Buprenorphine FDA Alerts
The FDA Alerts below may be specifically about buprenorphine or relate to a group or class of drugs which include buprenorphine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for buprenorphine
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
July 31, 2025 -- The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their long-term use. These changes follow a public advisory committee meeting in May that reviewed data showing serious risks—such as misuse, addiction, and both fatal and non-fatal overdoses—for patients who use opioids over long periods.
“The death of almost one million Americans during the opioid epidemic has been one of the cardinal failures of the public health establishment,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This long-overdue labeling change is only part of what needs to be done — we also need to modernize our approval processes and post-market monitoring so that nothing like this ever happens again.”
Tragically, the new drug application for OxyContin was initially approved without study data supporting its long term use to treat pain in many patient populations for which it has been prescribed. The updated labeling change reflects robust data from two large FDA-required observational studies, called postmarketing requirements (PMR) 3033-1 and 3033-2, which recently provided new data on how long-term opioid use can lead to serious side effects. After reviewing those results, public comments, medical research and recognizing the absence of adequate and well-controlled studies on long-term opioid effectiveness, the FDA decided to require safety labeling changes to help health care professionals and patients make treatment decisions rooted in the latest evidence.
“I know firsthand how devastating addiction is—not just for individuals, but for entire families and communities,” said HHS Secretary Robert F. Kennedy, Jr. “Today’s FDA action is a long-overdue step toward restoring honesty, accountability, and transparency to a system that betrayed the American people.”
FDA has required an additional prospective, randomized, controlled clinical trial to directly examine the benefits and risks of long-term opioid use. The Agency will be closely monitoring the progress of this clinical trial to ensure its timely completion.
The labeling changes will include the following updates:
- Clearer Risk Information: A summary of study results showing the estimated risks of addiction, misuse, and overdose during long-term use.
- Dosing Warnings: Stronger warnings that higher doses come with greater risks, and that those risks remain over time.
- Clarified Use Limits: Removing language which could be misinterpreted to support using opioid pain medications over indefinitely long duration
- Treatment Guidance: Labels will reinforce that long-acting or extended-release opioids should only be considered when other treatments, including shorter-acting opioids, are inadequate.
- Safe Discontinuation: A reminder not to stop opioids suddenly in patients who may be physically dependent, as it can cause serious harm.
- Overdose Reversal Agents: Additional information on medicines that can reverse an opioid overdose.
- Drug Interactions: Enhanced warning about combining opioids with other drugs that slow down the nervous system—now including gabapentinoids.
- More Risks with Overdose: New information about toxic leukoencephalopathy—a serious brain condition that may occur after an overdose.
- Digestive Health: Updates about opioid-related problems with the esophagus.
The FDA sent letters to the relevant applicants outlining the required changes. The companies will have 30 days to submit their labeling updates to the FDA for review.
More information is available in the FDA’s Drug Safety Communication.
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, radiation-emitting electronic products, and for regulating tobacco products.
Source: FDA
Hospira Inc. Issues Voluntary Recall for Buprenorphine HCl Injection Carpuject Units and Labetalol HCl Injection Carpuject Units Due to Potential for Incomplete Crimp Seals
May 21, 2024 - NEW YORK, NY., Hospira, Inc., a Pfizer company (“Pfizer”), is voluntarily recalling the lots listed in the table below of Buprenorphine Hydrochloride Injection CarpujectTM Units and Labetalol Hydrochloride Injection, USP CarpujectTM Units to the User level. The recall was initiated due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit.
In the event that impacted products are administered to a patient, there is a potential for an increased risk of lack of therapeutic effect and systemic infection that may result in the need for additional medical treatment. To date, Pfizer has not received reports of any relevant adverse events associated with this issue for these lots.
Buprenorphine HCl Injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. Buprenorphine HCl Injection is a clear, sterile, injectable agonist-antagonist analgesic intended for intravenous (IV) or intramuscular (IM) administration.
Labetalol HCl Injection is indicated for control of blood pressure in severe hypertension.
