Tuesday, October 29, 2013

University Compounding Pharmacy Initiates a Nationwide Recall

University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level.  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. 
The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013. The preparations would have been sold, directly to customers by pick up and by mail from;
University Compounding Pharmacy 1875 3rd Avenue San Diego CA. 92101. 619) 683-2005
Product NameLot NumberExpiry
Testosterone Cypionate (Sesame Oil) 200mg/mL Inj.51101711/30/2013
Testosterone Cypionate/Testosterone Proprionate 180-20mg/mL Inj51359311/30/2013
PGE-1 NS 20mcg/mL Inj.4979409/6/2013
PGE-1 NS 100mcg/mL Inj.49793011/5/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.4986169/25/2013
University Compounding Pharmacy 1765 4th Avenue San Diego CA. 92101. 619) 398-1800
Testosterone CYP (Sesame Oil) 200mg/mL Inj.4743239/13/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.4754759/26/2013

Specialty Medicine Compounding Pharmacy: Recall of Compounded Sterile Products

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.
Specialty Medicine Compounding Pharmacy has not received any reports of adverse events related to this recall. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013.  No products were distributed out of state.
All unexpired lots of the following compounded products are subject to the recall:
Human Products
Acetylcysteine, 5%Acetylcysteine, 10%Acetylcysteine, 20%
Aluminum Potassium SulfateAminophylline PF, 25mg/mlBevacizumab, 0.06ml (repackaged)
Bevacizumab, 0.11ml (repackaged)Bi-Mix, 15mg/0.5mgBiotin IM, 1mg/ml
Calcium Chloride PF, 500mg/mlCeftazidime, 22.5mg/ml (ophthalmic)Clorpactin, 0.1%
Combo Eye GelCyanocobalamin, 1000mcg/mlCyclopentolate HCL, 2% (ophthalmic)
Dexamethasone NaPO4  ionto-pf, 4mg/mlDextrose Vial, 50%DMSO/Glutath, 3.75%/1.75% (ophthalmic)
Edetate Disodium (0.05m), 1.7%Epinephrine (PF/SF), 0.5ml in 3mlEpinephrine PF SF (0.3ml), 1:1000
Epinephrine PF SF (1ml), 1:1000Fentanyl PF, 50mcg/mlFluconazole/Gentamicin, 200mg/480mg/1L
Fluorouracil PF, 50mg/mlGatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged)Glutathione PF, 60mg/ml inhalation
Glycerin-Chromated (w/v), 72%Hyaluronidase, pf 100U/mlHyaluronidase, pf 150U/ml
Hydroxocobalamin, 10,000mcg/mlHydroxocobalamin/thiamine, 1mg/100mg/mlLidocaine/Sodium Chloride, 0.4%/18%
Magnesium Sulfate, 1gm/50mlMagnesium Sulfate, 2gm/50mlMethocarbamol, 100mg/ml (repackaged)
Methylcobalamin, 1000mcg/mlMethylcobalamin, 10mg/mlMethylcobalamin, 25mg/ml
Methylcobalamin, 5000mcg/mlMethylcobalamin, PF 25mg/mlMultitrace-4 Pediatric Injection
Naloxone HCL, 0.4mg/mlNaltrexone MCV, 1mg/mlNeomycin, 333mg/ml
Papav/Phentol/PG E1, 30mg/1mg/20mcg/mlPapaverine HCL, (10ml) 30mg/mlPapaverine HCL, (2ml) 30mg/ml
Papaverine HCL, 30mg/mlPhenol, 6%Phenylephrine/Tropicamide, 2.5%/1% (ophthalmic)
Polidocanol, 1%Polidocanol, 3%Potassium Phosphate, 4.4meq/3mmol/ml
Proparacaine HCL PF, 0.5% (ophthalmic)Quad Mix, 0.05mg/25mg/2mg/25mcg/mlQuad Mix, 0.1mg/30mg/2mg/20mcg/ml
Quad Mix, 0.1mg/30mg/2mg/50mcg/mlQuad Mix, 0.1mg/9mg/1mg/10mcg/mlQuad Mix, in NaCl (1.8/0.2/0.02)mg/18mcg/ml
Sodium Chloride, 0.9% (repackaged)Sodium Chloride, PF 14.6%Sodium Phosphate, PF 3mmol/ml
Sodium tetradecyl SO4, 3%Sodium Thiosulfate PF, 10%Super Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Testos Cypionate in Oil, 100mg/mlTestos Cypionate in Oil, 200mg/mlTestos Cypionate in Olive Oil, 200mg/ml
Tranexamic Acid, 2gm/100mlTranexamic Acid, 2gm/75mlTriple Mix, 15mg/0.5mg/10mcg/ml
Triple Mix, 15mg/1mg/20mcg/mlTriple Mix, 30mg/1mg/10mcg/mlTriple Mix, 30mg/1mg/20mcg/ml
Triple Mix, 30mg/1mg/40mcg/mlTropicamide, 1%Vancomycin HCL, 10mg/ml (ophthalmic)
Vigamox in BSS (0.15%), 0.75mg/0.5ml  
Veterinary Products
Amikacin Sulfate, 250mg/mlBuprenorphine HCL, 0.3mg/mlBuprenorphine HCL, 0.6mg/ml
Ceftazidime in pluronic 250mg/ml gelCyclosporin A Oint, 0.2% (ophthalmic)Cyclosporin MCT, 0.2% (ophthalmic)
Cyclosporin MCT, 1% (ophthalmic)Desmopressin Acetate (0.01%), 0.1mg/mlDesmopressin Acetate (0.0125%), 0.125mg/ml
Desmopressin Acetate (0.02%), 0.2mg/mlDiclofenac Sodium Oint, 0.1% (ophthalmic)Idoxuridine Ophthalmic, 0.1%
Phenobarbital Sodium, 65mg/mlPrednisone, 10mg/mlTacrolimus, 0.02% (ophthalmic drops)
Tacrolimus, 0.03% (ophthalmic drops)Tacrolimus Ointment, 0.03% (ophthalmic)Ticarcillin in Pluronic, 250mg/ml gel
Xylazine 100mg/ml  
Specialty Medicine Compounding Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. Customers with questions regarding this recall may contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT.
Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:

