Important information about your Metanx prescription

Eric M. Wingerter is the President and CEO of Pamlab Pharmaceuticals. Mr. Wingerter wrote two letters to his customers to update and inform them about products that are being substituted for Metanx and other Pamlab products. One of the main products of my concern is Neurpath-B. This is the product that could potentially be substituted for Metanx by your pharmacy. I am going to summarize these two letters for you. If you would like to read the actual letters and browse the Metanx website please visit http://www.metanx.com and click on "Attention Metanx Patients: Important information about your Metanx prescription" located at the top of the page.

Acella Pharmaceuticals products, including Neurpath-B, contain an active ingredient called XOLAFIN-B (described as L-methylfolate calcium). This ingredient comes from a manufacturer in China that is not cGMP (current good manufacturing practice) certified in China or the United States. Pamlabs Metanx also contains a formula of L-methylfolate calcium called Metafolin. All active ingredients in Pamlabs Metafolin (Pamlabs L-methylfolate calcium formula) containing products, including Metanx, are US cGMP compliant.

All ingredients in medical foods must be GRAS (Generally Regarded As Safe) or FDA (Food and Drug Administration) approved. Since XOLAFIN-B is manufactured in a Chinese facility that is not cGMP certified by either China or the United States it cannot be considered GRAS. Pamlabs active ingredients that compete with Acella products have verified GRAS status which took several years to achieve.

Acella labels its Neurpath-B product with a 24 month expiratioin date. Acella nor its contract manufacturer has actually performed any stability testing to support this claim. Stability testing, in the pharmaceutical field, tests how well a product retains its quality over the life span of the product. On June 23, 2010 a third party testing laboratory, BioScreen Testing Services, evaluated Neurpath-B with an expiration date of April 2012. The assay results showed that the active ingredient XOLAFIN-B to be out of specification within 2 months of being manufactured.

The Doctors at Gulfcoast Foot and Ankle want you to know the facts about this alleged substitute for Metanx. Please feel free to contact us at Gulfcoast Foot and Ankle with questions or concerns you may have. We will try our best to get you the answers you need in a timely fashion.