The NDC, Lot Number, Expiration Date, and Configuration details for the impacted products are indicated below. The products were distributed nationwide to wholesalers/hospitals in the United States from September 2023 through April 2024.
| Product | NDC | Lot Number | Expiration Date | Concentration | Configuration/ Count |
|---|---|---|---|---|---|
| Buprenorphine Hydrochloride Injection – CIII CarpujectTM Single-dose Cartridge/Tube Unit with Luer Lock |
Carton 0409-2012-32 Cartridge 0409-2012-03 |
HJ3965 | 2024/09 | 0.3 mg base/mL | 10 cartridge units/carton |
| HJ8546 | 2024/10 | 0.3 mg base/mL | 10 cartridge units/carton | ||
| Labetalol Hydrochloride Injection, USP CarpujectTM Single-dose Cartridge Unit with Luer Lock |
Bundle 0409-2339-34 Carton/Cartridge 0409-2339-24 |
HJ7566 | 2025/05 | 20 mg/4 mL (5 mg/mL) |
10 carton/ cartridge units/bundle |
| HN8747 | 2025/09 | 20 mg/4 mL (5 mg/mL) |
10 carton/ cartridge units/bundle |
||
| HN8749 | 2025/09 | 20 mg/4 mL (5 mg/mL) |
10 carton/ cartridge units/bundle |
Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for the return of any recalled product.
Wholesalers and hospitals with an existing inventory of any of the lots which are being recalled should discontinue use, stop distribution, and quarantine the product immediately. If you have further distributed the recalled product, please notify your accounts and/or any additional locations which may have received the recalled product. Hospitals should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Sedgwick at 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 information below.
| Contact Center |
Contact Information | Area of Support |
|---|---|---|
| Pfizer Medical Information |
800-438-1985, option 3 (Mon.-Fri. 9am – 5pm ET) www.pfizermedinfo.com |
For medical questions regarding the product |
| Pfizer Drug Safety |
800-438-1985, option 1 (24 hours a day; 7 days a week) |
To report adverse events and product complaints |
Adverse reactions 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: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being executed with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain
What safety concern is FDA announcing?
The U.S. Food and Drug Administration (FDA) is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder (OUD) and pain, and the benefits of these medicines clearly outweigh the risks.
Regular adherence to buprenorphine to treat OUD reduces withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat OUD. This approach, called medication-assisted treatment (MAT), is tailored to meet each patient’s needs and can help sustain recovery and prevent or reduce opioid overdose. According to the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), MAT has been shown to be effective in improving patient survival, decreasing opioid use, and allowing patients to live a self-directed life, including the ability to gain and maintain employment.
What is FDA doing?
We are requiring a new warning about the risk of dental problems be added to the prescribing information and the patient Medication Guide for all buprenorphine-containing medicines dissolved in the mouth. The prescribing and patient information will also include strategies to maintain or improve oral health while undergoing treatment with these medicines. These strategies will include recommending that prescribers refer patients to dental care services and encourage them to have regular checkups while taking these products. Patients should tell the dentist about all medicines they take, including buprenorphine.
What is buprenorphine and how can it help me?
Buprenorphine was approved in 2002 as a tablet to be administered under the tongue to treat OUD. In 2015, buprenorphine was approved as a film to be placed inside the cheek to treat pain. There are also buprenorphine products for pain and OUD delivered by other routes such as a skin patch and injection, but FDA has not identified a concern for dental health related to these other forms. Buprenorphine works by changing the way the brain and nervous system respond to pain. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making misuse of them less appealing. The benefits of buprenorphine medicines clearly outweigh the risks, particularly in the treatment of OUD.
The buprenorphine medicines that are associated with dental problems are tablets and films dissolved under the tongue or placed against the inside of the cheek. They are available as single-ingredient products and also in combination with naloxone. Buprenorphine medicines are marketed under the brand names Belbuca, Bunavail, Cassipa, Suboxone, Subutex, and Zubsolv. They are also available as generics.
What should patients and caregivers do?
Continue taking your buprenorphine medicine as prescribed; do not suddenly stop taking it without first talking to your health care professional as it could lead to serious consequences. Suddenly stopping these medicines could cause you to become sick with withdrawal symptoms because your body has become used to the buprenorphine medicine, or to relapse to opioid misuse that could result in overdose and death. For those suffering from addiction to opioids, the benefits of using buprenorphine medicines clearly outweigh the risks and should be considered in conjunction with counseling and other behavioral therapies. This comprehensive MAT approach is often one of the most effective ways to treat OUD, and can help sustain recovery and prevent or reduce opioid overdose.
Patients using buprenorphine medicines dissolved in the mouth should take extra steps to help lessen the risk of serious dental problems. After the medicine is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. You should wait at least 1 hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state.
Inform your health care professional if you have a history of tooth problems, including cavities. Schedule a dentist visit soon after starting this medicine and inform your dentist that you are taking buprenorphine, and schedule regular dental checkups while taking this medicine. Your dentist can customize a tooth decay prevention plan for you. Notify both your health care professional and your dentist immediately if you experience any problems with your teeth or gums.
What should health care professionals do?
