Showing posts with label naloxone (Narcan). Show all posts
Showing posts with label naloxone (Narcan). Show all posts

Thursday, January 17, 2019

Naloxone - FDA clears the way to increase access and lower cost

In The News
FDA clears the way to increase access and lower cost of life-saving opioid overdose treatment drug
-Naloxone is used in emergency rooms across the U.S. to reverse a drug overdose from opioids.
-The FDA is streamlining the labeling for naloxone.
-The change clears the way for drugmakers to sell it without a prescription.

FDA Press Release
Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths
SILVER SPRING, Md., Jan. 17, 2019 /PRNewswire/ -- With the number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017, it's critical that we continue to address this tragedy from all fronts. This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

When someone overdoses on an opioid, the person may lose consciousness and breathing may become shallow or stop. This can rapidly lead to death if there's no medical intervention.

However, if naloxone is administered quickly, it can counter the overdose effects, usually within minutes. While the person administering naloxone should also seek immediate medical attention for the patient, the bottom line is that wider availability of naloxone and quick action to administer it can save lives.

Naloxone is a critical drug to help reduce opioid overdose deaths. Prevention and treatment of opioid overdose is an urgent priority. Increased availability of naloxone for emergency treatment of overdoses is an important step. One potential way to improve access to naloxone is to make it available for over-the-counter (OTC) sale. FDA-approved versions of naloxone currently require a prescription, which may be a barrier for people who aren't under the care of a physician or may be ashamed or even fearful of admitting to issues with substance abuse. Having naloxone widely available, for example as an approved OTC product, is an important public health advance, and a need that we've been working on at the FDA.

Although FDA-approved prescription naloxone formulations have instructions for use in product labeling, they don't have the consumer-friendly Drug Facts label (DFL), which is required for OTC drug products. Before submitting a new drug application or supplement for an OTC drug product, companies must develop a DFL and conduct studies to show that consumers can understand how to use the product without the supervision of a health care professional. Some stakeholders have identified the requirement to perform these studies as a barrier to development of OTC naloxone products.

To encourage drug companies to enter the OTC market and increase access to naloxone, the FDA took an unprecedented step: we developed a model DFL with easy-to-understand pictograms on how to use the drug. We also conducted label comprehension testing to ensure the instructions were simple to follow.

This is the first time the FDA has proactively developed and tested a DFL for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients. One of the key components for OTC availability is now in place. In short, we've crafted model labeling that sponsors can use to obtain approval for OTC naloxone and increase its access. This action was part of our broader commitment to addressing the opioid crisis.

Today, we're announcing the results of our work, including posting two model DFLs (one for use with a nasal spray and one for use with an auto-injector) and the supporting FDA review. These efforts should jumpstart the development of OTC naloxone products to promote wider access to this medicine. The model DFL contains the information (except for individual product-specific information) that a consumer needs to administer naloxone safely and effectively.

During this period without a FY19 appropriation for the FDA, we've been focused on making sure that we continue critical aspects of our work, to the extent permitted by law. At this time, for products (such as naloxone) that are covered by a user fee program, our review of existing medical product applications and associated policy development regarding our review are funded by limited carryover user fee balances. We'll continue to update the public on how we're approaching our work during the lapse in appropriations.

Consumer comprehension of the model DFL was iteratively tested by an independent research contractor in a prespecified research design involving over 700 participants across a wide range of potential OTC naloxone users. This included people who use heroin; people who use prescription opioids; family and friends of people who use opioids; adolescents; and the general public. An FDA review team not directly involved in the conduct of the study independently reviewed the study report and determined that the comprehension results were satisfactory. Overall, the study demonstrated that the model DFL was well-understood by consumers and is acceptable for use by manufacturers in support of their OTC naloxone development programs. Using this information, naloxone manufacturers can now focus their efforts on final label comprehension testing of how well consumers understand the product-specific information that hasn't been already tested in the model DFL. I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.

