Experts say that providers and patients should not experience significant disruptions in access to metformin despite five manufacturers recently recalling medications containing the drug. The experts urge patients not to discontinue or switch their medication before consulting with a doctor.
Five manufacturers have recently issued voluntary recalls of medications containing metformin, a diabetes drug. Those manufacturers are Apotex, Amneal, Marksans, Lupin and Teva. The recalls were due to contamination with N-nitrosodimethylamine (NDMA), which the U.S. Environmental Protection Agency considers a probable carcinogen.
The University of Arkansas’ Joseph Henske, MD said that patients shouldn’t be concerned about access to metformin as there are many metformin manufacturers in addition to the five who have issued recalls. “I have had several patients come to me with concerns, and they’ve contacted their pharmacy to find out who the manufacturer of their particular metformin product was. In all cases, they found out that their manufacturer was not on the list and they could continue taking their medication without anxiety.”
Caleb Alexander, MD of the Johns Hopkins Bloomberg School of Public Health noted that only one form of metformin has been recalled. “If patients and clinicians are concerned about the NDMA issue, switching to the immediate-release formulation is also an option, as there have been no recalls associated with that formulation.”
Pharmacies are not reporting difficulty in obtaining either the immediate or extended release versions of metformin.
“We have an adequate supply of non-recalled product to take care of our patients’ needs and will dispense alternate metformin products that have not been recalled,” said CVS Health’s Mike DeAngelis. “We are also reaching out to our patients affected by this recall through a combination of text messages, letters and phone calls. Patients who were dispensed medication that has been recalled should not stop their metformin therapy or alter their medication before speaking with their health care provider. In the event of any medication recall, our pharmacy teams will work with affected patients and their health care providers to support continuity of care.”
Henske said that the NDMA contamination in metformin is likely the result of the manufacturing process. “We do not want patients or providers to think that metformin is unsafe at baseline,” he said. “It is one of the safest and most commonly prescribed drugs on the market, but something in the manufacturing process for the XR formulation has produced this contamination in some lots.”