Thursday, March 28, 2013

FDA scolds company for Facebook Liking unapproved product claim


AMARC Enterprises, a supplement maker, advertises the benefits of its product — a drug called Poly-MVA — through using supposed customer claims about it. The item isn’t approved by the FDA, so the company most likely thought this method was a clever way to advertise the product without having to present any sort of actual evidence as to its claims. This didn’t please the FDA, which sent a warning letter to AMARC, stating that since Poly-MVA isn’t FDA-approved, the customer testimonials essentially falsify the product as approved.

Here's the letter:

Amarc Enterprises 12/11/12

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax            (949) 608-4415 

SIGNATURE REQUIRED                                                           
December 11, 2012
                                                                                                                                                     WL  11-13
AMARC Enterprises, Inc.
Attn: Albert Sanchez, CEO
1339 Broadway
El Cajon, CA 92021
Dear Mr. Sanchez:
This letter concerns your firm’s marketing of the products, Poly-MVA and Poly-MVA for Pets. The U.S. Food and Drug Administration (FDA) reviewed your websites, and, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act. 
In addition, we reviewed your websites at and where you promote and sell your “Poly-MVA for Pets” veterinary product. We have determined that Poly-MVA for Pets is intended for use in the cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Act. [21 U.S.C. § 321(g)(1)]. Further, as discussed below, this product is an unapproved new animal drug as defined by the Act and your marketing of it therefore violates the law.  
Examples of claims in the form of testimonials, on your websites, and, on the webpage titled, “Customer Experiences” include:
  • “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. I began a regimen of PolyMVA…After 3 months, the Stage 2 cancer was down to Stage 1. And here I am, 3 years later…the PET Scan is as clear as a bell. Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”

