Anaphylaxis

FDA: Lifted Label Defect May Delay Emergency Treatment With EpiPen

By November 05, 2018

To ensure that the auto-injector can be easily removed from the carrier tube, healthcare providers should inspect the product prior to dispensing.

Expiration Dates Extended for Certain Lots of Generic Adrenaclick

By October 26, 2018

Epinephrine auto-injectors are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis.

BLA for Novel Peanut Allergy Treatment Submitted to FDA

By October 22, 2018

Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization.

Additional Symjepi Dosage Strength Approved for Anaphylaxis Treatment

By September 28, 2018

Both doses will be supplied in single-dose, prefilled syringes for manual injection.

Veta Smart Case, App for Epinephrine Auto-Injectors Now Available

By September 06, 2018

The Smart Case includes electronics and sensors to monitor the proximity, temperature, presence and removal, and expiration of auto-injectors.

Walgreens to Offer Auvi-Q Nationwide in an Effort to Address Epinephrine Supply Issues

By September 06, 2018

This effort is in response to epinephrine auto-injector supply issues reported by manufacturers to the Food and Drug Administration (FDA).

Novel Epinephrine Nasal Spray for Anaphylaxis Gets Fast Tracked by FDA

By August 31, 2018

The bioavailability of the novel epinephrine nasal spray also proved similar to that of intramuscular injection with EpiPen 0.3mg injection.

FDA Extends Expiration Date for Certain Lots of EpiPen

By August 21, 2018

This date modification beyond the approved 20-month shelf life was based an FDA review of product stability data submitted by Mylan.

First Generic Version of EpiPen Gets FDA Approval

By August 16, 2018

Unlike other generic approvals, epinephrine auto-injectors are considered "combination products" because they consist of both a drug and a device, making the approval process more challenging.

Manufacturers Issue Statements Regarding Epinephrine Auto-Injector Supply

By August 15, 2018

In May, the Food and Drug Administration posted a drug shortage alert, adding Mylan's EpiPen (epinephrine injection) to the drug shortage list.

Xolair Designated Breakthrough Therapy for Food Allergies

By August 13, 2018

The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).

FDA Announces New Drug Shortages Task Force

By July 12, 2018

Gottlieb said "The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these [drug] shortages."

Most Adults Don't Use Their Epinephrine Auto-Injectors During Reactions

By June 21, 2018

Most adults (52%) reported that an EAI was not used during their most severe reaction, even though it would have been beneficial, 45% said they didn't have it with them at the time.

Intranasal Epinephrine for Anaphylaxis Looks Promising in Early Study

By June 14, 2018

The pharmacokinetics trial, which included 60 participants with seasonal allergies, also demonstrated rapid drug absorption with the intranasal spray.

Concerns Over EpiPen Supply Prompt Statement from Mylan

By May 09, 2018

Intermittent supply constraints due to manufacturing delays from Mylan's manufacturing partner, Meridian Medical Technologies, have resulted in varying supply levels.

Auvi-Q 0.1mg Auto-Injector Available Soon for Infants, Toddlers

By April 26, 2018

The supplemental New Drug Application (sNDA) for the 0.1mg strength was granted Priority Review by the Food and Drug Administration (FDA).

Pathway modification reduces admissions for pediatric anaphylaxis

April 11, 2018

Inpatient and observation unit admissions for pediatric anaphylaxis decreased by more than half following implementation of a revised clinical care pathway.

Death After Bee Venom Apitherapy in Previously Tolerant Patient

By March 21, 2018

In this case, a 55-year-old woman developed wheezing, dyspnea, and sudden loss of consciousness during her apitherapy session in which she received live bee stings to improve muscular contractures and stress.

Symjepi vs EpiPen: Incorrect Usage Rates Among Untrained Teens

By March 08, 2018

The study enrolled 34 adolescents aged 12 to 17 years old who had no familiarity with an epinephrine device (naive) and did not receive training during the study.

Peanut Allergy Oral Immunotherapy Effective in Phase 3 Study

By February 21, 2018

With regard to adverse events, 12.4% of AR101-treated patients discontinued treatment due to treatment-related side effects; these included gastrointestinal adverse events (6.7%) and systemic allergic hypersensitivity reactions (2.7%).

Survey: Most At-Risk Patients Don't Carry Two Epinephrine Auto-Injectors

By February 08, 2018

Most respondents did not carry 2 EAIs in order to keep 1 EAI in another location.

Varubi Labeling Updated to Warn of Serious Hypersensitivity Reactions

By January 16, 2018

Anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported.

New Flu Vaccine Guidelines Issued for Patients With Egg Allergy

By December 19, 2017

The updated parameter stresses that no special precautions are needed or recommended for those with egg allergy.

Auvi-Q 0.1mg Auto-Injector Approved for Infants, Small Children

By November 20, 2017

Auvi-Q 0.1mg is the first epinephrine auto-injector specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 pounds.

Researchers Develop Portable Food Allergen-Detection System

By September 07, 2017

Most products were accurate to their stated label, however most products did contain at least 1 unspecified antigen, for instance, "brand of nut-free cookies contained gluten, whereas a gluten-free brand contained a peanut allergen," the authors write.

Peanut Allergy Tx Efficacy Examined in 4-Year Follow-Up Study

By August 17, 2017

Results found that 4 children initially treated with PPOIT and 6 treated with placebo had allergic reactions to peanut intake, none experience prophylaxis.

FDA: Severe Hypersensitivity, Death Following Curcumin Injection

By August 04, 2017

In March and May 2017, two patients given intravenous (IV) infusions of curcumin emulsion compounded with polyethylene glycol (PEG) 40 castor oil reported having immediate hypersensitivity reactions.

Epinephrine Auto-Injector for Infants, Small Children Gets Priority Review

By July 27, 2017

The company has indicated that if the new auto-injector is approved they expect it to be available for patients in the first half of 2018.

Delayed Anaphylaxis Treatment Often Occurs in Children

July 13, 2017

The researchers found that 36.3% of the children received epinephrine before arrival at the emergency department or UCC.

Vitamin D Supplementation Assessed for Preventing Allergic Diseases

July 12, 2017

The researchers found that based on very low certainty in the body of evidence across examined studies, vitamin D supplementation may not reduce the risk of developing allergic diseases.