Valisure Expands Capabilities To Test Medications For Cancer Causing Contaminants Implicated In Recent Recalls
NEW HAVEN, Conn., March 15, 2019 /PRNewswire/ -- In response to the multitude of recalls for angiotensin II receptor blockers (ARB), a sartan class drug that is commonly used to treat high blood pressure, Valisure, the first online Analytical Pharmacy, announced it has expanded its testing capabilities to screen samples from all batches of medications it dispenses for the cancer causing contaminants N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N,N-Dimethylformamide (DMF), the chemical solvent that has been implicated in the production of these impurities.
Since the beginning of July 2018, the Food and Drug Administration (FDA) has continued to publish recalls in the sartan class of drugs from numerous manufacturers. These common prescription drugs include valsartan, losartan, and irbesartan.
"Considering the world-wide concern over these contaminants, Valisure has worked hard to expand our workflow to incorporate one of the FDA's suggested GC/MS testing methods. We employ this test to help ensure that the medications we dispense do not contain these impurities, for which the FDA has suggested acceptable intake limits," stated David Light, CEO and Founder of Valisure. "We at Valisure have made the decision to expand our testing standards to go above and beyond the acceptable FDA limits for NDMA and NDEA. Furthermore, we will closely examine levels of DMF, the industrial solvent implicated in creating these contaminants and itself classified as probably carcinogenic to humans."
Valisure has established the following guidelines for its testing process:
- N-Nitrosodimethylamine (NDMA), classified as probably carcinogenic to humans. The FDA has suggested that it is acceptable to intake 96 nanograms (ng) of NDMA per day. Valisure has calibrated a detection limit of 25 ng.
- N-Nitrosodiethylamine (NDEA), classified as probably carcinogenic to humans. The FDA has suggested that it is acceptable to intake 26.5 nanograms (ng) of NDEA per day. Valisure has calibrated a detection limit of 25 ng.
Valisure's Harvard- and Yale-trained scientists developed efficient technologies and systems to analyze the chemical properties and ingredients of samples from every batch of prescription medication, over-the-counter drug and supplement it dispenses without adding costs to consumers. Using their laboratory located at Yale Science Park in New Haven, CT, Valisure delivers medications that come with an easy-to-read certificate of analysis specifying important chemical properties, now with the addition of identifying the presence of the aforementioned contaminants.
"During our testing process, we have identified batches of medications from certain manufacturers that do contain traces of such contaminants and we have also found manufacturers whose same drugs do not have detectable levels of these impurities. At Valisure, we strive to dispense medications from batches where no contaminants have been detected, even at trace levels," stated Kaury Kucera, PhD, Chief Scientific Officer of Valisure. "No other pharmacy in the U.S. does their own chemical analysis on every batch of medication it sells other than Valisure, and it is our mission to try to bring an additional level of safety and peace of mind to our patients and their families."
Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to helping ensure the safety, quality and consistency of the medications it delivers to consumers. In response to rising concerns about counterfeit medications, generics and overseas manufacturing, Valisure has developed proprietary analytical technology that is used to screen out poor-quality batches. Every prescription Valisure ships comes with a certificate of analysis listing important chemical properties of the samples analyzed at Valisure's lab. Founded by a team of Harvard- and Yale-trained scientists, Valisure strives to bring consumers the utmost quality, consistency and transparency in medications. Valisure has ISO 17025 accreditation and is DEA and FDA registered. For more information, please visit www.valisure.com or follow @Valisure on Twitter.
Upcoming Life Sciences Events
- May 2019
- Zurich: The Pharmaceutical Out-licensing Course
- New York: Inhalation & Respiratory Drug Delivery 2019
- June 2019
- Philadelphia, PA: Product and Company Valuation Course