FDA: MORE Diabetes Meds Recalled
You may recall back in March, the FDA recalled five brands of a widely used diabetes medication, because of possible cancer-causing contaminants. This week, the FDA has issued a new warning to another company to pull more diabetic drugs from store shelves.
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.
Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled NDC’s returned to Inmar Rx Solutions, Inc.; the NDC number can be found on the top of the bottle label.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. You may complete and submit the report Online.
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?
Of course, in March, the FDA found contamination in Metformin made by Apotex Corp. who then recalled its extended-release metformin.
Now, Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP to the consumer level. In other words, they’ve continued to assess with the FDA. And, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA).
Therefore, out of an abundance of caution, the company is recalling all batches in the U.S. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.
Metformin Hydrochloride Extended-Release Tablets USP
11/21/2018 – 05/27/2020
|500mg||68180-336-07||11/05/2018 – 05/22/2020|
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.
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