Drug Injury Watch

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)

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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)

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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.

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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)

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Omontys-Related Adverse Reactions And Deaths Update: Are There More Cases Than Initially Disclosed

FDA Adverse Event Report For Omontys Reveals Affymax And Takeda May Have Downplayed Magnitude Of Problems

(Posted by Tom Lamb at DrugInjuryWatch.com)

When the dialysis - anemia medication Omontys was recalled in February 2013 it was reported that five patients had died due to intravenous use.  Since then, there has not been much information about these Omontys associated deaths from the responsible drug companies, Affymax and Takeda, nor the FDA.

We now have an update on the Omontys situation from a financial web site, SeekingAlpha.com, which published this article on October 15, 2013: "New Data Show Omontys At Least 4x Worse Than Reported: Now 22 Suspected Deaths".

From this SeekingAlpha article about the Omontys recall situation we get these excerpts:

• In our effort to get to the bottom of the Omontys saga, we asked the FDA to send us the Adverse Event report for Omontys, which can be found in its entirety here (107 pages long). The data shows there have been 22 deaths in which Omontys was reported to be the most likely cause of death!Furthermore, the report shows there has been at least one death (multiple additional cases of adverse events) reported as a result of subcutaneous administration of Omontys.
• We were surprised at the sheer volume of serious adverse events reported in relation to Omontys, and were reminded of something Dr. Steven Nissen said about the risks vs. benefits of Omontys at a 2011 FDA ODAC meeting: "So what I'm fearful will happen is that…you're going to be back here in front of this committee in the future, as you have been in the past, with this drug [Omontys], as you have with other drugs, with some surprises down the road."

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To bring you up to speed, if previously unfamiliar with this Omontys drug safety issue, we refer you to our two previous articles:

Fate Of Affymax Anemia Drug Omontys Remains Uncertain As FDA And Drug Company Continue To Study Cause Of Drug Reactions (4/1/13) 

Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal (2/25/13)

We will continue to monitor this relatively small-scale but serious drug safety issue concerning Omontys.

Further, we are currently working on some drug injury lawsuits involving Omontys.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

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Fate Of Affymax Anemia Drug Omontys Remains Uncertain As FDA And Drug Company Continue To Study Cause Of Drug Reactions

Fresenius Dialysis Clinics Decided To Stop Using Omontys Before FDA Warning Came Out Due To Five Adverse Event Reports From One Day In February 2013

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Omontys (peginesatide) injection had been used in more than 25,000 patients since it was approved by the FDA in March 2012 to treat kidney dialysis patients for anemia stemming from chronic kidney disease.  Omontys was generally more convenient than other anemia drugs in that it can be infused once month, while other anemia drugs generally are given a dozen or more times a month.

Less than a year after Omontys was FDA-approved, however, all lots of this apparently unsafe drug were recalled by its manufacturer, Affymax Inc., as we reported in this article, "Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal".

Now, a new Wall Street Journal (WSJ) piece by reporter Thomas M. Burton provides some interesting background  information about the Omontys safety signals that started to emerge back in August 2012 and were finally detected in February 2013.

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From this March 29, 2012 WSJ news report, "Anemia Drug Had Early Side Effects":

A total of 98 "adverse events" tied to the drug were reported to the FDA by Feb. 22 of this year, the day before the recall. There were 12 deaths among the reports to the FDA, but the cause of death wasn't specified, and the patients getting dialysis and Omontys are by definition already very sick. Takeda said there were five deaths that the companies considered in deciding to recall Omontys lots on Feb. 23....

Fresenius Medical Care AG, which operates 1,800 dialysis facilities in the U.S., said it has used Omontys in over 18,000 patients.

It said that shortly after it expanded use of the drug in February, on Feb. 11 "five adverse event reports of allergic type reactions were received," according to a company spokesman. Soon after, Fresenius decided to "pause" in its use of Omontys, the spokesman said.