The model DFL comes in two versions. One is for use with a nasal spray and one for use with an auto-injector. But the product-specific instructions in each version are placeholders that have not been tested by the FDA for comprehension or human factors performance. Sponsors can replace these placeholders with their own product-specific information and test it if necessary. Apart from this product-specific information, the model DFL otherwise contains all the key information needed for an untrained bystander to administer naloxone. In designing the model DFL, the FDA team sought input from multiple stakeholders in the addiction care community, as well as from the FDA internal experts, to streamline the DFL to contain only the most critical information, so that it could be easily understood in an emergency. We're grateful to the hundreds of study participants who helped us see this DFL through their eyes, which enabled us to refine the DFL multiple times until we reached a final version. These research participants enabled these efforts.

This work builds on our ongoing efforts to get this life-saving drug into the hands of those who need it most. In addition to the approval of injectable naloxone for use in a health care setting and both prescription auto-injector and intranasal forms of naloxone, which facilitate use by laypersons, we also released draft guidance to advance development of generic naloxone hydrochloride nasal spray.

Additionally, we also held a two-day advisory committee meeting last month to solicit input and advice on strategies to increase the availability of naloxone products intended for use in the community. We asked our external advisors from the FDA's Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options for increasing access to naloxone.

As part of HHS' ongoing efforts to combat the opioid crisis and expand the use of naloxone, in April 2017, the Department announced its 5-Point Strategy to Combat the Opioids Crisis. Those efforts include: better addiction prevention, treatment, and recovery services; better data; better pain management; better targeting of overdose reversing drugs; and better research. In April 2018, Surgeon General VADM Jerome Adams issued an advisory encouraging more individuals, including family, friends, and those who are personally at risk for an opioid overdose to carry naloxone. In December 2018, Adm. Brett P. Giroir, MD, Assistant Secretary for Health and the Secretary's Senior Advisor for Opioid Policy, released guidance for health care providers and patients detailing how naloxone can help save lives.

We're taking many steps to improve availability of naloxone products and we're committed to working with other federal, state and local officials; health care providers; patients; and communities across the country to combat the staggering human and economic toll created by opioid abuse and addiction.

For More Information:
FDA: Information about Naloxone

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sarah Peddicord, 301-796-2805,
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration

Wednesday, June 6, 2018

FDA Recall: Opioid Antidote Naloxone

FDA: Opioid Antidote Naloxone Recalled
TUESDAY, June 5, 2018 (HealthDay News) -- A recall of the opioid overdose antidote Naloxone was announced Monday. The U.S. Food and Drug Administration said the recall was triggered by the possibility of "loose particulate matter on the syringe plunger" that could pose a number of health risks, CNN reported.

Those risks include "local irritation, allergic reactions," and a range of cardiovascular issues, including blood clots, according to the FDA. The agency has not received any reports of patient harm from the recalled Naloxone, made by Hospira.

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

In the event that impacted product is administered to a patient, the patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity. The risk is reduced by the possibility of detection, as the labeling contains a clear statement directing visual inspection of the product for particulate matter and discoloration prior to administration. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Naloxone Hydrochloride, an opioid antagonist, is indicated for the complete or partial reversal of opioid depression. It is also indicated for the diagnosis of known or suspected opioid overdosage, and as an adjunctive agent for the management of septic shock. It is available as a sterile solution for intravenous (IV), intramuscular (IM), and subcutaneous (SC) administration. Naloxone is supplied in a Carpuject single-use cartridge with a 1 mL fill for use with the Carpuject syringe system.
The NDC, Lot Number, Expiration Date, Strength and Configuration details for Naloxone Hydrochloride Carpuject Injection is indicated below. Product lots were distributed nationwide to wholesalers/distributors/hospitals in the United States, Puerto Rico, and Guam from February 2017 to February 2018.
NDC Number Date Strength Configuration/Count
(Single Unit)
72680LL 1DEC2018 0.4 mg/mL
1 mL in 2.5mL
10-1 mL Single Use Carpuject&trad;
(Sterile Cartridge Unit with
Luer Lock) per box/carton; 100 boxes/cartons per case (1000)
76510LL 1APR2019 0.4 mg/mL,
1 ml in 2.5 mL

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals to arrange for return of any recalled product.