Health care professionals should be aware the benefits of buprenorphine medicines clearly outweigh the risks and are an important tool to treat OUD. When combined with counseling and other behavioral therapies, this comprehensive MAT approach is often the most effective way for treating OUD, and can help sustain recovery and prevent or reduce opioid overdose.
Ask patients about their oral health history prior to prescribing treatment with a transmucosal buprenorphine medicine. These serious dental problems have been reported even in patients with no history of dental issues, so refer them to a dentist as soon as possible after starting transmucosal buprenorphine. Counsel patients about the potential for dental problems and the importance of taking extra steps after the medicine has completely dissolved, including to gently rinse their teeth and gums with water and then swallow. Patients should be advised to wait at least 1 hour before brushing their teeth. Dentists treating someone taking a transmucosal buprenorphine product should perform a baseline dental evaluation and caries risk assessment, establish a dental caries preventive plan, and encourage regular dental checkups.
What did FDA find?
Since buprenorphine was approved, we identified 305 cases of dental problems (131 cases classified as serious) with buprenorphine medicines dissolved in the mouth. These only include cases reported to FDA* or published in the medical literature,1,2 so there may be additional cases about which we are unaware. The average age of the patients was 42 years, but those as young as 18 years were also affected. Most cases were in patients using the medicines for OUD; however, 28 cases of dental problems occurred in patients using it to treat pain. In 26 cases, patients had no prior history of dental problems. Some cases reported dental problems occurring as soon as 2 weeks after treatment began, with the median time to diagnosis being approximately 2 years after starting treatment. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events. Of the 305 cases, 113 mentioned two or more teeth were affected. The most common treatment for these dental problems was tooth extraction/removal, which was reported in 71 cases. Other cases reported requiring root canals, dental surgery, and other procedures such as crowns and implants.
*The cases were reported to the FDA Adverse Event Reporting System (FAERS) database.
What is my risk?
All medicines have side effects even when used correctly as prescribed, but in general the benefits of taking a medicine outweigh the risks. It is important to know that people respond differently to all medicines depending on their health, other medicines they are taking, the diseases they have, genetic factors, and many other reasons. As a result, we cannot determine how likely it is that someone will experience these side effects when taking buprenorphine medicines that dissolve in the mouth. However, the benefits of buprenorphine medicines for OUD and pain management clearly outweigh the risks. In particular, the comprehensive MAT approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat OUD, and can help sustain recovery and prevent or reduce opioid overdose.
How do I report side effects from buprenorphine?
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving buprenorphine or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
How can I get new safety information on medicines I’m prescribing or taking?
Facts about buprenorphine
- Buprenorphine-containing medicines that are dissolved in the mouth are approved to treat opioid use disorder (OUD), and one product is approved to treat pain. These medicines are available as tablets and films to be placed under the tongue or on the inside of the cheek and kept there until completely dissolved.
- These medicines are available as single-ingredient products and in combination with naloxone. Buprenorphine medicines are marketed under the brand names Belbuca, Bunavail, Cassipa, Suboxone, Subutex, and Zubsolv. They are also available as generics.
- Buprenorphine is an opioid and works by changing the way the brain and nervous system respond to pain.
- In patients taking buprenorphine for OUD, it reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid use less appealing. When combined with counseling and other behavioral therapies, this comprehensive medication-assisted treatment (MAT) approach is often the most effective way for treating OUD. It can help sustain recovery and prevent or reduce opioid overdose.
- Common side effects of buprenorphine include headache, nausea, vomiting, constipation, pain, increased sweating, and insomnia.
- The use of buprenorphine-containing medicines that are dissolved in the mouth has been growing. The estimated number of prescriptions dispensed from U.S. outpatient retail and mail-order pharmacies increased from 11 million in 2014 to 16 million in 2020.3
Additional Information for Patients and Caregivers
- FDA is warning that dental problems such as tooth decay, cavities, oral infections, and loss of teeth have been reported with buprenorphine medicines that are dissolved in the mouth to treat opioid use disorder (OUD) or pain. These problems, some of which have been serious, have been reported even in patients with no history of dental issues. Despite this, the benefits of buprenorphine medicines clearly outweigh the risks.
- Buprenorphine medicines are an important tool to treat OUD. When combined with counseling and other behavioral therapies, this comprehensive approach is often the most effective way for treating OUD. It can help sustain recovery and prevent or reduce opioid overdose. For help finding opioid treatment centers nearest to you, visit the U.S. Department of Health and Human Services Treatment for Opioid Use Disorder and Addiction webpage or FindTreatment.gov.
- Additional information about MAT can be found on the following web pages: FDA: Information about Medication-Assisted Treatment (MAT) and SAMHSA: Medication-Assisted Treatment (MAT).