FDA takes enforcement action against Oregon dietary supplement manufacturer

The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under Cole’s custody and control.
“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”
James G. Cole, Inc. has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics, and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.
Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.
The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.

Thursday, October 24, 2013

Meningitis Outbreak, NECC Bankruptcy and the NEJM

On the heels of the New England Compounding Pharmacy's Bankruptcy process moving along with a Notice to Creditors being mailed (The forms are due back in January of 2014) there is a report of a NEJM article on the illnesses suffered by innocent consumers who had NECC products put in their bodies.  

The New England Journal of Medicine has a study out, Clinical Findings for Fungal Infections
Caused by Methylprednisolone Injections. According to the NEJM, the authors reviewed medical records for outbreak cases reported to the Centers for Disease Control and Prevention before November 19, 2012, from the six states with the most reported cases (Florida, Indiana, Michigan, New Jersey, Tennessee, and Virginia). Polymerase-chain-reaction assays and immunohistochemical testing were performed on clinical isolates and tissue specimens for pathogen identification.


It 's worth reading.

Trial Lawyer Blog Debuts: Trial Lawyer Center

www.triallawyercenter.com is  up and running. It's an effort from several trial lawyers from across the country. Interesting content with more to come. I'm one of the contributors.

Take a look and tell me what you think.

October 2013 News: OxyELITE Pro gets a Warning Letter from the FDA

Fda (Photo credit: Wikipedia)

