Diabetics uneasy over Metformin recall

THE voluntary recall of certain extended release Metformin — the most popular drug used in diabetes treatment — by the United States Food and Drug Administration (FDA) has left local diabetics on edge.

But health professionals are urging those who use the drug to remain calm.

“The recall of some brands of extended release Metformin is unfortunate and follows similar recent recalls of other medications, namely Valsartan and Ranitidine. It is understandably of significant concern since Metformin remains part of the first line medication treatment for type 2 diabetes which is common globally and in Jamaica. However, individuals taking Metformin should not panic,” cardiologist Dr Rohan Wilks told the Jamaica Observer.

The advisory issued by the FDA outlined that the agency was in contact with five companies to recommend they voluntarily recall extended release Metformin because the agency’s testing showed N-Nitrosodimethylamine (NDMA) above the acceptable intake limit in certain lots.The five brands include Apotex — all lots; Amneal — all lots; Marksans (labelled as Time-Cap) —one lot ; Lupin —one lot and Teva (labelled as Actavis) — 14 lots.

According to the FDA’s website, NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. Its impurities may increase the risk of cancer if people are exposed to them at above-acceptable levels over long periods of time.

Dr Wilks added: “Those taking the immediate release form should continue to take that form of Metformin. Those taking the extended release form should consult their physician. The good thing is that nowadays there are several medication options for the treatment of type 2 diabetes so if patients are not able to take Metformin they can explore other options with their physicians.”

In addition to the FDA recall, the Pharmaceutical Society of Jamaica (PSJ) reported low stock on some forms of the extended release Metformin drug. However, PSJ assured diabetics that there are other forms of the drug available. The PSJ also said it could not immediately determine whether the shortages were related to the recall or to bulk buying from patients as a result of COVID-19.

But, PSJ President Dr Ernestine Watson explained that the issue with the extended release not being readily available is that patients prefer that form of the Metformin drug as the side effects are less.

“The difference is whether it is immediate release or slow release. The slow or extended release are more acceptable since they have less of the gastrointestinal side effects,” Dr Watson said.

Likewise, Dr Wilks said while Metformin is generally tolerated by diabetics, the extended release Metformin is more favourable among patients.

“Metformin is also generally well tolerated by most patients although it is known to cause adverse gastrointestinal effects in a minority of patients. The extended release form had been a useful tool for doctors because of the lower risk of these adverse and/or side effects compared to the regular metformin or immediate release form,” he said.

But, Dr Wilks said the recall could have an effect on that preference.

“Many people who would have otherwise not have been able to experience the benefits of Metformin due to side effects from the immediate release form could benefit from taking the extended release form. The recall has now limited that option at least for the time being,” Dr Wilks said.

He encouraged those with the disease to make the necessary lifestyle changes required to lead a long and healthy life.

“People should be reminded that diabetes mellitus is a lifestyle-related condition and as a result significant adjustment in lifestyle, especially diet can minimise the need for medications to control the illness,” Dr Wilks said.

Further, internist Dr Kamika Fletcher Peddie also encouraged diabetics to not stop their medication, rather seek advice from their physicians.

“If you’re concerned that you may be taking one of the medication, it’s better you visit your doctor and find out from them what you should do. But the answer would not be to stop taking the tablet, especially since diabetes is a serious chronic illness and can lead to a lot of morbidity. They don’t want to sacrifice their health, especially since it may not even affect them. Visit your doctor if you’re concerned,” Dr Fletcher Peddie said. “It is important that diabetics regularly follow up with their doctors no matter what treatment they are on. This way they can be tested for diabetes control and monitored for organ damage.”

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