Recalls

Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

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[Posted 06/13/2019]

AUDIENCE: Patient, Healthcare Professional

ISSUE: The FDA is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational fecal microbiota for transplantation (FMT):

  • Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli). One of the individuals died.
    • FMT used in these two individuals were prepared from stool obtained from the same donor.
    • The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E. coli identical to the organisms isolated from the two patients.

RECOMMENDATION: Patients considering FMT to treat C. difficile infection should speak to their health care provider to understand the potential risks associated with the product’s use.

Healthcare providers must obtain adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by FMT and the resultant serious adverse reactions that may occur. 

  • Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
  • MDRO testing of donor stool and exclusion of stool that tests positive for MDRO. FDA scientists have determined the specific MDRO testing and frequency that should be implemented.

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
  • 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

[06/14/2019 – Safety Communication – FDA]

http://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due

test article-5/9-FT-Medwatch RSS Feed

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test article-5/9-FT-Medwatch RSS Feed

http://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/test-article-59-ft-medwatch-rss-feed

Certain Prescription Insomnia Medicines: New Boxed Warning – Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

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[Posted 04/30/2019]

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with

  • Lunesta (eszopiclone)
  • Sonata (zaleplon)
  • Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)

than other prescription medicines used for sleep.

BACKGROUND: Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

RECOMMENDATION: 

If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:

  • Stop taking your insomnia medicine.
  • Contact your health care professional right away if you.

Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:

  • Although rare, the behaviors caused by these medicines have led to serious injuries or death.
  • To discontinue taking these medicines if they experience an episode of complex sleep behavior.

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.fda.gov/MedWatch/report 
  • 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

[04/30/2019 – Drug Safety Communication – FDA] 

http://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused

E-cigarette: Safety Communication – Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

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[Posted 04/03/2019] 

AUDIENCE: Consumers, Emergency Medicine, Health Professionals 

ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional or accidental swallowing of e-liquid. However, a recent uptick in voluntary reports of adverse experiences with tobacco products that mentioned seizures occurring with e-cigarette use (e.g., vaping) signal a potential emerging safety issue.  

RECOMMENDATIONS:

Healthcare Professionals should:

  • Ask patients about e-cigarette use (e.g., vaping), particularly when providing care following a seizure.

  • Consider testing cotinine levels, a nicotine metabolite, in addition to the typical urine toxicology screening tests.

  • Even in e-cigarette users, proceed with the usual work-up to identify or rule out other causes of seizures.

  • Refer all users for tobacco cessation assistance.

Redacted reports of past incidents are available on the FDA website and may assist medical evaluations of seizures.

Healthcare professionals and consumers are encouraged to report adverse events, or any problems related to these products to the Safety Reporting Portal.

 [04/03/2019 – Press Announcement – FDA] 

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm635240.htm

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication – Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

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[Posted 02/25/2019]

AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology

ISSUE: FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

BACKGROUND: When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.

RECOMMENDATION:  Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating. Monitor patients for the signs and symptoms of pulmonary embolism, and advise them to seek medical attention immediately if they experience them.

Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition. Patients taking tofacitinib should seek medical attention immediately if you experience symptoms of a blood clot in your lungs or other unusual symptoms such as:

  • Sudden shortness of breath or difficulty breathing   

  • Chest pain or pain in your back

  • Coughing up blood

  • Excessive sweating

  • Clammy or bluish colored skin

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.fda.gov/MedWatch/report

  • 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

[02/25/2019 – Drug Safety Communication – FDA]







https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm

Fluoroquinolone Antibiotics: Safety Communication – Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

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[Posted 12/20/2018]

AUDIENCE: Health Professional, Infectious Disease, Cardiology, Patient

ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

RECOMMENDATION:
Healthcare professionals should:

  • Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients. 

  • Prescribe fluoroquinolones to these patients only when no other treatment options are available. 

  • Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm. 

  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should:

  • Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back. 

  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately. 

  • Inform your health professional before starting an antibiotic prescription,  if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome. 

  • Not stop the antibiotic without first talking to your health care professional.

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:

  • 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

[12/20/2018 – Drug Safety Communication – FDA]







https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm628960.htm

Gilenya (fingolimod): Drug Safety Communication – Severe Worsening of Multiple Sclerosis After Stopping the Medicine

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[Posted 11/20/2018]

AUDIENCE:
Patient, Health Professional, Neurology, Pharmacy

ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

RECOMMENDATION:

Healthcare professionals should:

  • Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.

  • Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.

  • Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.

  • Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.

  • Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.

Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

  • weakness

  • trouble using arms or legs

  • changes in thinking, eyesight or balance.

Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

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.fda.gov/MedWatch/report

  • 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

[11/20/2018 – Drug Safety Communication – FDA]







https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm

Implanted Pumps: Safety Communication – Use Caution When Selecting Pain Medicine for Intrathecal Administration

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[Posted 11/14/2018]

AUDIENCE: Patient, Caregiver, Health Professional, Pain Management, Pharmacy, Neurology, Surgery

ISSUE: The FDA is aware that patients undergoing treatment or management of pain are commonly given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump. While individual patients may experience some relief from using pain medicines not approved for intrathecal administration in their implanted pumps, such use may create additional risks including dosing errors, pump failures, and other safety concerns. The FDA wants to ensure that patients, caregivers, compounders, pharmacists, and health care providers are aware of these risks to make informed treatment decisions.

BACKGROUND: Implanted pumps are medical devices that are surgically implanted under the skin, typically in the abdomen. They are connected to an implanted catheter and are used to deliver prescription medicines and fluids within the body, including the intrathecal space (into the spinal fluid), to treat pain, muscle spasticity, and other diseases or conditions. Implanted pumps are periodically refilled with medicines or fluids by a health care provider.

They are often used to treat or manage pain after other treatments, such as oral medicines, physical therapy, or surgery, are unsuccessful.

The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses. The implanted pump’s current labeling should be reviewed to determine which pain medicines are approved for use in each pump. The table below includes examples of medicines approved and not approved for intrathecal use with implanted pumps to treat or manage pain.

RECOMMENDATION: When considering a medicine for use in an implanted pump:

  1. Review the implanted pump labeling to identify the medicines and medicine concentrations approved for use with that specific pump.

  2. Be aware that the following medicines are NOT currently approved for use with implanted pumps for intrathecal infusion of pain medications:

    • Medicines not FDA approved for intrathecal administration or intrathecal implanted pump use (for example, hydromorphone, bupivacaine, fentanyl, clonidine)

    • Any mixture of two or more different kinds of medicines

    • Any compounded medicine (for example, to achieve higher concentration or different formulation of an FDA approved medicine)

  3. Be aware that while individual patients may experience some relief from using medicines not approved for intrathecal administration in their implanted pumps for pain management, such use may pose additional risks including pump failures, dosing errors, and other potential safety issues.

  4. Health care providers, patients, and caregivers are encouraged to consider and discuss both the benefits and risks of using implanted pumps for the intrathecal infusion of medications for pain management in order to make informed treatment decisions.

  5. Report adverse events to the FDA if you suspect an implanted pump is having problems:

    • User facilities must comply with the applicable Medical Device Reporting (MDR) regulations.

    • Health care providers employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

  • 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.fda.gov/MedWatch/report

  • 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

[11/14/2018 – Medical Device Safety Communication – FDA]







https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm625862.htm

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