FDA Warns of Prescription Errors with Similar Brand Names

The FDA warns of prescription errors due to similar brand names: Brilinta (ticagrelor) and Brintellix (vortioxetine). PGXL reports are designed to provide both brand and generic drug names to reduce these types of errors, including for these two medications.

The U.S. Food and Drug Administration is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. We have determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue. As a result, we are alerting the public about this safety issue.

Read the Full Article Here

by Mick Miller

Drug Combinations You Should Avoid

From MSN | Health & Fitness:

You can buy over-the-counter drugs without a prescription, but they still have risks—especially if you treat yourself with more than one at a time.

Even people who read labels closely don’t always spot potential problems, such as two OTC meds with the same active ingredient, according to a recent study in the Journal of Public Policy & Marketing. Keep yourself safe while getting healthy. Use the following tips to avoid these potentially perilous pairs.

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by Mick Miller

FDA approves new atypical antipsychotic Rexulti® (brexpiprazole) with pharmacogenetic dosing

Kristen Reynolds, PhD
PGXL Laboratories

On July 13, 2015 the FDA approved a new medication for the treatment of schizophrenia and for augmentation of antidepressant therapy in major depressive disorder in adults. Rexulti® (brexpiprazole, Otsuka Pharmaceutical) is an atypical antipsychotic hailed as Otsuka’s successor of Abilify® (aripiprazole), the top selling drug of 2013 whose patent expired in October of 2014.

Brexpiprazole, similar to aripiprazole, is dependent on hepatic CYP2D6 and CYP3A4 for clearance. Approximately 7-10% of the general population possesses an inherited form of the CYP2D6 gene that results in decreased clearance. Individuals with these genetic differences are called Poor Metabolizers (PMs) and are at risk of adverse drug reactions due to higher-than-normal drug exposure at standard doses.

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by Mick Miller

FDA Alert: The FDA continues to assert that NSAIDs can increase the risk of heart attacks and strokes.

Kristen Reynolds, PhD and Cody Greenlaw, PharmD
PGXL Laboratories

What’s the issue?

On July 9, 2015, the U.S. Food and Drug Administration (FDA) issued a safety advisory regarding increased risk of cardiovascular events in patients taking non-steroidal anti-inflammatory drugs (NSAIDs). The advisory indicates that non-aspirin NSAIDs, commonly taken for pain and fever, can increase the risk of heart attack and stroke even in patients without other known heart disease risk factors. The increased risk can occur within the first weeks of NSAID use, and may increase with longer duration of therapy and higher dosages.

What are the risks and medications involved?

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by Mick Miller

PGXL Partners with NorthShore

northshoreNew PGx Clinic a ‘Model’ for Burgeoning Field PGXL has been contracted by NorthShore University HealthSystem in Evanston, IL for its 15-gene panel assay that covers drug metabolism enzymes and transporters related to treatment for cardiovascular problems as well as psychiatric disorders, pain management and cancer. In March, NorthShore took its personalized medicine efforts a step further, launching the first PGx clinic in the Chicago area. The launch came in response to requests from both patients and clinicians, and is housed within NorthShore’s Center for Medical Genetics.

NorthShore’s Pharmacogenomics Clinic currently uses a third-party assay—a 15-gene panel (PGXL Laboratories; Table) that covers drug metabolism enzymes and transporters related to treatment for cardiovascular problems as well as cancer, pain management and psychiatric disorders. Such testing is far more comprehensive than what Dr. Mangold underwent years ago.

by Mick Miller

Training Pharmacists in Genetics

Sillivan College of Pharmacy 300PGXL Laboratories will provide genetics training for 3rd year PharmD students from the Sullivan University College of Pharmacy. The five-week clinical rotation will provide students with real-practice experience in the use of genetics to guide drug choice and dosing.

“One of PGXL’s missions is to train the next generation of medical professionals,” says Dr. Roland Valdes Jr., President of PGXL. “For these students, pharmacogenetics will be an important dimension of their practice in enabling personalize medicine. We are thrilled, as part of our community engagement, to be able to jump-start their understanding of this important new discipline.”

For more detailed information about the program, CLICK HERE.

by Tom Johnson

Faster Isolation and Analysis of Circulating Tumor Cells

Tech Unwraps 500PGXL has upgraded its ability to isolate individual, intact cells, including circulating tumor cells.

The lab installed a faster and more analytically powerful Version 2 DEPArrayTM. The system’s image-based cell identification and electromagnetic capture and manipulation of cells enables the isolation of specific rare cells, leaving behind the contaminants, cell fragments and false positives that can confound downstream analysis. In addition, the DEPArray’s movement of cells is so gentle that living cells can be recovered directly to culture plates.

PGXL Technologies is the only company offering DEPArray service on a contract basis.

Further information and technical specs on the DEPArray are available here.

by Tom Johnson

PGXL Adds NextGen Sequencing

PGXL Technologies, which identifies and developes promising personalized medicine technologies, has validated and is now offering Next Generation Sequencing services.

While NGS is applied across the full spectrum of biological research, it’s having its greatest impact in cancer research and treatment. It enables the timely study of the genetics of particular strains of cancer, which increases the precision with which physicians can treat individual patients.

“That’s why we started with a panel that looks at 24 known cancer-associated genes,” says Dr. Kevin Goudy, director of R&D for PGXL Technolgies. “This is making a big difference fast.”

The NGS complements PGXL Tech’s existing single-cell isolation capability. Together, they provide cell-specific identification with complete phenotypic and genotypic breakdown.

CLICK HERE for additional Information.

 

by Tom Johnson

CAP Accreditation

Downloaded LogoPGXL’s expanded lab has been accredited by the College of American Pathologists (CAP) after an exacting period of preparation and inspection. PGXL is now both CLIA and CAP certified, testament to our lab staff’s meticulous dedication.

by Tom Johnson

PGXL Software Cleared for Clinical Trials

PeRMIT Warf Logo 541PGXL’s PerMIT software has received regulatory clearance for a clinical trial involving up to 720 patients.

PerMIT:Warfarin is a decision support software that provides a graphic display of historical and projected aspects of warfarin therapy. It analyzes genetic and other data to provide information physicians can apply in the dosing and monitoring of the most commonly prescribed anticoagulant.

An earlier, small study of PerMIT indicated that use of the software got patients to therapeutic stability in a shorter time than those treated without the software. This new clinical trial is designed to determine whether the software reduces the risk of adverse drug reactions in real-world therapy.

To read more about the PerMIT:Warfarin clinical trial, CLICK HERE.

by Tom Johnson