‘Certain’ Tagged Posts

Expiration Dates Prolonged for Sure A lot of Generic Adrenaclick

Expiration date for specific lots will be increased from 18 months to 20 months The expiration dates for certain lots of epinephrine injection, USP au...

Expiration date for specific lots will be increased from 18 months to 20 months

Expiration date for specific lots will be increased from 18 months to 20 months

The expiration dates for certain lots of epinephrine injection, USP auto-injector 0.15mg and 0.3mg (Impax Laboratories), the authorized generic of Adrenaclick, have been extended by 2 months after the Company coordinated with the Food and Drug Administration (FDA) to address the ongoing drug shortage.

Epinephrine auto-injectors are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis. The expiration dates of these lots have been increased from 18 months to 20 months; the full list can be viewed here.  “This announcement is made after a comprehensive evaluation of data to enable the extension of the expiration date on specific lots,” said Joseph Greer, SVP, Global Quality Management, in a press release. 

FDA Extends Expiration Date for Sure Plenty of EpiPen

The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The FDA emphasized that these products should continue to be stored as directed on the label to ensure patient safety

The Food and Drug Administration (FDA) has extended the expiration date of certain lots of Mylan’s EpiPen (epinephrine) Auto-Injector 0.3mg by 4 months past the labeled date. 

This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan. Several factors contributed to the product’s limited availability in certain areas of the US, including regional supply disruptions and manufacturer issues. Specifically, Mylan cited intermittent supply constraints due to manufacturing delays from their partner, Meridian Medical Technologies, a subsidiary of Pfizer. Continual supply from Meridian is still ongoing and Mylan is expediting shipment to wholesalers upon receipt. Meridian also manufactures EpiPen Jr 0.15mg Auto-Injectors and the authorized generic versions of these strengths. 

The full list of EpiPen Auto-Injectors and Epinephrine Injection, USP Auto-Injectors 0.3mg with extended expiration dates can be found here. Patients with product from these batch numbers will be able to use them through the new use dates provided.

“We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring. We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

Off-Label Prescribing Widespread With Sure Psychiatric Drugs


July 26, 2018

Antidepressants made up the majority of prescriptions for off-label use

Antidepressants made up the vast majority of prescriptions for off-label use

Psychiatric drugs are sometimes prescribed for circumstances for which they haven’t been accepted for by the Meals and Drug Administration (FDA), based on a brand new examine printed in PLOS ONE.

For this examine, researchers aimed to establish the prevalence and predictors of off-label prescribing utilizing knowledge from the 2012 and 2013 Nationwide Ambulatory Medical Care Surveys (NAMCS). They checked out all grownup outpatient visits to psychiatric practices for power care administration during which ≥1 psychiatric medicine was prescribed; a complete of 18.5 million (1.three%) visits of the general pattern of 1.85 billion visits included ≥1 psychiatric drug prescription. An evaluation of those prescriptions confirmed that 12.9% (95% CI: 12.2-15.7) have been for off-label makes use of. 

Antidepressants made up the vast majority of prescriptions for off-label use (52.2%), as they have been probably the most generally prescribed, however stimulants and antipsychotics have been related to the very best charges of off-label prescription (17.6% and 17.four%, respectively).  Manic-depressive psychosis handled with citalopram (75.9% of off-label use) and insomnia handled with trazodone (54.eight% of off-label use) have been discovered to be the most typical off-label makes use of.

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With regard to the traits related to off-label use, seeing a psychiatrist as a substitute of one other sort of clinician (P=.03), being within the Western area of the US (P=.02), and having ≥three power non-psychiatric circumstances (P=.003) have been all positively linked with receiving an off-label prescription. Conversely, having Medicare protection (P=.04) and receiving cost help from a medical charity (reasonably than a non-public insurer) (P=.03) have been negatively related to off-label prescribing.

The authors concluded that “inspecting charges and traits of off-label use in particular therapeutic areas, similar to psychiatry, and finding out predictors of off-label use, can form future regulatory coverage and inform medical guideline suggestions.” They added that future research ought to have a look at methods to “implement post-market pharmacovigilance as a way to reduce hostile drug reactions and guarantee affected person security and optimum well being outcomes.”