This letter concerns your products Oxy Elite Pro and VERSA-1 that are labeled and/or promoted as dietary supplements. The labeling for these products declares aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, as a dietary ingredient.
The term "dietary supplement" is defined in 21 U.S.C. 321(ff) [section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act)]. Given that you declared aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, as a dietary ingredient in the labeling of your products, we assume you have a basis to conclude that aegeline is a “dietary ingredient” under 21 U.S.C. 321(ff)(1). Assuming that aegeline is a "dietary ingredient," it would also be a “new dietary ingredient” for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6.
Under 21 U.S.C. 350b, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under 21 U.S.C. 342(f) unless it meets one of two requirements:
  1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
  1. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
FDA is not aware of any information demonstrating that aegeline was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is FDA aware of any information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information, aegeline is subject to the notification requirement in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. Because the required notification has not been submitted, your products are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).
In the absence of a history of use or other evidence of safety establishing that aegeline, when used under the conditions recommended or suggested in the labeling of your products, will reasonably be expected to be safe, Oxy Elite Pro and VERSA-1 are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because they contain a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v).  FDA is aware of no history of use or other evidence of safety establishing that aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of OxyElitePro and Versa-1.
The importance of establishing that products containing aegeline will reasonably be expected to be safe when used under the conditions recommended or suggested in the labeling of your product is particularly important in the present setting where public health officials in Hawaii and elsewhere within the United States are actively investigating a number of severe illnesses characterized by hepatotoxicity where affected patients report using a product labeled as Oxy Elite Pro. Several findings suggest a causal connection may exist between ingestion of a product labeled as Oxy Elite Pro and the illnesses reported in Hawaii. First, in a review of twenty (20) medical records submitted to FDA by the Hawaii Department of Health, the records indicated that fourteen (14) patients (70%) had ingested a product labeled as Oxy Elite Pro prior to becoming ill. There were no other consistent commonalities among the fourteen (14) patients other than exposure to Oxy Elite Pro. Importantly, eight (8) patients reported Oxy Elite Pro as the sole dietary supplement they took prior to becoming ill, and most of these patients had been entirely healthy before they became ill. Second, upon discontinuing Oxy Elite Pro following onset of illness, most patients recovered from their illness, implying Oxy Elite Pro was the cause of the illness. Unfortunately, several patients sustained injuries to the liver that required transplantation, and one patient died before transplantation could be undertaken. And finally, rigorous clinical protocols were followed in the care of the patients to exclude and/or rule out known causes of liver disease (e.g., viral causes of hepatitis, autoimmune conditions, hemochromatosis, Wilson’s disease, excess alcohol or acetaminophen ingestion, and alpha-1-antityrpsin deficiency). The absence of these causes of liver disease increases the likelihood that Oxy Elite Pro played a hepatotoxic role in these patients. Therefore, in the absence of a history of use or other evidence of safety establishing that aegeline is reasonably expected to be safe under the conditions recommended or suggested in the labeling of Oxy Elite Pro and VERSA-1, your products are deemed to be adulterated under 21 U.S.C. 342(f).
We request that you take prompt action to correct these and any other violations associated with Oxy Elite Pro and VERSA-1 and any other products marketed by your firm that contain aegeline. We again remind you that the notification requirement for a new dietary ingredient applies to any dietary supplement that contains a new dietary ingredient that has not been present in the food supply as articles used for food in a form in which the food has not been chemically altered.
Failure to immediately cease distribution of all products containing aegeline may result in enforcement action by FDA without further notice. The Act provides various tools to remedy adulterated or misbranded foods, including administrative detention order(s) and seizure(s) against adulterated or misbranded food products in the marketplace, injunction against the manufacturers and distributors from further violating the Act, and criminal sanctions against persons responsible for causing violations of the Act.
We request that you advise us in writing, within fifteen (15) working days of receiving this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to adulterated product currently in the marketplace. Your response should also include an explanation of each step taken to assure that similar and repeated violations do not recur, as well as documentation to support your response. Please submit your response to Mr. Quyen Tien at the above letterhead address. Please provide a copy of your response to Mr. Reynaldo R. Rodriguez, Jr., Dallas District Director, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions, please contact Mr. Tien at 215-717-3705.
William A. Correll Jr
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition
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Florida USDCT Judge Strikes Down FL's New Medical Malpractice Law

A federal judge has struck down a key Florida medical malpractice law that required a patient to allow a defending physician’s attorney to informally discuss the case with the patient’s other health care providers. The law would have allowed those discussions to take place without the patient or their representative being present.
U.S. District Judge Robert Hinkle ruled the state law violates the patient consent provisions of the federal Health Insurance Portability and Accountability Act (HIPAA). Under previous longstanding law, a patient seeking to file a medical malpractice claim against a physician had to provide the physician with a pre-suit notification.
Earlier this year Florida lawmakers added a new requirement that as of June 1, the pre-suit notification must include the patient’s authorization allowing a defending physician, the physician’s attorney, insurer and adjuster to hold ex parte discussions with the patient’s previous and subsequent health care providers without the patient and/or their attorney being present.
Here's the Order:

Wednesday, October 23, 2013

10/23/13 Bankruptcy Court Approves NECC Litigation Proof of Claim

I'm one of seven attorneys appointed by the  Federal Court to oversee the litigation as part of the Plaintiffs' Steering Committee.   Recently, in Bankruptcy Court, a proof of claim form was approved and mailed. The Court and the Trustee just started mailing out this claim form. The proof of claim form must be completed by an injured party in order to preserve the right to bring a monetary claim against NECC. Anyone who was potentially injured by the tainted steroid injections must submit the proof of claim form by January 15, 2014 to be considered in any settlement negotiations.

The first question I'm being asked is - what do the papers say, and must I sign and return them? In truth, the first question is- have you read the full form? Here is what it looks like:

I've practiced law for more than 20 years. I've been involved in this case from its inception. There are many questions still unanswered for people who had NECC product put in their bodies, and I'm happy to talk with you.

