Today, the U.S. Food and Drug Administration approved RiVive, 3 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription use for the emergency treatment of known or suspected opioid overdose. This is the second nonprescription naloxone product the agency has approved, helping increase consumer access to naloxone without a prescription. The timeline for availability and the price of this nonprescription product will be determined by the manufacturer.
Drug overdose persists as a major public health issue in the United States. In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.
“We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health,” said FDA Commissioner Robert M. Califf, M.D. “The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA.”
The approval of RiVive nasal spray for nonprescription use was supported by data from a study submitted by the manufacturer that showed similar levels of RiVive reach the bloodstream as an approved prescription naloxone product. The drug has been demonstrated to be safe and effective for use as directed in its labeling. The manufacturer also provided data that showed consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.
The use of RiVive nasal spray in individuals who are dependent on opioids may result in severe opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.
The FDA has taken a series of steps to help facilitate access to opioid overdose reversal products and to decrease unnecessary exposure to opioids and prevent new cases of addiction. The agency approved the first nonprescription naloxone nasal spray product in March 2023, the first generic nonprescription naloxone nasal spray product in July 2023 and over the last year has undertaken new efforts to expand opioid disposal options in an effort to reduce opportunities for nonmedical use, accidental exposure and overdose.
Through the FDA Overdose Prevention Framework, the agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. The framework’s priorities include supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.
The FDA granted the nonprescription approval of RiVive to Harm Reduction Therapeutics.
- FDA Overdose Prevention Framework
- Information About Naloxone
- Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse
- Consumer Update: Access to Naloxone Can Save a Life During an Opioid Overdose
Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy
FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.
In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.
Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.
The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.
The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.
The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.
The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.
Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66
FDA Approves Updated mRNA COVID-19 Vaccines
FDA authorizes updated mRNA COVID-19 vaccines targeting circulating variants for enhanced protection.
In a significant move, the U.S. Food and Drug Administration (FDA) has taken action to approve and authorize updated COVID-19 vaccines that specifically target the currently circulating variants of the virus. These updated mRNA vaccines, manufactured by ModernaTX Inc. and Pfizer Inc., aim to provide better protection against severe outcomes, such as hospitalization and death, associated with COVID-19.
The updated vaccines have been formulated to include a monovalent component that corresponds to the Omicron variant XBB.1.5, based on comprehensive evidence and expert advice. The FDA’s decision reflects its confidence in the safety and effectiveness of these vaccines, with a clear benefit-risk assessment indicating that the benefits outweigh the risks for individuals aged 6 months and older.
Here’s what you need to know: Individuals aged 5 and older, regardless of their previous vaccination status, are eligible to receive a single dose of the updated mRNA COVID-19 vaccine, provided at least two months have passed since their last COVID-19 vaccine dose. For children aged 6 months to 4 years, the number and timing of doses depend on their previous vaccination history.
Unvaccinated children aged 6 months to 4 years are eligible to receive three doses of the updated Pfizer-BioNTech COVID-19 Vaccine or two doses of the updated Moderna COVID-19 Vaccine. Similar to previous mRNA vaccines, individuals may experience side effects as outlined in the respective prescribing information or fact sheets.
The updated vaccines are expected to offer robust protection against currently circulating variants, with the FDA suggesting that annual updates may be necessary, similar to the seasonal influenza vaccine. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will convene to discuss clinical recommendations and considerations for specific populations.
Manufacturers have announced that the updated vaccines will be available this fall, reinforcing the importance of vaccination in safeguarding public health. The FDA assures the public that these updated vaccines meet rigorous scientific standards for safety, effectiveness, and manufacturing quality.
The updated mRNA vaccines are approved for individuals aged 12 and older and authorized for emergency use in children aged 6 months to 11 years. As a result of these actions, the previous bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.
The FDA’s decision is backed by the evaluation of manufacturing data and non-clinical immune response data on the updated formulations, including the XBB.1.5 component. This marks a significant step in the ongoing fight against COVID-19, emphasizing the importance of staying informed and considering vaccination as a critical tool for protecting ourselves and our communities.
