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Granuflo Under a Class One FDA Recall

Granuflo FDA Recall As of June 2012, following a formal investigation, the drug Granuflo is under a Class 1 recall designated by the Food and Drug Administration (FDA) A Class 1 recall is the most serious action that the FDA can take against a potentially harmful product and is only given if the product in question can cause significant harm or death to the people who use it.

Granuflo was created by Fresenius Medical Care Inc. as an additive to traditional dialysis treatments. Both Granuflo and its sister product, NaturaLyte, were designed to help lower the acidity in dialysis patients’ blood. However, both medications have been linked to a series of unwanted and dangerous side effects.

Patients using Granuflo were found to have elevated levels of acetone in their blood. Acetone in high amounts can in turn lead to an elevated level of bicarbonate. Having too much bicarbonate can result in poor heart functions which can cause harmful effects. Notable reported Granuflo side effects include heart attacks, cardiac arrhythmia, low blood pressure, and even death in extreme cases.NaturaLyte has also been linked to side effects such as these. Fresenius denied any knowledge of the existence of these side effects when the drugs were released.

In 2012, before the FDA investigation, an internal memo from Fresenius was leaked. The information in the memo seemingly contradicted everything that Fresenius had state previously, as it warned Fresenius doctors to adjust dosage of Granuflo and NaturaLyte to avoid Granuflo heart attacks. This was a sing to many (especially those involved in the Granuflo and NaturaLyte dialysis lawsuit) that Fresenius had been aware of these side effects months, even years before they informed the public. The plaintiffs claim that had this information been released to everybody, not just Fresenius employees, lives would have undoubtedly been save.

Omontys Lawsuit Stems From Deaths and Other Omontsys Side Effects

Omontys, an anemia drug manufacturer by Affymax and Tadeka Pharmaceuticals, is intended for use specifically in the treatment of anemia caused by chronic kidney disease. Within months of approval, adverse events including severe allergic reactions, possible anaphylactic shock and death potentially associated with Omontys were being reported to the FDA. Affymax and Tadeka Pharmaceuticals have issued a voluntarily recall of all lots of the medication.

Omontys, according to the FDA approval and to the manufacturer’s website, is not intended for use in the treatment of anemia that is not related to chronic kidney disease (CDK) nor is it to be used in emergent situations that require correction of anemia by transfusion. Anemia can be caused by a variety of medical conditions including internal bleeding however better treatment options with fewer potential side effects are available for use.

The kidneys, when in a healthy state perform several functions. The two small glands located in the posterior portion of the upper abdomen, filter toxins from the blood, maintain acid-base balance and produce erythropoietin (EPO). Erythropoietin is a hormone that stimulates bone marrow to produce red blood cells. If kidney disease is severe enough to require hemodialysis, anemia already present due to CDK can be exacerbated by blood loss during dialysis.

An overview published by the National Institutes of Health explains the impact chronic kidney disease can have “Anemia is common in people with kidney disease. Healthy kidneys produce a hormone called erythropoietin, or EPO, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Diseased kidneys, however, often don’t make enough EPO. As a result, the bone marrow makes fewer red blood cells. Other common causes of anemia include blood loss from hemodialysis and low levels of iron and folic acid. These nutrients from food help young red blood cells make hemoglobin, their main oxygen-carrying protein.”

Anemia caused by any reason can be a serious health concern. Without the availability of an adequate number of red blood cells circulating in the blood, oxygen can’t be properly distributed to vital organs. As the body’s primary oxygen delivery system (red blood cells) becomes unable to deliver adequate oxygen to organs, the heart and lungs work harder to compensate. The lungs try to intake a greater load of oxygen by increasing respiratory rate and the heart beast faster in an attempt to move a diminishing supply of oxygen more quickly. If there is less of it, the body must replenish the supply more quickly.

What are the symptoms of anemia? Mild cases of anemia may be asymptomatic but as the condition worsens, symptoms will appear with the most common complaint being a tired feeling. Anemia caused by chronic kidney disease produces the same symptoms as anemia brought on by any other reason. In general, symptoms of anemia include fatigue, pale skin, shortness of breath, rapid heartbeat and chest pain. Anyone experiencing symptoms of anemia should seek medical attention as anemia is often a symptom of another potentially serious, underlying cause.

The Food and Drug Administration issued a news release announcing the approval of Omontys on March 27, 2012. According to the news release “The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD). Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.”

Omontys is an erythropoiesis-stimulating agent and is the first to be released to the market since 2001. Erythropoiesis-stimulating agents have been called a breakthrough for patients suffering from anemia related to chronic kidney disease, specific malignancies and treatment with chemotherapy. Currently, Omontys’ approval is limited to use in the treatment of anemia only for those patients suffering from chronic kidney disease and on dialysis. The FDA when approving Omontys laced the following limitations on use of the drug “Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.”

At the time of approval the FDA listed the most common Omontys side effects in their news release. “The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia)” said the FDA’s news release of March 27, 2012. In less than a year, FDA statements took on a much different hue. On February 23, 2013, the Food and Drug Administration issued a safety statement and news of a recall. The FDA’s “Firm Press Release” says

FOR IMMEDIATE RELEASE - February 23, 2013 - and OSAKA, Japan, February 24, 2013 – (BUSINESS WIRE) – Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited (Takeda) today have decided to voluntarily recall all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. The companies have been working actively with the U.S. Food and Drug Administration (FDA) which has indicated its agreement with this decision. The companies have also issued a letter to health care professionals indicating that no new or existing patients should receive OMONTYS.

What is the true emphasis of the Omontys recall? Most people will look at this and think only about the health consequence but the fact is, this is business. Kidney dialysis is a multi-billion dollar business. It has generated profits for countless manufacturers and treatment facilities. Dialysis is not only a growing health concern in the US and worldwide, it is a booming business.

Let’s get some better perspective on the massive financial implications. Production and sales of Erythropoiesis-stimulating agents is a single market within a much larger space. If Affymax and Tadeka Pharmaceuticals are not able to keep this potentially deadly drug on the market, they could take a serious financial hit. Right now they are the new kid on the block scoring a good portion of what is estimated to be over a $7 billion dollar business. Already, reports of a drop in sales and a sharp fall in stock prices have hit me news. It will be interesting to see how this unfolds. With the reported numbers of adverse events and deaths potentially linked to Omontys, it is very likely the manufacturer may need to prepare for a relatively equal number of Omontys lawsuit cases.