For extra info go to Plos.org.

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Incidence of Extrapyramidal Signs Larger With Sure Antidepressants


June 18, 2018

Researchers conducted a nested case-control study using a large US health claims database.

Researchers performed a nested case-control examine utilizing a big US well being claims database.

The usage of sure antidepressants could put sufferers at elevated danger for extrapyramidal signs (EPSs), based on a big pharmacoepidemiologic examine printed within the Journal of Medical Psychopharmacology.

In an effort to quantify the affiliation between numerous antidepressant lessons and EPSs, researchers performed a nested case-control examine utilizing a big US well being claims database from June 2006 to December 2015.  Instances have been outlined as those that obtained their first billing code for EPSs (secondary Parkinson illness [PD], associated drug-related EPSs) any time in the course of the enrollment interval. Sufferers who obtained a analysis of major PD or important tremor, or these taking anti-PD medication, typical and atypical antipsychotics, tricyclic antidepressants, diphenhydramine, or metoclopramide at any time in the course of the follow-up interval have been excluded. Every case was then matched to 10 controls and price ratios (RR) have been calculated utilizing conditional logistic regression.

Inside the cohort, 3838 instances have been recognized and in contrast with 38,380 age-matched controls. Outcomes confirmed that duloxetine had the best EPS RR (5.68; 95% CI, four.29–7.53) adopted by mirtazapine (three.78; 95% CI, 1.71–eight.32), citalopram (three.47; 95% CI, 2.68–four.50), escitalopram (three.23; 95% CI, 2.44–four.26), paroxetine (three.07; 95% CI, 2.15–four.40), sertraline (2.57; 95% CI, 2.02–three.28), venlafaxine (2.37; 95% CI, 1.71–three.29), bupropion (2.31; 95%CI, 1.67–three.21), and fluoxetine (2.03; 95%CI, 1.48–2.78). 

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Given the statistically vital affiliation noticed between these antidepressants and EPSs, the authors concluded that for sufferers with motion issues who require antidepressant remedy, clinicians could wish to take into account sertraline, venlafaxine or fluoxetine. 

For extra data go to journals.lww.com.

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FDA: Attainable Danger of Neural Tube Delivery Defects With Sure HIV Meds

Dolutegravir is an HIV-1 integrase strand transfer inhibitor

Dolutegravir is an HIV-1 integrase strand switch inhibitor

The Meals and Drug Administration (FDA) has issued a security communication concerning the potential danger of neural tube delivery defects related to dolutegravir, an antiretroviral agent accredited to deal with HIV an infection. 

The Company has acquired reviews of significant neural tube delivery defects involving the mind, backbone, and spinal wire in infants born to ladies who acquired dolutegravir for HIV therapy. Preliminary findings from an observational research in Botswana confirmed that girls handled with dolutegravir on the time of turning into pregnant or early within the first trimester gave the impression to be at elevated danger for these delivery defects; no instances of infants born with neural tube defects have been reported amongst ladies who began dolutegravir later in being pregnant. 

Dolutegravir, an HIV-1 integrase strand switch inhibitor (INSTI), is indicated together with different antiretrovirals, to deal with HIV an infection. It’s out there beneath the model identify Tivicay (ViiV Healthcare) in addition to in a fixed-dose mixture with different antiretrovirals beneath the model names Juluca (dolutegravir, rilpivirine; ViiV Healthcare) and Triumeq (abacavir, dolutegravir, lamivudine; ViiV Healthcare).

In gentle of those reviews, the FDA recommends that clinicians ought to weigh the advantages and dangers of dolutegravir when prescribing antiretrovirals to ladies of childbearing age; the dangers and advantages of other therapies also needs to be thought of. Girls of childbearing age ought to use efficient contraception if the choice to make use of dolutegravir is made. As well as, being pregnant testing needs to be performed in ladies of childbearing age to exclude being pregnant earlier than beginning therapy with dolutegravir.

The FDA is constant to analyze the protection danger and can replace the general public when extra info is obtainable.