We are currently investigating what appears to be one of those February 11, 2013 adverse events at a Fresenius dialysis clinic.  Our case involves a woman in Florida who suffered a life-threatening anaphylactic reaction for which she was hospitalized three days.

Generally, anaphylactic reactions, or anaphylaxis, are acute allergic reactions in which the patient's airway constricts making it a struggle to breathe, with blood pressure plummeting and the heart beating erratically such that it might not be able to pump enough blood.

According to the March 2013 WSJ article about Omontys, the FDA is currently "evaluating various factors" in its determination about whether Omontys will be sold again, or not, in the U.S.

We are actively monitoring the Omontys recall situation and investigating possible products liability lawsuits for serious side effects involving hypersensitivity reactions such as anaphylaxis, which can be fatal and result in the patient's death.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

Kidney Dialysis Anemia Drug Recall: Omontys: Hypersensitivity / Allergic Reactions And Anaphylaxis; Serious Side Effects With Some Being Fatal

Omontys: Deaths During Initial Injection Within 30 Minutes During Treatment Of Anemia Due To Chronic Kidney Disease In Hemodialysis Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Omontys (peginesatide) injection was approved in March 2012 to treat adult patients on hemodialysis with anemia stemming from chronic kidney disease. Omontys is one of the synthetic erythropoiesis-stimulating agents (ESAs). It is given by injection and packaged in 10- and 20-mg multidose vials.  Takeda Pharmaceutical Co. and Affymax Inc. are the responsible drug companies.

A February 24, 2013 New York Times article, "Anemia Drug Is Recalled After Allergic Reactions", by reporter Andrew Pollack, provides a concise yet insightful report of this new and still emerging drug safety issue:

The F.D.A. said in a news release on Sunday that it had received 19 reports of anaphylaxis, a severe allergic reaction, and that three of the patients had died, while others required prompt medical intervention or hospitalization....

Affymax and Takeda said that hypersensitivity reactions have been fatal in 0.02 percent of the roughly 25,000 patients treated with Omontys since its approval. That would suggest there have been five deaths, a slight discrepancy from the F.D.A. figures that was not explained. Over all, the companies said, about 2 of every 1,000 patients had a hypersensitivity reaction.

The companies and the F.D.A. said the reactions occurred within 30 minutes of patients receiving their first dose by intravenous administration. No problems have been reported with subsequent doses, which are given once a month. Still, the companies and the F.D.A. advised that Omontys use be discontinued even by patients who have already had more than one dose....

Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, said that unless the problem was because of contamination, “this could easily lead to withdrawal of drug approval.” He said that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen.

Here are links to some of the source material referenced above:

• Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions [February 23, 2013 FDA MedWatch Safety Information]
• Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection [February 23, 2013 Press Release from drug companies]

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This February 24, 2013 article, "Fatal Reactions Prompt Omontys Recall", published online by MedPage Today, gives some interesting background information about the FDA approval of Omontys:

The drug was approved by the FDA in March 2012 after an advisory panel had endorsed the drug by a 15-1 vote, with one member abstaining.

During that meeting, panel chair Wyndham Wilson, MD, PhD, chief of the lymphoma division at the National Cancer Institute in Bethesda, Md., said it appeared that [Omontys (peginesatide)] "doesn't have any safety signals."

Some 2,600 patients had participated in the drug's phase III trials, about half of them assigned to [Omontys (peginesatide)].

Steve Nissen, MD, of the Cleveland Clinic, cast the lone "no" vote at the advisory committee meeting. He had cited the lack of blinding in the trials as his rationale for opposing approval.

We are reviewing Omontys cases involving serious and sometimes fatal adverse hypersensitivity reactions, including anaphylaxis, as possible drug injury lawsuits against Takeda and Affymax.  Free Case Evaluation

Of course, we will be watching to see whether these reported allergic reactions and deaths will cause Omontys to be withdrawn from the market.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)