- Schedule an appointment with your dentist soon after starting this medicine and inform your dentist that you are taking it. Your dentist can customize a tooth decay prevention plan for you. Visit the dentist for regular checkups while taking this medicine.
- Notify your health care professionals immediately and seek dental treatment if you experience any problems with your teeth or gums while taking buprenorphine medicines that are dissolved in the mouth. If you are starting this medicine, tell your health care professional if you have any tooth problems, including a history of cavities.
- When taking your buprenorphine medicine and after it is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. Wait at least 1 hour before brushing your teeth.
- Do not suddenly stop taking your buprenorphine medicine without first talking to your health care professional as it could lead to serious consequences, including relapse to opioid misuse or abuse that could result in overdose and death. You could also become sick with withdrawal symptoms because your body has become used to the buprenorphine medicine.
- Read the patient Medication Guide every time you receive a prescription for buprenorphine. The Medication Guide will be updated with this new or other important information. It explains the important things that you need to know. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine.
- Talk to your health care professional if you have any questions or concerns.
- To help FDA track safety issues with medicines, report side effects from buprenorphine or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.
- You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you.
Additional Information for Health Care Professionals
- FDA is warning that cases of dental adverse events, some severe, have been reported following the use of transmucosal buprenorphine-containing medicines. Reported events include cavities/tooth decay, including rampant caries; dental abscesses/infection; tooth erosion; fillings falling out; and, in some cases, total tooth loss. Multiple cases were reported in patients with no prior history of dental problems. The most common treatment for the dental adverse events was tooth extraction/removal.
- The benefits of buprenorphine medicines clearly outweigh the risks.
- Buprenorphine medicines are an important tool to treat opioid use disorder (OUD). When combined with counseling and other behavioral therapies, this comprehensive approach is often one of the most effective ways of treating OUD. It can help sustain recovery and prevent or reduce opioid overdose. Refer patients to find opioid treatment centers by visiting the U.S. Department of Health and Human Services Treatment for Opioid Use Disorder and Addiction webpage or FindTreatment.gov.
- Additional information about MAT can be found on the following web pages: FDA: Information about Medication-Assisted Treatment (MAT) and SAMHSA: Medication-Assisted Treatment (MAT).
- Counsel OUD patients they should use their buprenorphine only as prescribed and should not stop it because they can experience serious consequences, including relapse, misuse or abuse of other opioids, overdose, and death.
- Screen patients for oral disease and ask about their oral health history prior to beginning therapy with a transmucosal buprenorphine medicine.
- Counsel patients that severe and extensive tooth decay, tooth loss, and tooth fracture have been reported with the use of this medicine and it is important to visit their dentist to closely monitor their teeth.
- Refer patients to a dentist as soon as possible after starting transmucosal buprenorphine for a baseline dental evaluation, dental caries risk assessment and preventive plan, and encourage them to have regular dental checkups while taking the medicine.
- Educate patients on strategies to maintain or improve oral health while being treated with transmucosal buprenorphine medicines. Counsel them that after the medicine has completely dissolved in the oral mucosa, to gently rinse their teeth and gums with water and then swallow. Patients should wait at least 1 hour before brushing their teeth after using the medicine, which will allow the mouth to gradually return to oral homeostasis and avoid any mechanical damage that may occur due to brushing.
- Encourage patients to read the Medication Guide they receive with each prescription, which explains the safety risks and provides other important information.
- To help FDA track safety issues with medicines, report adverse events involving transmucosal buprenorphine or other medicines to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of this page.
- You can sign up for email alerts about Drug Safety Communications on medicines or medical specialties of interest to you.
Data Summary
A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature1,2 through December 31, 2018, identified 305 cases of dental adverse events reported with transmucosal buprenorphine use. Patients with opioid use disorder (OUD) may have a higher incidence of poor dental health;4 however, many cases described severe dental issues in patients with no reported prior history of dental problems (n=26). In addition, although most of the cases were in patients using transmucosal buprenorphine products for OUD, there was a subset of patients (n=28) who experienced severe dental adverse events while receiving pain-only indicated products (e.g., Belbuca) or stated the indication was for pain.