FDA Issues Warning Letters to Three Infant Formula Manufacturers
Today, the U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.
These warning letters for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations were issued to ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC. They reflect findings from FDA inspections of these facilities over the last several months. At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace.
Importantly, the FDA does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time. The agency is not aware of any distributed product where contamination was confirmed and believes that the recalls were effective in removing the potentially contaminated batches of product from the market. Additionally, these warning letters are not associated with any current recalls and therefore the FDA does not anticipate any impact to the availability of infant formula on the market.
The FDA is issuing these letters now as part of its normal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate corrective actions when they detect pathogens to ensure compliance with the FDA’s laws and regulations. As part of this, the firms must, among other things, thoroughly conduct root cause investigations and perform subsequent cleaning and sanitation activities. Notably, firms also need to properly evaluate their cleaning and sanitation practices, schedules, and procedures before releasing product. Each company will have 15 working days to respond to the FDA to explain what corrective actions they are taking. The FDA will assess the adequacy of the companies’ corrective actions in the agency’s review of the responses and during the FDA’s next inspection of each facility. During these inspections the agency will verify proper implementation of appropriate corrective actions taken by each company.
“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns. The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition. “Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious.”
Today’s actions are the latest in the FDA’s ongoing effort to strengthen the safety and resiliency of the infant formula supply in the U.S. In November 2022, the agency released an outline of a prevention strategy to prevent Cronobacter sakazakii illnesses associated with consumption of powdered infant formula. As part of that strategy, the FDA has been working with Congress to strengthen our regulatory tools and increase funding to oversee the infant formula industry and has worked closely with the U.S. Center for Disease Control and Prevention (CDC) to support the Council of State and Territorial Epidemiologists decision to add invasive Cronobacter infections among infants under one year of age to the Nationally Notifiable Conditions List. The agency has already started to hire staff as part of our work to establish a dedicated cadre of infant formula investigators and an Office of Critical Foods, both of which will strengthen the regulatory oversight of infant formula.
Healthy supply of infant formula available in the U.S. market
Consumers should know that the U.S. infant formula supply is healthy with in-stock rates at 85% or higher since the beginning of 2023. The current strength of this market can be largely attributed to the many actions taken by the FDA and other U.S. government partners through 2022 and 2023, which are outlined in the FDA’s National Strategy to Increase the Resiliency of the Infant Formula Market.
Ensuring the safety of powdered infant formula at home
Parents and caregivers should follow manufacturer instructions for preparing powdered infant formula. For babies less than 2 months old, born prematurely, or with weakened immune systems the CDC recommends, if possible, using ready-to-feed liquid infant formula. Liquid infant formula is made to be sterile (without germs) and is the safest option for infants not receiving breast milk. However, parents and caregivers can also take extra steps to prepare powdered formula for these infant groups by heating water to at least 158°F/70°C to help protect against Cronobacter, adding the powdered infant formula and mixing, and then cooling the formula to body temperature (98.6°F) before feeding.
However, certain metabolic and specialty products include statements on their packaging warning consumers against heating because heating that particular product above 100°F could result in a loss of vitamins and nutrients. Therefore, caregivers should be especially mindful of the manufacturer’s instructions included on the packaging for metabolic and specialty formulas.
The FDA will continue its regulatory oversight and engagement with industry to enhance infant formula safety, including continuing to conduct annual inspections of infant formula facilities, maintaining a dialogue with infant formula manufacturers on these issues, and furthering prevention-based research and activities.
In addition to around-the-clock regulatory work, the FDA remains steadfast in upholding the commitment to unify and strengthen the FDA Human Foods Program. This new vision comes as a result of the agency’s review of findings and recommendations from an external evaluation conducted by the Reagan-Udall Foundation, at the request of the FDA Commissioner, following the agency’s infant formula supply chain response.
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