said the company had stopped dispensing domperidone and would no longer do so without notice to the FDA.
“Hundreds of compounding pharmacies have received these types of letters from FDA since 2012,” Palmer said. “Dena Perry’s pharmacy is no different from those. Other than the fact that she has not been compounding sterile drug products for quite some time, FDA never tested the products and nobody to the best of our knowledge reported an adverse event as the result of any Perry Drug products.”
Marc Willis, an FDA spokesman, said the agency's investigation of Perry Drug was still considered an open case.
"A follow-up inspection is the usual means for FDA to verify the corrective actions made by a firm as a result of a Warning Letter," Willis said in an email. "FDA normally completes a follow-up inspection of the company within six months of the date on the warning letter."
Once the FDA confirms that the company has corrected the violations, he said, it will issue a close-out letter.
Records on file with the Kansas Secretary of State show Perry Drug was incorporated in 2008. The compounding pharmacy is housed in an office building next to Overland Park Regional Medical Center.
Compounding pharmacies combine drugs or drug ingredients to create medications tailored to the needs of individual patients.
Since 2004, the FDA has been warning compounding pharmacies not to make domperidone, citing concerns about serious health risks associated with the drug, including arrhythmias, cardiac arrest and sudden death.
In its warning letter to Perry Drug, the FDA also said its investigator observed “serious deficiencies” in its practices for producing sterile drug products, “which put patients at risk.”
Palmer said Perry had taken the FDA’s concerns seriously and “responded in all respects appropriately to the letter.”
“She looks forward to continuing to compound drug products that are non-sterile to meet her patients’ needs,” Palmer said.
Editor's note: This story was updated on March 12 to include the comments of an FDA spokesman.
Dan Margolies, editor of the Heartland Health Monitor team, is based at KCUR.