FDA WARNINGS/RECALLS

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RX NEWS

 

Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication – FDA Warns About New Impulse-control Problems

AUDIENCE: Psychiatry, Internal Medicine, Patient

ISSUE: FDA is warning that compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex have been reported with the use of the antipsychotic drug aripiprazole (Abilify, Abilify Maintena, Aristada, and generics). These uncontrollable urges were reported to have stopped when the medicine was discontinued or the dose was reduced. These impulse-control problems are rare, but they may result in harm to the patient and others if not recognized. 

Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk FDA identified. In addition, FDA has become aware of other compulsive behaviors associated with aripiprazole, such as compulsive eating, shopping, and sexual actions. These compulsive behaviors can affect anyone who is taking the medicine. As a result, FDA is adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products.

See the FDA Drug Safety Communication for additional information, including a Data Summary. 

BACKGROUND: Aripiprazole is used to treat certain mental disorders, including schizophrenia, bipolar disorder, Tourette’s disorder, and irritability associated with autistic disorder. It may also be used in combination with antidepressants to treat depression.  Aripiprazole can decrease hallucinations and other psychotic symptoms such as disorganized thinking. It can stabilize mood, improve depression, and decrease the tics of Tourette’s disorder. 

RECOMMENDATION: Health care professionals should make patients and caregivers aware of the risk of these uncontrollable urges when prescribing aripiprazole, and specifically ask patients about any new or increasing urges while they are being treated with aripiprazole. Closely monitor for new or worsening uncontrollable urges in patients at higher risk for impulse-control problems.  These include those with a personal or family history of obsessive-compulsive disorder, impulse-control disorder, bipolar disorder, impulsive personality, alcoholism, drug abuse, or other addictive behaviors.  Consider reducing the dose or stopping the medicine if such urges develop.

Patients and caregivers should be alert for uncontrollable and excessive urges and behaviors while taking aripiprazole. It is important to talk with a health care professional as soon as possible if you or a family member experiences any of these uncontrollable urges, in order to prevent or limit possible harm.  Patients should not suddenly stop taking their aripiprazole medicine without first talking to their health care professional.

See the FDA Drug Safety Communication for additional information for patients, caregivers, and health care professionals.

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:

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498823.htm

 


Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall – Defective Conductivity Sensors

AUDIENCE: Risk Manager, Nephrology

ISSUE: B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.

The recalled products include

  • Model numbers: 710200L, 710200K, 710200S, 710200U, 710500L, 710500K
  • Manufacturing dates: April 1, 2013 to July 3, 2013
  • Distribution dates: June 25, 2013 to October 7, 2015

BACKGROUND: The Dialog+ Hemodialysis System is a machine used in the treatment of chronic kidney disease for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid. These systems are used in hospitals, health centers, and in outpatient dialysis center settings.

RECOMMENDATION: On April 1, 2016, B. Braun Inc. sent an “Urgent Medical Device Correction” letter to affected customers asking them to:

  • Inform all other potential users about the issue
  • Identify affected units in their inventory
  • Have a qualified service technician run a pressure test using the instructions attached with the letter
  • Tag the machine and continue its use if no drop in pressure was identified
  • Contact B. Braun Inc. customer service at 1-800-848-2066 for part replacement if air leakage was identified
  • Return a “Medical Device Correction Acknowledgment” form by email to PA_QualityAssurance.BBMUS_Service@bbraun.com or by fax to 610-849-1197

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:

Read the MedWatch alert, including a link to the FDA Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm499143.htm

 


05/04/2016 07:31 PM EDT

 

The Kroger Co. (NYSE: KR) said today it is recalling Kroger Sunflower Salad Toppers, Kroger Sunflower Kernels, and Kroger Cranberry Delight Trail Mix because a supplier indicated sunflower kernels may be contaminated with Listeria monocytogenes, an organism which could result in severe illness to those individuals who may consume these products. No customer illnesses have been reported to date

 

05/04/2016 07:58 PM EDT

 

Brown & Haley of Tacoma, Washington is taking the precautionary measure of voluntarily recalling certain lots of Mountain Thins “Trail Mix” flavor that may be impacted by sunflower seeds contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women

END RPT..

Revelation 19:16 On his robe and on his thigh he has this name written: KING OF KINGS AND LORD OF LORDS. This blog is to present Up To Date Prophetic News. My prayer is that this blog will bring others to know Jesus as their Savior if they do not know him the King of Kings and Lord of Lords.

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Posted in 2016, AMERICA, FDA, Forewarned, Signs of the Times, WORLDNEWS

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