Omontys Recall News 3/26/13

March 26 , 2013: Omontys Recall – Background

 

Almost a year ago, Omontys was approved by the FDA.

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).

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htm

 

What is anemia? From the NIH:

 

Anemia is a condition in which your blood has a lower than normal number of red blood cells.

 

Anemia also can occur if your red blood cells don’t contain enough hemoglobin (HEE-muh-glow-bin). Hemoglobin is an iron-rich protein that gives blood its red color. This protein helps red blood cells carry oxygen from the lungs to the rest of the body.

If you have anemia, your body doesn’t get enough oxygen-rich blood. As a result, you may feel tired or weak. You also may have other symptoms, such as shortness of breath, dizziness, or headaches.

Severe or long-lasting anemia can damage your heart, brain, and other organs in your body. Very severe anemia may even cause death.

Overview

Blood is made up of many parts, including red blood cells, white blood cells, platelets (PLATE-lets), and plasma (the fluid portion of blood).

 

Red blood cells are disc-shaped and look like doughnuts without holes in the center. They carry oxygen and remove carbon dioxide (a waste product) from your body. These cells are made in the bone marrow—a sponge-like tissue inside the bones.

 

White blood cells and platelets (PLATE-lets) also are made in the bone marrow. White blood cells help fight infection. Platelets stick together to seal small cuts or breaks on the blood vessel walls and stop bleeding. With some types of anemia, you may have low numbers of all three types of blood cells.

Anemia has three main causes: blood loss, lack of red blood cell production, or high rates of red blood cell destruction. These causes might be the result of diseases, conditions, or other factors.

http://www.nhlbi.nih.gov/health/health-topics/topics/anemia/

 

Continuing with the 2012 FDA report:

 

Continuing with the 2012 FDA report:

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 represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”

Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.

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).

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.

The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data.

 

Now fast forward to 2013, with the recall of this product. 

 Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity.

eactions, including anaphylaxis, which can be life-threatening or fatal.

 

To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting.  The rate of overall hypersensitivity reactions reported is approximately 0.2% with approximately a third of these being serious in nature including anaphylaxis requiring prompt medical intervention and in some cases hospitalization.

BACKGROUND: Omontys (peginesatide) Injection is indicated for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and is packaged in 10 mg and 20 mg Multi-dose vials:

• 10mg Multi-dose Vials – NDC 64764-610-10  Lots C18685, C18881, C19258
• 20mg Multi-dose vials – NDC 64764-620-20  Lots C18686, C18696

 

What is anaphylaxis? 

 

Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. It typically causes a number of symptoms including an itchy rash, throat swelling, and lowblood pressure. Common causes include insect bites/stings, foods, and medications.

On a pathophysiologic level, anaphylaxis is caused by the release of mediators from certain types of white blood cells triggered either by immunologic or non-immunologic mechanisms. It is diagnosed based on the presenting symptoms and signs. The primary treatment is injection of epinephrine, with other measures being complementary.

 

http://en.wikipedia.org/wiki/Anaphylaxis

 

Omontys Recall in the News

The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

Omontys (peginesatide) is a man-made form of a protein that helps your body produce red blood cells. The amount of this protein in your body may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.

Omontys is used to treat anemia (a lack of red blood cells in the body) in people with chronic kidney disease who are on dialysis.

Omontys is not for treating anemia caused by other conditions. This medicine is not for use in people who are not on dialysis.

 

Until further notice, health care providers should stop using Omontys and return the product to Takeda Pharmaceuticals.

According to the companies, serious and fatal hypersensitivity reactions have been reported in some patients receiving their first dose of Omontys, given by intravenous injection. The reactions have occurred within 30 minutes following the dose. There have been no reports of reactions following subsequent dosing, or in patients who have completed their dialysis session.

The FDA has been notified by Affymax of 19 reports of anaphylaxis from dialysis centers in the United States. Three of the anaphylaxis cases resulted in death. Other patients required prompt medical intervention and in some cases hospitalization. Some of the reports included patients who were able to be resuscitated by doctors. However, anaphylaxis is life-threatening and resuscitation efforts are not always successful.

“Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys,” said Howard Sklamberg, director, Office of Compliance, FDA’s Center for Drug Evaluation and Research. “Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

Affymax and Takeda are investigating these adverse reactions.

60 Minutes and New England Compounding Pharmacy

I’m lead counsel on the Chad Green case versus New England Compounding Pharmacy, filed and currently pending in the District Court of Mass, and our office number is 404-451-7781. You can always reach me at mark(at)markzamora.com

You can find the work my firm and I have done on that case on http://www.pacer.gov. Legal Times published the Order granting my client’s request to inspect the NECC facility in Framingham, Mass, and it’s here:

Click to access dmassnecompoundinspectorder.pdf

Unfortunately, while the 60 Minutes segment presents shocking facts, there will be more. A recent CDC report shows the bad news continues to mount for innocent victims.

Notice to Clinicians: Continued Vigilance Urged for

Fungal Infections among Patients Who Received

Contaminated Steroid Injections

The CDC continues to receive new reports of fungal infection among patients who were given injections of contaminated methylprednisolone acetate (MPA) from the New England Compounding Center (NECC) in Framingham, Mass.   Most of these recent cases have been localized spinal or paraspinal infections (e.g., epidural abscesses) in patients, although new cases of meningitis or arachnoiditis also have been reported. Because many of these new cases are among patients with minimal symptoms, CDC is re-emphasizing the recommendation for clinicians to remain vigilant for fungal infections, especially in patients with mild or even baseline symptoms, and consider evaluation with magnetic resonance imaging (MRI) if clinically warranted.