  • “...I said “No” Chemotherapy!...I became quite ill and was diagnosed with stage 3 ovarian cancer…I had surgery to remove a very large tumor and was scheduled to begin an aggressive chemotherapy regimen as the cancer had spread. Even with chemotherapy I was aware that the prognosis was not encouraging…One of the supplements that my naturopath highly recommended was Poly MVA…In my opinion anyone in my situation involving cancer could be greatly improved by using Poly MVA…”
Examples of claims also appear in the information packet, which was purchased from your website,, and accompanied the shipment of your product, “Poly MVA.” Included in the packet is a book titled, “Poly-MVA A New Supplement in the Fight Against Cancer” with the following claims:
In Chapter 6 which is titled, “Palladium Lipoic Complex: Research Evidence”
On page 23:
  • “[An] [o]ncological surgeon…administered Palladium Lipoic Complex intravenously to ninety-five patients. The cancers from which these patients suffered included cancers of the breast, lung, colon rectum, prostate, pancreas, ovary, skin (malignant melanoma), and brain. Ninety percent of the patients had failed to improve after undergoing virtually all available therapy. During their experimental treatment with Palladium Lipoic Complex, they received moderate doses of chemotherapy. Under normal circumstances, 20 to 60 percent of patients would only survive an average of another six months. However, nine months after initiation of intravenous Palladium Lipoic Complex, 90 percent of them were still alive.”
In Chapter 7 titled, “True Stories of Cancer Survival with Palladium Lipoic Complex” are numerous testimonials, including the following:
On pages 32-33:
  • “[A] forty-two-year-old breast cancer survivor discovered Palladium Lipoic Complex very shortly after her breast cancer diagnosis…At the time of her surgery, she had been taking Palladium Lipoic Complex for fifteen days, and a preoperative ultrasound showed that her tumor had shrunk.”
On page 41:
  • “Today, Daniel’s tumor is inactive due to necrosis. There has been “no growth” since he began taking PdLA. The post-radiation side effects are more manageable because of this supplement.”
On Page 44 under the heading, “Case Study 4: Multiple Myeloma”:
  • “An Alaskan woman diagnosed with multiple myeloma sent a letter to the makers of Palladium Lipoic Complex. She had received her diagnosis…and after taking Palladium Lipoic Complex for a little over two years, she was told that her blood tests and exams showed “no measurable signs of multiple myeloma carcinoma” and that she was “in total remission.””
On Pages 45-46, under the heading, “MANY MORE SUCCESS STORIES”:
  • “A thirty-month outcome-based investigation by Dr. James W. Forsythe, lends further support for Palladium Lipoic Complex in the treatment of late-stage cancer…In this study, the greatest impact of Palladium Lipoic Complex was seen in cancers of the breast, lung, and prostate…As you have read, Palladium Lipoic Complex has powerful, remarkable results for many types of cancer patients.”
In Chapter 8 which is titled, “Using Palladium Lipoic Complex for Nutritional Support and Protection”
On pages 47-48:
  • “In a time when one out of three people can expect to have cancer at some point, it make sense to improve your odds every way you can and Palladium Lipoic Complex…would be an excellent way to do so.”
  • “Free-radical accumulation with inadequate antioxidant protection is implied in the causes and effects of many other diseases, including diabetes, Alzheimer’s dementia, heart disease, stroke and arthritis. Palladium Lipoic Complex is a superior antioxidant that could help to prevent these diseases as well.”
  • “When Palladium Lipoic Complex is administered immediately following a global ischemic insult, apoptic death is reduced by 70 percent.”
  • “Practitioners who use Palladium Lipoic Complex have found that both oral and topical versions are effective for the treatment of psoriasis – even the most severe cases.”
  • “Palladium Lipoic Complex offers a remarkably effective alternative treatment for endometriosis.”
On page 53 titled, “Conclusion”:
  • “PdLA compounds were specifically designed to support healthy cells with the goal of selectively destroying abnormal cells without harming noncancerous cells. The manner in which Palladium Lipoic Complex does so has yet to be completely explained, but the research and the success stories from cancer patients are compelling enough – and the substances nontoxic enough – to merit its use by anyone who wishes to reverse or prevent cancer.”
The information packet also included a document titled, “Testimonials” which contains the following claims:
  • “I would recommend Poly-MVA for anyone wanting to be more healthy…especially if your systems are compromised…due to cancer.”
  • “I received the news of my recurrent brain tumor with dread and shock. My father…sent me my first bottle of Poly-MVA. I took it immediately along with the conventional treatments. Since then, I have had clean MRI scans and I consider Poly-MVA…to be the cornerstones of my recovery.”
  • “I was diagnosed with uterine cancer (carcino sarcoma)…I had radical surgery and there was the possibility that it may have metasticized [sic] into the upper abdomen. I was introduced to this product…before I was scheduled for chemotherapy…I never had nausea or vomiting. I had increased energy and a hearty appetite. My…Gyn Oncologist…was so amazed at my rapid recovery…During cold and flu season I was not affected. My blood cells were normal…I did receive a miracle and I know that God has given you the formula for helping people with life threatening diseases…I had recovered so well and so fast that I did not need to complete the radiation and chemotherapy treatments that were supposed to last for six more months…”
We also noted the following claims on your firm’s website, that show the intended uses of Poly-MVA for Pets:
On the webpages titled, “Tumors in Cats”, “Leukemia in Cats”, “Lymphoma in Cats”, “Symptoms of Cancer in Dogs”, “Osteosarcoma in Dogs”, “Sarcomas in Dogs”, and “Cancer in Dogs”:
  • “Poly-MVA for Pets is a unique and patented nutriceutical form of nutritional support for animals, clinically shown to be effective by numerous veterinarians and pet owners alike for animals undergoing cancer therapy. The unique nature of Poly-MVA for Pets makes it safe, effective and well-suited for your pet, so your beloved companion will feel better and experience a greater quality of life.”
On the webpage titled, “About Poly-MVA for Pets”:
  • “Poly MVA for Pets is perfect for animals facing all types of health, nutrition or energy challenges. Furthermore, if your pet is dealing with a difficult illness, or an associated treatment such as chemotherapy or radiation therapy, Poly-MVA for Pets may be just what you’re looking for.”

  • “Notable with the cancer research is the fact that a majority of the most common canine cancers have seen positive results when PdLA is a part of an integrative protocol:”

  • “The largest clinical integrative cancer investigation of PdLA was a veterinary oncology program with over 900 dogs enrolled. Patients received the PdLA supplement as part of their chemotherapy radiation and/or surgical protocol. The PdLA seemed most effective in the cases of solid tumors (i.e. soft tissue sarcoma, hemangiosarcoma, mast cell, transition cell carcinoma, lung, anal sac carcinoma, renal carcinoma, squamous cell carcinoma, fibrosarcoma, melanoma, menigioma [sic],neuroblastoma, mammary adenocarcinoma). Some of the most effective findings were apparent in the osteosarcoma patients. (Notable is that the cause/origin of osteosarcoma in large dogs is considered identical to the disease progression in human children.) In this study, integrative PdLA support (PdLA + amputation) improved the animals' median survival time 62% (103 days more) compared to surgery alone. When the PdLA supplement was added to the chemotherapeutic regimen, the dogs exhibited a 27% longer median survival (79 days more).”

