Test results expected soon on recalled fertility drugs from Waltham pharmacy
Laboratory results are expected by the end of this week on fertility drugs recalled by a Waltham speciality pharmacy after an unknown substance was discovered floating in a vial of medication, a company spokesman said Tuesday.
Village Fertility Pharmacy announced Sunday that it had recalled several compounded medications shipped over the past three months, after the contamination discovery.
State health officials issued a cease and desist order on Feb. 20, prohibiting the company from making sterile compounded drugs, pending a state and federal investigation. Compounded drugs are specially prepared in formulations and doses unavailable off the shelf, and sterile medications are injected or used intravenously.
The recalled drugs had been shipped to 2,100 patients in 39 states, according to company spokesman David Ball, who said the pharmacy first became aware of a potential problem Feb. 16 when a patient brought a suspect vial to the pharmacy. Ball said the company immediately quarantined all medications from that same lot and notified state health officials.
Ball said the company promptly began notifying patients and health care providers about the recall, and arranging for replacement medications from alternate sources. The batch of suspect medications was made three months ago, and no adverse effects have been reported by patients who have used the drugs in that time, Ball said. The types of drugs recalled are injectable, which are the most dangerous if contaminated.
State health officials have been conducting surprise inspections of compounders after a fungal meningitis outbreak was linked to Framingham-based New England Compounding Center last fall. Contaminated injectable steroids made by the company have sickened 714 people, including 48 who died, in 20 states, according to the federal Centers for Disease Control and Prevention.
Massachusetts health officials have said New England Compounding was violating its state license by producing big batches of medications and shipping them out of state, operating more like a manufacturer, which is supposed to be regulated by federal officials. Compounders are allowed to mix individual prescriptions for specific patients.
State health department spokeswoman Anne Roach said in an e-mail Tuesday that Village Fertility Pharmacy’s out-of-state shipments are now “part of the ongoing investigation” of the company in the wake of the contamination discovery.
She said Village Pharmacy was last inspected in November by state investigators, who found “minor deficiencies that were addressed through a corrective plan.”
Ball, the company spokesman, said the medications it shipped out of state were sent for individual patients with prescriptions, as required by state law. The company’s primary business is in Massachusetts, and it remains open, selling other medications. Ball said sterile compounded drugs comprised just 5 percent of its business.
The two types of medications recalled by the company are commonly used in fertility treatments and made by other companies, but Village Pharmacy built a wide customer base because the company’s products and shipping schedule have been reliable, and are covered by health insurers, said Dr. Elizabeth Ginsburg, medical director of the in vitro fertilization program at Brigham and Women’s Hospital.
“When patients need to start a fertility medication, they need to start it on a particular day,” Ginsburg said. “There aren’t huge numbers of compounding pharmacies that are reliable and are accustomed to the fertility medications.”
The recall includes:
-- Progesterone Injection Cottonseed Oil 50 MG/ML
-- Progesterone Injection Olive Oil 50 MG/ML, 100 MG/ML
-- Progesterone Injection Sesame Oil 50 MG/ML, 100 MG/ML
-- Progesterone Injection Ethyl Oleate 50 MG/ML, 100 MG/ML
-- Hydroxy Progesterone Caproate 250 MG/ML
-- Compounded Leuprolide Acetate 1MG/.2ML
Patients with questions can call the Village Recall Hotline at 1-888-965-5813.Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.