Status of Fungal Disease Outbreak
As of March 4, 2013, a total of 720 cases, which includes 48 deaths, have been reported in 20 states. Current information about the outbreak, including case counts and distribution by state, and clinician and patient guidance, is available online athttp://www.cdc.gov/hai/outbreaks/meningitis.html.

Over the past several months, there has been a marked decrease in reports of fungal meningitis, but CDC continues to receive reports of localized spinal and paraspinal infections, which include epidural abscess, phlegmon, arachnoiditis, and discitis. Additionally, some of these newly identified case-patients had initially tested negative for signs of a fungal infection (either by lumbar puncture or MRI) and have subsequently developed fungal infection, indicating a prolonged incubation period.

 After the recall of NECC steroid medications on September 26, state and local health departments identified almost 14,000 people in 23 states who were potentially exposed to the implicated MPA; of these, an estimated 11,000 individuals received spinal or paraspinal injections. Through active notification by clinics with assistance from states and CDC in early October, nearly all of these exposed persons were contacted at least once and informed of their risk for fungal infection as a result of receiving injections with contaminated medication.

Despite this and subsequent patient outreach efforts, CDC and public health partners remain concerned  about the potential for some exposed patients to have localized fungal infections that have gone unrecognized. These infections may be unrecognized because some patients have not continued to receive close clinical follow-up or because they have not recognized symptoms suggestive of a localized infection, which may be difficult to distinguish from their baseline chronic pain.

As described in CDC’s HAN update on December 20(http://emergency.cdc.gov/HAN/han00338.asp), MRI testing was done on 128 patients in Michigan, Tennessee, and North Carolina who had no previous evidence of infection and had new or worsening symptoms at or near the site of their spinal or paraspinal injection. Of these, 67 (52%) had findings suggestive of localized infection. In addition, of 109 different patients reporting persistent but baseline symptoms at or near the site of their spinal or paraspinal injection, 15 (14%) also had abnormal MRI findings suggestive of infection, and 27 (25%) had non-specific enhancement of soft tissue or other paraspinal structures. The clinical significance of these findings is unclear; however, there is a theoretical risk that failure to diagnose these infections in a timely fashion could result in poor outcomes for patients (e.g., neurologic compromise, osteomyelitis, or progression to meningitis)

Patient and Clinician Recommendations

Early in the outbreak, CDC advised clinicians to closely monitor and evaluate patients who received injections of implicated MPA. Additional guidance was provided in HAN updates issued on November 20 (http://emergency.cdc.gov/HAN/han00335.asp) and December 20 (http://emergency.cdc.gov/HAN/han00338.asp). Because of the possibility that some patients may have unrecognized, localized fungal infections, CDC is re-emphasizing the following recommendations for patients who received a spinal or paraspinal injection with implicated MPA:  

 

Patients

Patients who received an injection in or near their spine from one of the three implicated lots of MPA¹ and who have any symptoms at or near the site of their injection should seek evaluation by their medical provider for the possibility of a localized infection, such as an epidural abscess.  This includes patients who initially received steroid injections for pain and continue to have persistent baseline pain.

Clinicians

As a part of continued monitoring of patients who received an injection with implicated MPA, clinicians should consider re-evaluating patients who received a spinal or paraspinal injection with implicated MPA for signs and symptoms suggestive of infection, including any symptoms at or near the site of their injection. Because of the prolonged incubation period for these infections, this guidance pertains both to patients who have not been previously evaluated and to those who have already had a prior negative evaluation (e.g., normal cerebrospinal fluid profile, normal findings on MRI) but continue to have complaints:

–          In patients with new or worsening symptoms at or near the site of their injection, clinicians should obtain an MRI with contrast of the symptomatic area(s).

–          In patients with persistent but baseline symptoms, clinicians should consider obtaining an MRI with contrast of the symptomatic area(s) because the presentation of spinal or paraspinal infections can be subtle, and may be difficult to distinguish from a patient’s baseline chronic pain.

–          In some cases, radiologic evidence of abscess or phlegmon has become apparent on repeat MRI studies performed subsequent to an initially normal imaging procedure. Clinicians should therefore have a low threshold for repeat MRI studies in patients who continue to have symptoms localizing to the site of injection, even after a normal study. However, the optimal duration between MRI studies is unknown.

–          Clinicians should also consider reviewing MRI results with a neuroradiologist because of potential difficulties in interpreting imaging results for these patients.

Revised Clinical Guidance and Clinician Information Call

In response to input from expert consultants on fungal disease and physicians who have been treating patients affected by this outbreak, CDC has revised its Interim Treatment and Diagnostic Guidance for Central Nervous System and Parameningeal Infections Associated with Injection of Contaminated Steroid Products(http://www.cdc.gov/hai/outbreaks/clinicians/guidance_cns.html). The revisions include addition of new information on several topics, including:

–          Surgical management of parameningeal disease

–          Duration of antifungal treatment

–          Monitoring clinical status after cessation of antifungal treatment

–          Information on non-first-line medications (e.g., posaconazole or itraconazole)