  • “A leading veterinary oncologist used PdLA in his practice and concluded that following PdLA complementary support, chemotherapeutic animals demonstrated improvements in various objective parameters (i.e. weight, anemia, liver and kidney function).”
On the webpage titled, “Pet Nutrition”:
  • “Whether your pet is an older pet, is facing a serious illness and/or harsh treatment. . . Poly-MVA for Pets offers nutritional support that can ensure that your animal companion maintains a full, active and enjoyable life.”
On the webpage titled, “Find a Vet”:
  • “Many veterinarians across the country are utilizing Poly-MVA for Pets in their protocols for overall pet health and well-being, and when dealing with degenerative disease.”
On the webpage titled, “Customer Experiences” you include claims in the form of testimonials which establish the intended use of your product, “Poly-MVA for Pets” as a drug. Several examples of these claims include, but are not limited to, the following:
  • “I started my chow on Poly-MVA for Pets right away, along with other nutrients, to help her immune system keep her melanoma at bay. That was years ago, and she is still full of life and still bringing joy to our lives!”
  • “My 10-year-old chocolate lab. . . was diagnosed with liver cancer. . . I was told she had a month to live. . . . the vet. . . did say “you might want to try Poly-MVA for Pets for support”. . . . now. . . [my dog] is eating again and still taking her 2.1 mile walks a day!”
We also note claims made on your Facebook account accessible at:, which includes a link to your website at The following are examples of the claims:
            In a March 10, 2011 post which was “liked” by “Poly Mva”:
  •  “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC”
In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at At the end of the post is the following statement and a link to the website,
  • “For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.”
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended uses. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Further, Poly-MVA for Pets is considered a “new animal drug” under section 201(v) of the Act [21 U.S.C. § 321(v)] because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-l]. Poly-MVA for Pets is not approved or index-listed by the FDA, and therefore the product is considered unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)] and adulterated under section 501(a)(5) of the Act. [21 U.S.C. § 351(a)(5)].   The introduction of adulterated drugs into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.

FDA and the GAO Report on Dietary Supplements

Interesting summary just released last week:

What GAO Found

From 2008 through 2011, the Department of Health and Human Services' Food and Drug Administration (FDA) received 6,307 reports of health problems--adverse event reports (AER)--for dietary supplements; 71 percent came from industry as serious adverse events as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA's product categories. However, FDA may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events. From 2008 to 2010, these centers received over 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said that they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.
To help ensure firms are complying with AER requirements (i.e., submitting serious AERs, maintaining AER records, and including firms' contact information on product labels), FDA increased its inspections of supplement firms and took some actions against noncompliant firms. Specifically, FDA increased firm inspections from 120 in 2008 to 410 from January 1 to September 30, 2012. Over this period, FDA took the following actions: 3 warning letters, 1 injunction, and 15 import refusals related to AER violations, such as not including contact information on the product label or submitting a serious AER.
FDA has used AERs for some consumer protection actions (e.g., inspections and warning letters) but may be able to expand their use. FDA officials said that most AERs do not initiate or support such actions because it is difficult to establish causality between the product and the health problem based on the limited information in an AER. However, FDA does not systematically collect information on how it uses AERs for consumer protection actions; by collecting this information, it may be able to assess whether AERs are being used to their fullest extent. In addition, FDA is not required to provide information to the public about potential safety concerns from supplement AERs as it does for drugs. Making such information public, if consistent with disclosure provisions in existing law, could expand FDA's use of AERs and improve consumer awareness and understanding of potential health events associated with dietary supplements.
FDA has partially implemented all of GAO's 2009 recommendations, such as issuing guidance for new dietary ingredients, clarifying the boundary between dietary supplements and conventional foods, and expanding partnerships to improve consumer understanding. Specifically, FDA developed draft guidance in 2009, 2011, and 2012 to address three GAO recommendations about dietary supplement oversight and formed new partnerships to conduct consumer outreach. However, FDA has not issued final guidance in two cases. FDA officials said that they plan to complete implementation, but they have provided no time frame to do so. With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA's enforcement burden in these areas.

