UD FDA Advice against Limbrel Capsules, a Medical Food, as it is Linked to Potentially Life-Threatening Health Problems

The US Food & Drug Administration (US FDA)  has issued an advisory against the consumption of Limbrel capsules as it is lined to potentially life threatening health problems. Limbrel is a medical food to manage the metabolic processes associated with osteoarthritis.

Totally, the FDA has received 194 adverse event reports regarding Limbrel; of those, 57  contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists.

The link to the Advisory is:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm

The Advisory contains the following recommendation:

RECOMMENDATION:

  • For Consumers: If you are taking Limbrel, immediately stop taking it and contact your health care provider.  If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through MedWatch.
  • For Health Professionals: Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through MedWatch.

You may read the medical details about Limbrel from the manufacturer’s note from the following link:

http://www.limbrel.com/downloads/limbrel_pi.pdf

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About ksparthasarathy

I am a former Secretary of the Atomic Energy Regulatory Board. I am a former Raja Ramanna Fellow in the Department of Atomic Energy. Free lance journalism is my hobby
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