Distributors or retailers with an existing inventory of the lots, which are being recalled, should stop use and distribution and quarantine immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the below information.
Contact Contact Information Areas of Support
Pfizer Medical
1-800-438-1985, option 3
(8am to 7pm ET Monday through
Medical Inquiries
Pfizer Safety 1-800-438-1985, option 1 (24
Hours a day 7 days per week)
To report adver
Events or product

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Adverse events or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
Complete and submit the report Online:
Regular Mail or Fax: download form or call 1-800-FDA-1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Monday, May 7, 2018

Reversing An Overdose Isn't Complicated, But Getting The Antidote Can Be

Of Interest
Should you carry the opioid overdose rescue drug naloxone?
Posted May 04, 2018, 6:30 am , Updated May 07, 2018, 11:57 am
Scott Weiner, MD
I would answer “yes” but with some qualifiers. As the Surgeon General wrote, naloxone is most effective for people taking high doses of opioids, who are misusing prescription opioids, or who are using illicit opioids. It makes sense to have naloxone on hand if you fall into one of these categories, or if you are a friend, family member, or community member who comes into contact with people at risk for overdose. You should also know that in most states, you can request naloxone at most pharmacies without a prescription.

Reversing An Overdose Isn't Complicated, But Getting The Antidote Can Be
May 7, 20185:01 AM ET
Jake Harper

Heard on Morning Edition
A few months ago, Kourtnaye Sturgeon helped save someone's life. She was driving in downtown Indianapolis when she saw people gathered around a car on the side of the road. Sturgeon pulled over and a man told her there was nothing she could do: Two men had overdosed on opioids and appeared to be dead.

"I kind of recall saying, 'No man, I've got Narcan,' " she says, referring to the brand- name version of the opioid overdose antidote, naloxone. "Which sounds so silly, but I'm pretty sure that's what came out."

Sturgeon sprayed a dose of the drug up the driver's nose, and waited for it to take effect. About a minute later, she says, the paramedics showed up.

View Article:

Friday, April 6, 2018

Listen: How to administer naloxone (Narcan) & How it can save a life of someone who overdoses on opioids

How naloxone can save life of someone who overdoses on opioids
March 30th, 2018

Listen here:

Naloxone, a medication that can reverse the effects of an opioid overdose, can be purchased over the counter from pharmacies in New York and several other states, says Willie Eggleston, a clinical toxicologist and doctor of pharmacy from the Upstate New York Poison Center. He explains how to administer naloxone, which is sold under the brand name Narcan, and how the medication works. He also tells about the Good Samaritan Law designed to protect people who are trying to help.

For more detailed information about naloxone, visit the New York State Department of Health website or this video (including demonstrations on how to administer naloxone, which starts at 44:37), from the SUNY University at Buffalo College of Pharmacy.

National Institute on Drug Abuse
April 5, 2018
Opioid Overdose Reversal with Naloxone (Narcan, Evzio) | National Institute on Drug Abuse (NIDA)

April 5, 2018
Surgeon General Urges More Americans To Carry Opioid Antidote
As opioid-related deaths have continued to climb, naloxone, a drug that can reverse overdoses, has become an important part of the public health response.

April 4, 2018
Nuala Sawyer
San Francisco has one of the lowest fatal-overdose rates in the U.S. Here's why.

March 30, 2018
If you or a loved one wants to beat an opioid addiction, first make sure you have a handy supply of naloxone, a medication that can reverse an overdose and save your life.

New England Journal of Medicine
March 29, 2018
Listen: Interview with Dr. Jake Liang on the increasing spread of hepatitis C virus associated with injection-drug use.

Hepatitis C in Injection-Drug Users — A Hidden Danger of the Opioid Epidemic
T. Jake Liang, M.D., and John W. Ward, M.D.
Much has been written about the escalating crisis of opioid-overdose deaths in the United States and its mounting social and economic costs. Although political and public health leaders have begun to confront this urgent problem, hidden beneath it lies another danger: the increasing spread of hepatitis C virus (HCV) associated with injection-opioid use
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