Why GAO Did This Study

Dietary supplements, such as vitamins and botanical products, are a multibillion dollar industry; national data show that over half of all U.S. adults consume them. FDA regulates dietary supplements and generally relies on postmarket surveillance, such as monitoring AERs, to identify potential concerns. Since December 2007, firms receiving a serious AER have had to report on it to FDA within 15 days. In January 2009, GAO reported that FDA had taken several steps to implement AER requirements and had recommended actions to help FDA identify and act on safety concerns for dietary supplements. GAO was asked to examine FDA's use of AERs in overseeing dietary supplements. This report examines the (1) number of AERs FDA has received since 2008, their source, and types of products identified; (2) actions FDA has taken to ensure that firms are complying with AER requirements; (3) extent to which FDA is using AERs to initiate and support its consumer protection efforts; and (4) extent to which FDA has implemented GAO's 2009 recommendations. GAO analyzed FDA data, reviewed FDA guidance, and interviewed FDA officials.

What GAO Recommends

GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.

Rick Schulte Fights for Justice in a Preemption Case, Gets client a W

I'm lucky to count lawyer Rick Schulte as both a friend and fellow lawyer on cases involving innocent consumers.

Rick has been toiling away in pharmaceutical litigation, and he (like others) has been faced with the daunting task of addressing preemption issues in cases involving generic drugs.

As many lawyers know, in 2011, the Supreme Court ruled in PLIVA v. Mensing that consumers could not bring failure to warn lawsuits against generic drug manufacturers under state law because generic drug makers are bound by federal law to match a drugs label to its brand name equivalent. However, during the High Court trial, it was brought out that PLIVA failed to keep the generic drug metoclopromide updated with the warning label on the brand name counterpart Reglan.

Rick brought suit in the case of Eleanor Fulgenzi. She used PLIVA’s metoclopromide between 2004 and 2007 to treat her gastric reflux, while the generic drug carried the outdated warning. It was filed before the Mensing decision was handed down. 

After Mensing,an Ohio district court found that the Supreme Court ruling in PLIVA v. Mensing barred her claims against the generic drug maker. The 6th Circuit Court disagreed and reinstated the case.

Rick argued that according to the federal rule of sameness, PLIVA was obligated to update the warning label of the generic drugs as the warning label on the brand drug was updated. In its unanimous decision, the three-judge panel wrote that “not only could PLIVA have independently updated its labeling to match that of the branded manufacturer … it had a federal duty to do so,” (Fulgenzi v. PLIVA Inc, 6th U.S. Circuit Court of Appeals, No. 12-3504). 

PDF here
It's too easy now for any lawyer to proclaim that he and his office are "mass tort" lawyers. The label does violence in my opinion to those who work tirelessly, in sometimes hostile jurisdictions, to gain a measure of justice against seemingly insurmountable odds when harmed by a drug. Rick's work tells you all you need to know about him. He ran to the battle not from it. 
Read the opinion.  Give him a call or find his email online and send a note.   "There are big days and there are small days" (Warhorse) and the day the opinion was issued was a big day. 

There is more work to do in that case of course. Rick, good work and good luck. 

Tuesday, March 26, 2013

Are Lawyers Squandering the Chance to Tell Stories about Justice?

I work for innocent people hurt by another's wrongdoing. Some people call me a personal injury lawyer. Whether that term is fair or not, many lawyers out there work in that area of the law.

What's troubling to me is how the media  -- along with the insurance and business industries -- have branded the work I do and the justice we get for hardworking Americans. When there is a story about a verdict, the headline screams something like, "$4 Million for man killed in truck collision." To me, it dehumanizes the victim and reduces that person's tragedy to a dollar amount. It's shameful.

Once social media and the various sites across the internet became reliable sources of news (as opposed to newspapers and radio/TV), I had hopes that somewhere, somehow the real stories would be told about how there was a permanent, and life changing tragedy underlying any jury verdict. Unfortunately, this has not yet happened with media. Worse, lawyers have not helped explain in basic terms how justice was handed down. This failure has happened despite the near limitless tools that allow lawyers like me to spread the word-, Blogs, Facebook, Twitter, Youtube, even Vimeo.

So, now I call on injury lawyers to tell the rest of the story when the media fails to do so about a verdict.

Recently, there was a jury verdict in New Mexico. Here's the headline and the story:

$58M verdict in death suit could be New Mexico "recordLink here

The newspaper breathlessly describes the loss of a husband and father as a "record," like running the fastest 
in the Olympics, or swallowing the most live fish in one sitting.  This man's life was more than that. As the article pointed out,

" Bill Robins, the lead trial attorney for Udy’s estate, said the jury agreed that the Defendants'  truck driver  had been inadequately trained, and that the Defendant employer had a record of past safety violations ...  To the family, we understand that there is no way to put a monetary value on a human life. We trust that Kevin’s children will remember their father, will continue to live their lives in a manner that will honor his memory, " Robins. 

