FDA: Five Brands of Diabetes Meds Recalled
WASHINGTON (AP). U.S. health regulators told five drugmakers to recall a widely used diabetes medication, because of possible cancer-causing contaminants.
Metformin and Diabetes
Patients with Type 2 diabetes often use metformin alone or with other drugs. Because, it helps control blood sugar levels. More than 34 million people in the U.S. have this disease.
Cancer Causing Possibilities
The FDA said late Thursday that several batches of the drug metformin tested positive for unsafe levels of N-Nitrosodimethylamine (NDMA(. Which is a possible cancer-causing chemical that can form as a manufacturing byproduct. They found the chemical in dozens of shipments of blood pressure and heartburn drugs last year. Which triggered recalls of Zantac and other popular over-the-counter and prescription medications.
What Should Diabetics Do?
Patients should continue taking metformin drugs until their doctor can prescribe a replacement, according to the FDA. Because, discontinuing this medication could be risky.
Will this Mean Drug Shortages?
Regulators are still assessing whether the recalls will lead to shortages of metformin. However, a number of other companies make generic versions of the drugs. And they don’t appear to be affected.
Which Metformin Drugs are Recalled?
After the FDA found contamination in one lot, drugmaker Apotex Corp. recalled its extended-release metformin earlier this week. Apotex said it voluntarily recalled the drug out of an abundance of caution. The company said it stopped selling the drug in the U.S. in February 2019. And, that little remains on the market. The FDA announcement did not name the four other drugmakers in the recall.
The agency noted that no contamination problems have been found in immediate-release metformin. In other words, this only includes extended-release metformin.
About the FDA
The Food and Drug Administration (FDA) is responsible for ensuring the safety of medicines in the U.S. And, that conditions are safe, sanitary and meet federal quality standards. But, government inspectors have repeatedly criticized the agency. Because, they say they’re falling short in reviewing overseas manufacturing plants in Asia.
In March, the FDA suspended nearly all inspections due to the coronavirus outbreak.