The average age of the patients in this case series was 41.8 years (range 18-71), and the median time to diagnosis was 24.25 months (range 0.5-182). Many cases reported a combination of dental decay, tooth loss, and tooth fractures in numerous teeth. Many cases were reported by health care professionals and provided documentation of extensive dental adverse events including “all upper,” “all lower,” “all,” “majority,” “most,” “multiple teeth,” and “rampant decay.” The cases often noted the number of teeth involved, with 113 cases mentioning two or more teeth. Some cases specifically mentioned involvement of 11 to 12 or more teeth, as well as all teeth in 11 cases. Of the 305 cases, 151 reported the treatment for the adverse event, with tooth extraction/removal as the most common, which was reported in 71 cases. Other treatments included root canal, dental surgery, and other restorative procedures such as crowns and implants.
References
- Suzuki J, Park EM. Buprenorphine/naloxone and dental caries: a case report. Am J Addict 2012;21:494-5.
- Suzuki J, Mittal L, Woo SB. Sublingual buprenorphine and dental problems: a case series. Prim Care Companion CNS Disord 2013;15:PCC.13l01533.
- Symphony Health Metys™. Data 2010-2020. Data extracted May 2021.
- Yazdanian M, Armoon B, Noroozi A, Mohammadi R, Bayat AH, Ahounbar E, et al. Dental caries and periodontal disease among people who use drugs: a systematic review and meta-analysis. BMC Oral Health 2020;20:44.
Contact FDA
For More Info
855-543-DRUG (3784) and press 4
Source: FDA
Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing
ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.
BACKGROUND: Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.
The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.
RECOMMENDATION:
Patients:
- Talk to your health care professionals about the benefits of naloxone and how to obtain it.
- Recognize the signs and symptoms of a possible opioid overdose. These include slowed, shallow, or difficult breathing, severe sleepiness, or not being able to respond or wake up. If you know or think someone is overdosing, give the person naloxone if you have access to it, and always call 911 or go to an emergency room right away. Naloxone is a temporary treatment, so repeat doses may be required. Even if you give naloxone, you still need to get emergency medical help right away.
- If you have naloxone, make sure to tell your caregivers, household members, and other close contacts that you have it, where it is stored, and how to properly use it in the event of an overdose. When using opioid medicines away from home, carry naloxone with you and let those you are with know you have it, where it is, and how to use it. Read the Patient Information leaflet or other educational material and Instructions for Use that comes with your naloxone because it explains important information, including how to use the medicine.
Health Care Professionals:
- Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.
- Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose.
- Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.
- Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.
- Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.
Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178
[07/23/2020 - Drug Safety Communication - FDA]
Source: FDA
Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
ISSUE: Based on additional review, FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce these risks. FDA is requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment (MAT) drugs and benzodiazepines together.
BACKGROUND: Many patients with opioid dependence may also use benzodiazepines or other CNS depressants, either under a health care professional’s direction or illicitly. Although there are serious risks with combining these medicines, excluding patients from MAT or discharging patients from treatment because of use of benzodiazepines or CNS depressants is not likely to stop them from using these drugs together. Instead, the combined use may continue outside the treatment setting, which could result in more severe outcomes.
RECOMMENDATIONS: Health care professionals should take several actions and precautions and develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants. These include:
- Educating patients about the serious risks of combined use, including overdose and death, that can occur with CNS depressants even when used as prescribed, as well as when used illicitly.
- Developing strategies to manage the use of prescribed or illicit benzodiazepines or other CNS depressants when starting MAT.
- Tapering the benzodiazepine or CNS depressant to discontinuation if possible.
- Verifying the diagnosis if a patient is receiving prescribed benzodiazepines or other CNS depressants for anxiety or insomnia, and considering other treatment options for these conditions.
- Recognizing that patients may require MAT medications indefinitely and their use should continue for as long as patients are benefiting and their use contributes to the intended treatment goals.
- Coordinating care to ensure other prescribers are aware of the patient’s buprenorphine or methadone treatment.
- Monitoring for illicit drug use, including urine or blood screening.
Patients taking MAT drugs should continue to take these medicines as prescribed. Do not stop taking other prescribed medicines without first talking to your health care professional. Before starting any new medicines, tell your health care professional that you are taking MAT. Do not take non-prescribed benzodiazepines or other sedatives (See Table 2 in the Drug Safety Communication, List of Benzodiazepines and Other CNS Depressants) or use alcohol when taking MAT because the combined use increases the possibility of harm, including overdose and death.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[09/20/2017 - Drug Safety Communication - FDA]
Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
[Posted 05/30/2013]
ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.
The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.
BACKGROUND: To date, Lowlite has received no reports of injury or illness associated with the use of the affected products.
RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Lowlite by phone at 888-323-7788 or 407-673-2222 from the hours of 9:00AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: Brian@olympiapharmacy.com. Patients who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/30/2013 - Press Release - Olympia Pharmacy]
[05/30/2013 - Recalled Product List - Olympia Pharmacy]