Unfortunately, most news outlets were too lazy to report a little more in depth. See here.  In the first reports, the lawyer wasn't named or quoted. 

As injury lawyers, I and others owe it to the families of folks like the Udy family to tell the rest of the story. So what do some do? Lawyers write this (on Twitter)

Chicago Jury awards $8M to family of woman fatally struck on I-294,

ATTN Hip Implant Recipients: ASR XL hip implant suit against DePuy Inc has resulted in a $8.3 million jury verdict

J&J lost first of 10,000+ lawsuits over faulty hip replacements. The verdict: $8.3 million in damages

Vaginal Mesh Lawsuit Awards $3.5 Million: Vaginal Mesh Verdict on February 25, 2013

My advice to lawyers who have blogs, use Twitter, or Facebook: Change the conversation. Tell the story. Even if the lead is something simple like, "Family waits 4 years to get justice in New Mexico." Lawyers collectively have the power of many. 

Will you change your headline, or will you just parrot the headline? I plan to do a better job too.

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).

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.


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.

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 reactions, 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? 

File:Signs and symptoms of anaphylaxis.png

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.

Monday, March 25, 2013

Anemia Drug Omontys Faces Scrutiny after Recall

From the FDA disturbing news on a recall of Omontys

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.
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.

Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination

From the FDA, news of another recall from a compounding facility. Somehow the shouts for regulation by the FDA of these facilities seems to be stuck in quicksand. Even if there is some type of reform, the FDA is grossly underfunded.

 March 20, 2013 – Tinton Falls, NJ., Med Prep Consulting, Inc. is voluntarily recalling all lots of all products compounded at its facility. The level of recall is to the user, that is, regional hospital pharmacies and related departments, and physician’s office practices. The recall resulted from the pharmacy being notified by a Connecticut hospital, that it observed visible particulate contaminants in 50 ml bags of MAGNESIUM SULFATE 2GM IN DEXTROSE 5% IN WATER, 50ML FOR INJECTIONintravenous solution confirmed to be mold. These were unique and distinct lots compounded and dispensed by the pharmacy to the Connecticut hospital. At this time a total of five (5) contaminated bags were discovered. In an abundance of caution, the pharmacy included all compounded products in the voluntary recall due to lack of sterility assurance.
Administration of an intravenous product found to be contaminated with mold, could result in a fatal infection in a broad array of patients. To date, no injuries or illnesses have been reported.
The products are used for a wide range of therapeutic uses for hospitalized inpatients and outpatients, and, patients directly treated by a health care professional at a physician’s office practice facility or clinic. None of these products are dispensed directly to patients from retail pharmacies or to home care patients for either self-administration or nursing administration. All products are packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials. Products packaged in plastic infusion bags, plastic infusion devices, plastic syringes and glass vials were distributed directly to regional hospital pharmacies located in New Jersey, Pennsylvania, Connecticut, and Delaware. Products packaged in plastic syringes only, were distributed nationwide to physician’s office practice facilities and clinics. All of these products were distributed to the described users through March 17, 2013, from Tinton Falls, New Jersey to both regional and nationwide locations.
All facilities that received any product compounded by Med Prep Consulting, Inc. have been notified by telephone fax, electronic mail and regular mail of the recall and have been instructed to remove and return the product to the pharmacy. Facilities with questions may contact the company at 732-493-3390, Monday through Friday, between 10:00 a.m. and 5:00 p.m. EST.

FDA: Undisclosed Soy in Product Means Recall

The FDA has announced that New Chapter Inc. is voluntarily recalling a limited number of packages of its 90-count Probiotic Elderberry dietary supplement because it may contain an undisclosed allergen -- soy. 
"People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume this product," the FDA said Thursday. " There have been no illnesses reported to date in connection with this product. This product is a food safety concern only for people who are allergic to soy."
The product is packaged in a 90-count amber glass jar with an outer cardboard carton that reads:
Probiotic Elderberry
Lot#: 01230049332
Expiration date: 01/31/15 (located on the bottom of the box and on the side of the bottle) 
:  7-27783-00123-8

More here:

Thursday, March 21, 2013

FDA: Recall of Avastin eye injections linked to infection

The Food and Drug Administration is warning doctors that a compounding pharmacy is recalling dozens of lots of the Roche drug Avastin after receiving reports of eye infections among patients.
The FDA said Wednesday that Clinical Specialties of Martinez, Ga., has received five reports of eye infections from physicians who used the drug to treat macular degeneration.
From the FDA
ISSUE: Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.