Tuesday, October 22, 2013

Januvia update for October 2013

In light of this science, our firm has been investigating and filing lawsuits on behalf of Byetta, Januvia, Victoza and other “Incretin-based therapy” users who developed pancreatitis or pancreatic cancer. As of this month, there are two venues: One a single “judicially coordinated” proceeding involving multiple pancreatic cancer lawsuits in California state court (administered by Judge William Highberger in Los Angeles), and two,a federal “multidistrict litigation” proceeding (typically called an “MDL”) in front of federal Judge Anthony Battaglia in the Southern District of California.

Diabetes medications work by affecting the GLP-1 therapy. As such, there is a claimed risk of   pancreatic cancer.Here's the drug list:

1. Byetta (April 28, 2005) (Amylin / Ely Lilly)
2. Bydureon (January 27, 2012) (Amylin / Eli Lilly)

  Victoza (January 25, 2010) (Novo Nordisk)

  Januvia (October 16, 2006) (Merck)
  Janumet (March 30, 2007) (Merck)
  Janumet XR (February 2, 2012) (Merck)
  Juvisync (October 7, 2011) (Merck)

  Onglyza (July 31, 2009) (Bristol Myers Squibb)
  Kombiglyze XR (November 5, 2010) (Bristol Myers Squibb)

  Nesina (January 25, 2013) (Takeda)
  Kazano (January 25, 2013) (Takeda)
  Oseni (January 25, 2013) (Takeda)

  Tradjenta (May 2, 2011) (Boehringer Ingelheim)
  Jentadueto (January 30, 2012) (Boehringer Ingelheim)

Pancreatic cancer is a malignant neoplasm originating from transformed cells arising in tissues forming the pancreas. The most common type of pancreatic cancer, accounting for 95% of these tumors, is adenocarcinoma (tumors exhibiting glandular architecture on light microscopy) arising within the exocrine component of the pancreas. A minority arise from islet cells, and are classified as neuroendocrine tumors. The signs and symptoms that eventually lead to the diagnosis depend on the location, the size, and the tissue type of the tumor, and may include abdominal pain, lower back pain, and jaundice (if the tumor compresses the bile duct).

Lyophilized Products Compounded by NuVision Pharmacy: Recall - Sterility Assurance Concerns

NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.

BACKGROUND: These products were supplied to the offices of licensed medical professionals. NuVision Pharmacy’s sterile products covered under this recall were distributed nationwide. To date, NuVision Pharmacy has received no reports of injury or illness associated with the use of our sterile products. However, out of abundance of caution and in the interest of our patients, NuVision Pharmacy has decided to voluntarily proceed with this recall process.


Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning

News this month on changes to the label of Rituxan: 

FDA approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk.

In patients with prior HBV infection, HBV reactivation may occur when the body’s immune system is impaired. HBV reactivation has occurred in patients with prior HBV exposure who are later treated with drugs classified as CD20-directed cytolytic antibodies, including Arzerra (ofatumumab) and Rituxan (rituximab). Some cases have resulted in fulminant hepatitis, hepatic failure, and death.

To decrease the risk of HBV reactivation, FDA recommends that health care professionals:
  • Screen all patients for HBV infection before starting treatment with Arzerra or Rituxan by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc).
  • Consult with hepatitis experts regarding monitoring and use of HBV antiviral therapy when screening identifies patients at risk of HBV reactivation due to evidence of prior HBV infection.
  • Monitor patients with evidence of prior HBV infection for clinical and laboratory signs of hepatitis B or HBV reactivation during Arzerra or Rituxan therapy and for several months thereafter, since reactivations have occurred several months following completion of therapy with these drugs.
  • In patients who develop reactivation of HBV while on Arzerra or Rituxan, immediately discontinue the drug and start appropriate treatment for HBV. Also discontinue any chemotherapy the patient is receiving until the HBV infection is controlled or resolved.  Because of insufficient data, no recommendation can be made regarding the resumption of Arzerra or Rituxan in patients who develop HBV reactivation hepatitis.
For Patients:
  • Before receiving Arzerra or Rituxan, tell your health care professional if you have or have had any severe infections, including HBV.
  • If you have had HBV infection, your health care professional should monitor you for HBV infection during treatment and for several months after you stop treatment with Arzerra or Rituxan.

Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall

It's been a busy few days for the FDA  post-shutdown:

Nephron Pharmaceuticals initiated a voluntary recall, at the retail level, of ten lots of product due to results from an internal monitoring process. NPC performs aseptic process simulation as part of an internal processes to assure product quality. All of the lots listed above met and passed NPC’s quality specifications at the time of manufacture. In accordance with published guidance regarding aseptic processing simulation from the FDA, NPC has initiated this recall as a precautionary measure.

BACKGROUND: The affected product is identified as Albuterol Sulfate Inhalation Solution, 0.083%, in the 25 count packaging configuration (NDC# 0487-9501-25) and lots A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.


