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Study Finds Proton Pump Inhibitors May Increase First-Time Ischemic Stroke Risk

By | Adverse Drug Reactions, Provider | No Comments

Use of proton pump inhibitors (PPIs) is associated with an increased risk of first stroke, according to data presented at the November 2016 American Heart Association Scientific Sessions in New Orleans.

 

The study found that overall stroke risk increased 21% among patients who were taking a PPI. While at the lowest doses, the authors found either no or minimal increased risk of stroke, at the highest doses, they found that stroke risk increased 33% for Prilosec and Prevacid patients, 50% for Nexium patients and 79% for Protonix patients.

 

“Considering the wide use of proton pump inhibitors worldwide, our study further questions the cardiovascular safety of these drugs and further studies are warranted,” the study’s authors concluded.

 

In a related study, the authors likewise found that PPIs carry a significant risk of other adverse effects, being specifically linked to an increased risk of bacterial infection. Other complications include an increased risk of kidney failure.

 

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Clozaril Black Box Warning

By | Antipsychotics, Provider, Psychiatric Medications | No Comments

Clozaril (generic name clozapine) is an atypical antipsychotic approved to treat schizophrenia. The drug is also used “off-label” to treat bipolar disorder and schizoaffective disorder. While it can be effective in treating the symptoms of schizophrenia, the drug may cause severe and sometimes life-threatening side effects.

 

FDA “Black Box” Warning for Numerous Side Effects

 

Certain Clozaril side effects are so harmful to the person, that they have prompted a special warning by the FDA called a “black box” warning. In fact, clozapine has five black box warnings:

 

  • Agranulocytosis
  • Seizures
  • Myocarditis and cardiomyopathy
  • Orthostatic hypotension, bradycardia, syncope
  • Increased risk of death in elderly patients with dementia

 

Agranulocytosis

 

Agranulocytosis is a disorder of the blood in which there are too few white blood cells. This side effect of clozaril is also referred to as neutropenia. White blood cells are a key component of the immune system. As such, people with neutropenia are at an increased risk for infections. This side effect of clozapine is with such seriousness, that people who receive clozapine must have their blood tested for neutropenia periodically. In fact, clozapine is only available through a distribution system that ensures blood monitoring. If neutropenia does occur, clozapine is stopped and white blood cell count returns to norm level.

 

Seizures

 

One of the major neurological Clozaril side effects is seizures. Seizures are abnormal increases in brain activity that may lead to uncontrollable physical movements, convulsions, and loss of consciousness. People who have a history of seizures, have epilepsy, or any condition in which seizures may occur, are often not able to take clozapine because of this ornery physical reaction.

Clozapine lowers the seizure threshold. This effect seems to be dose dependent. In other words, the risk of seizure increases as the dose of Clozaril increases.

 

Myocarditis and Cardiomyopathy

 

Myocarditis and cardiomyopathy are related conditions that involve inflammation of the heart and cause damage to the heart muscle. These conditions can be fatal. Clozaril adverse effects are more likely to occur within the first month of starting the drug. There is a small risk of myocarditis and cardiomyopathy at any point when the drug is use. If signs or symptoms of the Clozaril side effects occur, talk to your doctor and stop taking the medication.

 

Orthostatic Hypotension, Bradycardia, Syncope

 

These clozapine adverse effects are interrelated. The drug may decrease both heart rate and blood pressure, especially when someone rises from a seated or reclining position. When there is not enough blood flow to the brain, patients may become lightheaded (pre-syncope) or actually faint (syncope). These Clozaril side effects are most likely to occur when the drug is started or the dosage is changed.

 

Increased Risk of Death in Elderly Patients with Dementia

 

Atypical antipsychotics (including Clozaril), increase the risk of death in elderly patients with dementia. Dementia is a condition that causes hallucinations and delusions. As such, clozapine is usually not used to treat dementia-related psychosis.

 

Other Clozaril Side Effects

 

Compared to black box warnings, other Clozaril side effects are relatively minor. The most common Clozaril adverse effects are tachycardia (rapid heart rate), drowsiness, dizziness, insomnia, weight gain, nausea, vomiting, constipation, and sialorrhea (drooling or excessive saliva production).

 

To have an understanding on how you will react to Clozaril, preferably before using it, PGx testing with Rxight® can provide the solution. The Rxight® panel also includes hundreds of other medications across over 50 pharmacological classes.

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The Pharmacogenomics of Statins in Assessing Individual Potential for Adverse Effects

By | Adverse Drug Reactions, Provider | No Comments

A September 2016 article in Pharmacogenomics and Personalized Medicine (Joseph Kitzmiller, et al) discussed the pharmacogenomics of statins as applied to individual susceptibility to side effects from statin pharmacotherapy. Statins are the most commonly prescribed medications for treatment and prevention of atherosclerotic disease in the U.S. and Europe. Adverse effects from statins – including myopathy (experienced in 1 out of 10 of patients), liver toxicity, and central nervous system toxicity – are a significant factor in patient non-compliance and discontinuation of therapy, the article states.