BACKGROUND: This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes (see Press Release for a list of lot numbers). This product would be administered by a licensed physician in a surgery or physician’s office setting and syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.

Clinical Specialties is voluntarily recalling Avastin unit dose syringes.
The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.
This product was being used solely as an off label use by an ophthalmologist for macular degeneration and is packaged in sterile syringes. The affected product name lots are as follows:
Lot Number Exp. Date Lot Number Exp. Date
CABDAHAC:39 5/8/2013 CABDACAB:56 4/2/2013
CABDAGAC:58 4/13/2013 CABDACAB:76 4/2/2013
CABDAHAC:77 4/8/2013 CABDACAB:89 4/2/2013
CABDBIAC:86 4/19/2013 CABDADAB:69 4/3/2013
CABDCFAC:29 4/26/2013 CABDADAB:93 4/3/2013
CABDAEAD:26 5/3/2013 CABDADAB:54 4/3/2013
CABDAEAC:47 5/5/2013 CABDAEAB:96 4/4/2013
CABDAEAC:58 5/5/2013 CABDAHAB:00 4/7/2013
CABDAFAC:46 5/6/2013 CABDAHAB:59 4/7/2013
CABDAIAC:46 5/9/2013 CABDAHAB:18 4/7/2013
CABDBCAC:94 5/13/2013 CABDAJAB:30 4/9/2013
CABDCCAC:26 5/23/2013 CABDAJAB:70 4/9/2013
CABDCFAC:81 5/26/2013 CABDAJAB:97 4/9/2013
CABDABAD:05 5/30/2013 CABDBAAB:63 4/10/2013
CABDAFAC:47 5/6/2013 CABDBAAB:77 4/10/2013
CABDAGAC:43 5/7/2013 CABDBAAB:54 4/10/2013
CABDBDAC:69 5/14/2013 CABDBAAB:04 4/10/2013
CABDBIAC:77 5/19/2013 CABDBEAB:97 4/14/2013
CABDCHAC:19 5/28/2013 CABDBFAB:67 3/16/2013
CABDAHAD:21 6/5/2013 CABDBFAB:61 4/15/2013
CABDCFAC:17 5/26/2013 CABDBFAB:84 4/15/2013
CABDAHAD:00 6/5/2013 CABDBGAB:34 4/16/2013
CABDBCAC:47 5/13/2013 CABDBHAB:33 4/17/2013
CABDCBAC:97 5/22/2013 CABDBHAB:71 4/17/2013
CABDAGAC:08 5/7/2013 CABDBHAB:75 4/17/2013
CABDBCAC:15 5/13/2013 CABDCBAB:66 4/21/2013
CABDBDAC:17 5/14/2013 CABDCCAB:64 4/22/2013
CABDCIAC:42 5/29/2013 CABDCDAB:38 4/23/2013
CABDBEAC:44 5/15/2013 CABDCEAB:71 4/24/2013
CABDCBAC:79 5/22/2013 CABDCEAB:04 4/24/2013
CABDCIAC:00 5/29/2013 CABDCFAB:22 3/26/2013
CABDAHAD:82 6/5/2013 CABDCFAB:14 4/25/2013
CABDCBAC:31 5/22/2013 CABDCIAB:51 4/28/2013
CABDCIAB:68 4/28/2013 CABDCIAB:93 3/29/2013
CABDCJAB:59 4/29/2013 CABDDBAB:71 4/1/2013
CABDDBAB:93 5/1/2013 CABCBJBC:00 3/19/2013
CABCCGBC:92 2/24/2013 CABCCGBC:30 3/26/2013
CABCCGBC:49 3/26/2013 CABCCHBC:55 3/27/2013
CABCCIBC:39 3/23/2013 CABCDBBC:87 3/31/2013
CABCDBBC:71 3/1/2013    
This product would be administered by a licensed physician in a surgery or physician’s office setting. The syringes were distributed to doctors’ offices in Georgia, Louisiana, South Carolina, and Indiana from December 18, 2012 to present.
Clinical Specialties has notified the physician’ offices by telephone. Doctors that have product which is being recalled should stop using the Avastin immediately.
Consumers with questions regarding this recall may contact Clinical Specialties by phone at 866.880.1915 or e-mail address at ; Monday through Friday between the hours of 10 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.