Ministry of Health allays fears over safety of diabetes drug

Dubai: The Ministry of Health has allayed fears of some diabetic patients who feared that a pill they are taking could be a fake as it does not seem to dissolve.

Fatima, a diabetic patient, said she took the drug Glucophage XR (500mg) and saw that the whole tablet passed out of her body through the passing of stool.

She said other women who took the tablet failed to notice this till she pointed it out to them.

Fatima said her worry was what would happen if the tablet remains inside the body and how it would affect the internal organs.

She said she contacted the drug company and was told it will investigate the matter.

The 32 year-old said she took the tablets for a week and discontinued it after she went back to her doctor for an explanation and was told it could be a problem with her digestion. “Doctors should tell patients what to expect when they take this pill,” she said. 

Fatima was sure that particular batch of drug was counterfeit after she went in for a test and found no problem with her abdomen.

Merck Serono, one of the leading pharmaceutical companies in the field of diabetes, said in a statement that Glucophage XR is an advanced formulation of the oral anti-diabetic agent Metformin.

“When the tablet is swallowed, it absorbs water, swells and remains for a longer period of time in the stomach, releasing Metformin slowly into the upper part of the intestine. This is sufficient to allow for once daily dosing rather than 2 to 3 times daily intakes required for the immediate release formulations of Metformin, making it more convenient for the patients,” said the statement. 

It further points out that “with this advanced tablet technology, it is normal that remains of the tablet can show up in the patients’ stool the morning after the ingestion of the tablet and therefore patients and medical practitioners should be reassured.”

“The active agent of the tablet, Metformin, is absorbed to the same extent as the regular Metformin but at a slower pace, allowing for lesser gastric discomfort and once daily dosing without reducing the effectiveness of the drug and without major safety concerns.”

In clinical trials with more than 1,200 patients, Glucophage XR was shown to be comparable to Glucophage in lowering patients' blood sugar levels. In addition to initial therapy, the Food and Drug Administration (FDA) of the US also approved Glucophage XR for use by patients who require combination therapy with Sulfonylureas or insulin, it said.

Glucophage XR has been approved by UAE Ministry of Health and is available for diabetic Type 2 patients, it noted.

Pharmacist Nawaz Valiyakth at Ibn Batuta Mall said the tablet formulation is encased in a packing to ensure its slow release. That packing will expand and not dissolve quickly, he said. 

Glucophage assists in stabilizing blood sugar and regularise the menstrual cycle, according to Dr Devanapalli Shashikala. It helps patients with polycystic ovaries, she said.

When told about the fears of the patients regarding the drug that it could be counterfeit, Dr Amin Al Amiri, CEO for medical practice and license, told Gulf News that there was no way a fake drug can get into the country. He said the import process includes verification of the contents of the drug at the Ministry’s laboratories.

“There are stringent checks at the entry points as airports and seaports,” he said and each consignment is checked by customs inspectors. 

All medicines imported are either approved by the Food and Drug Administration (FDA) of the US or the European Medicines Agency, he said. 

Pharmacies in the country are inspected randomly and those caught selling counterfeit drugs are closed for some period and fined heavily, said Al Amiri.

But he admitted that some individuals could be bringing in drugs for their personal use, which is very difficult to check. “As you know thousands of people come into the country every day,” he said.