 
Pharmacogenomics can provide significant insight into an individual’s risk of statin adverse effects. According to the article, genetic polymorphism affect statin pharmacokinetics directly, affecting risk of statin toxicity in susceptible patients, particularly with concomitant use of medications that inhibit CYP3A metabolism. The article notes that there is a “paucity of research investigating CPY3A polymorphism and statin toxicity,” callings for future pharmacogenetic research incorporating a multi-polymorphism and multigene arrays to perform a better risk-benefit analysis of statin pharmacotherapy.

 

Rxight®  pharmacogenetic testing assesses the patient’s potential for side effects from clinically relevant and commonly prescribed agents (including atorvastatin (Lipitor)), fluvastatin (Lescol), lovastatin (Mevacor Altocor, Altoprev), pitavastatin (Livalo), pravastatin (Pracachol), rosuvastatin (Crestor) and simvastatin (Zocor). With Rxight® the patient and their prescriber can evaluate the likelihood of side effects, preferably before statin therapy commences, and thus find a safe dose or alternative medication.

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Economic Support for Broadening Pharmacists’ Clinical Role in Laboratory Testing

By | Announcements, Provider | No Comments

Kudos to Timmons and Norris for their paper on the economic support for broadening pharmacists’ clinical role, especially as it relates to laboratory testing: CLIA Waiver Pharmacy Growth: How Does Broadening Scope of Practice Affect the Pharmacist Labor Market?

 

Pharmacists have an important role in the healthcare field. Their functions and responsibilities range from dispensing medications to performing Medication Therapy Management sessions (MTMs). In most states, pharmacists will also collaborate with physicians and provide care for their patients, which frees up time for physicians, brings business to the pharmacy and most importantly ensures the highest quality of health care that a patient can receive. Sometimes that also includes ordering a lab test at the pharmacy when necessary.

 

With a reported reduction in Primary Care Physicians in the near future and with many pharmacies already ordering lab tests on site, it makes sense to expand the role of the pharmacist to include ordering pharmacogenetic tests for those patients that could benefit from it. Since pharmacists are the experts in drug-drug and drug-gene interactions (and are now being taught pharmacogenetics as part of their PharmD education), this is something that would be a natural fit for them. Burdening the physicians for an authorization of a simple cheek swab is not only inefficient, but could also lead to the patient not getting access to a pharmacogenetic test and potentially being on the wrong medication or wrong dosage. Significant time and money could be saved and better health outcomes could be achieved, by allowing pharmacists to order a pharmacogenetic test.

 
With all of these factors taken into consideration, there is a strong case for allowing pharmacists to order pharmacogenetic testing when the processes are in place to mitigate risks to the patient. Such mitigating factors would include a pharmacogenetic counseling session between the patient and pharmacist, alerting prescribers up-front that their patient has chosen PGx testing, and communicating genetic implications as it relates to medication therapy to all relevant prescribers.
 
Denis Grizelj
Co-Founder MD Labs

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Genetic Testing for Depression

Using PGx Testing to Optimize Clomipramine Dosing in Major Depression

By | Precision Medicine, Provider | No Comments

 

An October 2016 article in the Journal of Clinical Pharmacy and Therapeutics , “The combination of pharmacogenetic and pharmacokinetic analyses to optimize clomipramine dosing in major depression: a case report,” discusses the application of pharmacogenetic and pharmacokinetic analyses to assess the dosing of clomipramine to achieve therapeutic benefit in a clomipramine non-responder. In the study, a female patient with refractory major depression underwent pharmacogenetic testing to analyze her need for higher than normal doses of clomipramine. Specifically, PGx testing revealed polymorphisms in cytochrome P450 2D6 and 2C19 leads to interindividual differences in drug plasma concentrations, affecting clomipramine efficacy. The article concluded “[t]herapeutic drug monitoring and pharmacogenetic analyses may be useful in the investigation and optimization of clomipramine in standard-dose non-responders.”

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Pharmacogenetics for Physicians

By | Concierge Medicine, Precision Medicine, Provider | No Comments

Practicing physicians make decisions throughout the day about how to treat a patient’s medical disorders based on experience and expertise. Prescription medications are often part of a comprehensive wellness program. Doctors know that certain medications are sometimes associated with side effects, or conversely, that a patient may not get any therapeutic benefit from a drug. Variations in patient responses to medications have been known for many years. To minimize the potential for adverse reactions, physicians may elect to begin a drug therapy program using a low-dose, trial and error method. Advances in molecular genetics and biochemistry have shown genetic variants can have an effect on the production and actions of drug metabolizing enzymes.

