GESTIÓN EN SALUD PÚBLICA: Safety Alerts and Consumer Advisories

martes, 5 de diciembre de 2017

Safety Alerts and Consumer Advisories

Public Health Alert

Recent Food and Beverage Alerts Advisories and Safety

FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel

December 5, 2017

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What’s New
December 4, 2017
The U.S. Food and Drug Administration has recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.
The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.

Fast Facts

The FDA continues to investigate a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form currently marketed to “manage the metabolic processes associated with osteoarthritis.”
On November 30, 2017, the FDA reiterated to Primus Pharmaceuticals the agency’s safety concerns and serious health risks associated with continued use of the product. The FDA recommended a voluntary recall but so far the company has declined to take the product off the market.
In early September, the FDA began investigating a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form that has been marketed as a medical food to “manage the metabolic processes associated with osteoarthritis.”
As of November 21, 2017, the FDA has received a total of 194 adverse event reports regarding Limbrel. In 30 of those cases, there was sufficient information for FDA medical experts to determine whether Limbrel was likely associated with these adverse events. Since issuing its initial public advisory on November 21, the agency has and continues to receive additional reports, which it is currently evaluating.
The FDA is advising consumers not to use Limbrel because of the risk of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. If you are taking this product, discontinue it immediately and contact your health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.
Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort. If you experience any of these symptoms, contact your health care provider immediately.
Symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. If you experience any of these symptoms, contact your health care provider immediately.

What is the Problem and What is Being Done About It?

The FDA is investigating a rise in reports of serious adverse events involving Limbrel. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel; 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.

On November 8, 2017, the FDA first contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. The FDA also obtained product samples from the company and the samples are undergoing testing.

The FDA continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.

What are the Symptoms of Drug Induced Liver Injury and Hypersensitivity Pneumonitis?

The symptoms of drug-induced liver injury may vary. Common symptoms include jaundice, nausea, fatigue, and gastrointestinal discomfort.

Symptoms of hypersensitivity pneumonitis may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue.

Who is at Risk?

Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis. If you are taking Limbrel, immediately stop taking the product and contact your health care provider.

What Specific Products are in Question?

Limbrel is available in capsule form in two dosages: Limbrel250 and Limbrel500. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc. Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis.

What Do Consumers Need To Do?

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 the MedWatch Safety Information and Adverse Event Reporting Program.

What Do Health Care Providers Need To Do?

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 the MedWatch Safety Information and Adverse Event Reporting Program.

Who Should be Contacted?

Consumers and health care professionals who have questions about Limbrel are encouraged to contact the FDA’s Division of Drug Information at 888-INFO-FDA (888-463-6332) or druginfo@fda.hhs.gov.

The information in this release reflects the FDA’s best efforts to communicate what it has learned from the manufacturer and the state and local public health agencies involved in the investigation. The agency will update this page as more information becomes available.