Drug Injury Watch

Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018

In Comparison, This December 2017 Regulatory Action By FDA In The US: "new class warning... for all gadolinium-based contrast agents"

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

There seems to be a consensus among the United States FDA and the United Kingdom MHRA drug safety agencies that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-based contrast agents (GBCAs) for months to years after receiving these drugs. 

Another point of agreement between those agencies is that certain linear GBCAs -- such as Magnevist, Omniscan, and OptiMARK -- result in more gadolinium retention in the body than macrocyclic GBCAs.

There is a difference, however, between FDA and MHRA in terms of the regulatory actions being taken with respect to this class of drugs, now.

On December 14, 2017 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this document, "Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents", which includes the following statement:

There is currently no evidence that gadolinium deposition in the brain has caused adverse neurological effects in patients; however, licences for gadodiamide (Omniscan) and intravenous gadopentetic acid (also known as gadopentetate dimegulumine; Magnevist) will be suspended from 1 February 2018 and these products will be recalled.

Further, this MHRA document points out that "One linear agent, gadoversetamide (OptiMARK), has been withdrawn by the Marketing Authorisation Holder and is not available in the UK."

__________________________________________________________________

Gadolinium-Containing Contrast Agents

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

In comparison, at the present time FDA is only requiring that there be certain changes made to the Prescribing Information, or drug label, of all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) in the US.  To be clear, none of these products will be recalled from the market here.

On December 19, 2017 this document was issued, "FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings".

This document is an update to the May 22, 2017 MedWatch safety alert "Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention".

From the December 2017 FDA Drug Safety Communication:

To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.

We are continuing to assess the health effects of gadolinium retention in the body and will update the public when new information becomes available....

Accordingly, we will be watching for any future recommendations from the FDA's Medical Imaging Drugs Advisory Committee about further label changes or regulatory actions for gadolinium-based contrast agents, especially Magnevist, Omniscan, and OptiMARK, here in the US.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

FDA Recommends A Recall For Limbrel "Medical Food" Product But Primus Pharmaceuticals Is Not Complying

Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

---

UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel From The Market

... "We are not shipping. We're not promoting. We're not sampling doctors," said Primus President and CEO James Weir. "We have terminated all of those activities in good faith even though we don't believe our product is life threatening."

Primus sells Limbrel as a "medical food," but the FDA said last month that the product is an unapproved drug linked to 194 adverse events over the last decade.

[Article continues at original source]

(1/5/18)

---

 

According to the "What is Limbrel?" page of the Limbrel.com website (accessed 12/8/17) which is presented by Primus Pharmaceuticals, Inc.:

Limbrel contains flavocoxid, a proprietary blend of natural ingredients from phytochemical food source materials. Flavocoxid is comprised primarily of the flavonoids such as baicalin and catechin.

From the "FDA Limbrel Alert" page of the Limbrel.com website (accessed 12/8/17):

Limbrel has not been recalled though the FDA has asked Primus to make a voluntary recall. Primus is waiting to obtain the documents on which FDA has based its safety alert and recall request prior to making a final decision, although the opinions of independent experts and the medical literature conflict with FDA’s safety alert and request for recall.

We first reported about the November 21, 2017 FDA warning about Limbrel last month in this post, "Osteoarthritis 'Medical Food' Limbrel Tied to Life-Threatening Events".

Since then there was this December 4, 2017 FDA statement:

The U.S. Food and Drug Administration 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 any Limbrel products because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking any Limbrel products 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.

__________________________________________________________________

Limbrel

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

More information about the apparent stand-off between the FDA and Primus Pharmaceuticals can be found on that same web page, "FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel", which includes these three points in the "Fast Facts" section:

• 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.
• The FDA is advising consumers not to use any Limbrel products 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.

On that same FDA page, the next section, "What is the Problem and What is Being Done About It?", provides some additional information about this unfolding Limbrel situation:

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.

We will continue to follow this developing drug safety issue. Further, we welcome anyone with insights to the Limbrel situation to post their information in a Comment below or share it with us privately by sending me an email.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)