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Belbuca FDA Alerts

The FDA Alert(s) below may be specifically about Belbuca or relate to a group or class of drugs which include Belbuca (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. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for buprenorphine

Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing

Jul 23, 2020

Audience: Consumer, Health Professional, Pharmacy

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

Sep 20, 2017

Audience: Health Professional, Pain Management

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:

[09/20/2017 - Drug Safety Communication - FDA]

Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance

May 30, 2013

Audience: Consumer

 

[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:


[05/30/2013 - Press Release - Olympia Pharmacy]
[05/30/2013 - Recalled Product List - Olympia Pharmacy]

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