 

Pharmacogenetics and Drug Response

 

Pharmacogenetics examines the way genetic differences affect drug response. Research has demonstrated the correlation of certain genetic variants with the way specific drugs are metabolized. These differences can affect drug responses and drug interactions. Some are well documented, such as a high potential of developing a hypersensitivity reaction to abacavir by individuals who carry variant HLA-B*57:01. Genetic testing for this gene variant is now standard before prescribing abacavir.

 

Another example is warfarin, a commonly prescribed anticoagulant. Warfarin is associated with adverse drug reactions such as increased risk of bleeding in people with CYP2C9 and VKORC1 variants. The FDA has issued dosage guidelines and recommends genetic testing before prescribing warfarin.

 

The cytochrome P450 enzymes are responsible for the metabolism of more than 70 percent of all prescription drugs. CYP2D6 is associated with the metabolism of approximately 25 percent of commonly prescribed drugs. It has more than 100 known variants that affect metabolism of many classes of drugs including psychotropic medications, beta blockers and analgesics such as pro-drugs codeine and tramadol.

 

People who carry variants of CYP2D6 may be at risk for adverse side effects from opioids. Poor metabolizers may not get any pain relief from codeine or tramadol. Ultra-rapid metabolizers have a higher incidence of adverse effects and toxicity with codeine because it is rapidly converted to morphine.

 

Clinical Applications of Pharmacogenetics for Prescribers

 
Genetic testing provides important information about pharmacogenetics for physicians. Pharmacogenetics can help prescribers select an appropriate drug therapy that has the potential to reduce adverse reactions, predict optimal doses and determine efficacy. Standard dosing algorithms include age, sex, medical condition, weight and use of other drugs. Including a patient’s genotype in the algorithm can help determine optimal dosing for drugs that have known genetic associations.

 
Pharmacogenetic testing involves collecting DNA samples from a cheek swab to determine whether a patient has genetic variants that affect drug metabolism. Samples are analyzed by MD Labs using open array technology. MD Labs is certified by Clinical Laboratory Improvement Amendments (CLIA) for pharmacogenetic testing. The Rxight test examines 60 alleles on 18 genes that are involved with the metabolism of more than 200 prescription and over-the-counter drugs.

 

The test includes a Personalized Medication Review® that is explained to the patient by a pharmacist trained in pharmacogenetics. Patients can keep results of testing on file with the pharmacist, who will coordinate medication and dosing recommendations with the clinician. Because a person’s genetic characteristics do not change, the test does not need to be repeated.

The Precision Medicine Initiative

By | Precision Medicine, Provider | No Comments

Over the past 50 years, there has been a growing “one size fits all” attitude to practice in medicine. Diseases are treated as happening to a patient, and each disease has a specific treatment. But this overlooks the variability in individuals, and there has been a recent push back towards putting individual patients at the centre of care. This was highlighted in 2015, when President Barack Obama announced The Precision Medicine Initiative. This initiative hopes to push individualized medicine into the mainstream, powering $215 million of research into pioneering new research and technologies.

 

Individualized medicine relies on the principle of interperson variability. Each patient is different, and as such should be treated differently. Each patient has a genetic code, which is different in every individual and defines everything from what they look like to how they metabolize drugs. It has long been noted that many patients react differently to the same drug. A number of factors can affect this although the major one is the patient’s genetics.

 

In 1954 the field of Pharmacogenetics was born when two German physicians noticed variable reactions to the anti-TB drug Isoniazid. This difference was caused by the different genetics of patients. Each gene has variations, or polymorphisms, between individuals that affect the function of the protein that is built from that genetic code. In some individuals, these polymorphisms mean they metabolize certain drugs slowly or not at all. An example of this is the gene CYP2D6, the protein to which it makes turns codeine into its active form morphine. Some individuals metabolize codeine slowly or not at all, meaning they never produce the active analgesic (anti pain medication) morphine. These patients exhibit no pain relief from codeine.

 

This simple example of codeine metabolism can be extrapolated to hundreds of drugs and genes. This is what MD Labs achieves with Rxight®. We sequence many genes and identify polymorphisms that are likely to affect the action of over 200 drugs. From this physicians and pharmacists can produce a picture of how a patient is likely to respond to certain treatments. This allows them to choose the right medication, the first time.

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Rxight® Featured in Pharmacy Times Magazine

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The Role of Pharmacogenetics in Precision Medicine. An overview of the science of pharmacogenetics and discussion of the clinical utility of PGx testing in obviating the prevalence of medication non-response and adverse effects as determined by individual variation in genetically mediated response to medications. Li Gong, PhD; Michelle Whirl-Carrillo, PhD; and Teri E, Klein, PhD.

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