Hospira brand Lidocaine and Marcaine: Recall - Presence Of Particulate

From the FDA:

Hospira announced a nationwide recall to the user level for one lot of 0.25% Marcaine (Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed customer report of discolored solution with visible particles inside the glass vial as well as embedded in the glass. See firm's press release below for further information.

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

Dräger recalls Fabius anesthesia machines

From the FDA:
Dräger has issued a statement regarding its recall on specific Fabius anesthesia machines. Investigations determined that on some power supply units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained. In extreme cases, the influence of mechanical forces, such as movement of the device, for example, may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected. To date, there have been no reported injuries or reported failures due to this issue.

BACKGROUND: This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013 and May 2013 and distributed in the United States between March 2013 and June 2013. Affected devices were distributed nationally (see firm press release for information on affected serial numbers by model).

RECOMMENDATION: If users of the Fabius anesthesia machines experience such a failure of the automatic ventilation function, they should switch over to the manual ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob, and start manual ventilation. Additional details concerning switching to manual ventilation in case of a fault are provided in the Instructions for Use in the Fault-Cause-Remedy and Ventilator Fail Safe sections. Hospitals are urged to notify their personnel accordingly.

Monday, October 21, 2013

Slim Fortune, Lidiy, and Slim Expert Recalled

B@B Trade of Florida is recalling all lots of Slim Fortune, Lidiy, and Slim Expert because they contain undeclared sibutramine, a previously controlled substance that was removed from the marketplace in 2010.

Sibutramine substantially increases blood pressure and/or pulse rate in some patients and may present a significant health risk to those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The product can also interact in life-threatening ways with other medications.

Sibutramine (usually in the form of the hydrochloride monohydrate salt) is an oral anorexiant. Until 2010 it was marketed and prescribed as an adjunct in the treatment of exogenous obesity along with diet and exercise. It has been associated with increased cardiovascular events and strokes and has been withdrawn from the market in countries and regions.


Ten Lots of Albuterol Inhalation Solution Recalled

Nephron Pharmaceuticals Corp (NPC) has initiated a voluntary recall at the retail level of 10 lots of albuterol sulfate inhalation solution, 0.083%.

The recall affects albuterol sulfate inhalation solution, 0.083%, in the 25-count packaging configuration with national drug code (NDC) 0487-9501-25.
The 10 affected lots are: A3A33A, A3A33B, A3A34A, A3A35A, A3A36A, A3A37A, A3A38A, A3A40A, A3A41A, and A3A42A.


Antibiotic Cefepime Recalled Due to Visible Particles

Federal health officials are alerting doctors to the recall of an injectable antibiotic made by B. Braun Medical, due to floating particles found in plastic containers of the drug.

The Food and Drug Administration posted the notice late Tuesday, warning health professionals that the company has recalled lot H3A744 of its Cefepime for Injection USP and Dextrose Injection USP. Visible organic particles were found in a sample from the lot.

The agency warned that using the drug could result in blood clots causing stroke, heart attack and other catastrophic problems.

The drug was distributed to hospitals, pharmacies and medical suppliers nationwide, according to the agency's release.


Wednesday, October 16, 2013

Craze Supplement - Sales Suspended

News from USA Today:

The maker of the popular sports supplement Craze, which scientists say contains a  methamphetamine-like compound, revealed Tuesday that it has suspended all production and sales of the product.

Earlier this week a team of scientists from the U.S. and the Netherlands published an article in the peer-reviewed scientific journal Drug Testing and Analysis saying they had identified an analog — or chemical cousin — of methamphetamine in samples of Craze. They warned that the chemical has never been studied in humans, that the health risks are unknown and that it is not disclosed on Craze's label.

From the journal:

 Pharmaceuticals and banned substances have been detected in hundreds of purportedly natural supplements. Recently, several athletes have been disqualified from competition after testing positive for the methamphetamine analog N,α-diethyl-phenylethylamine (N,α-DEPEA). Athletes have claimed they unknowingly consumed the banned stimulant in workout supplements. Three samples from different lot numbers of Craze, a workout supplement, were analyzed to detect the presence and concentration of N,α-DEPEA. Two labs independently identified N,α-DEPEA in the supplement using ultra high performance liquid chromatography (UHPLC) coupled to an LTQ Orbitrap XL mass spectrometer and UHPLC-quadruple-time-of-flight mass (Q-TOF) spectrometer, respectively. The identity of N,α-DEPEA was confirmed using nuclear magnetic resonance and reference standards. Manufacturer recommended servings were estimated to provide 21 to 35 mg of N,α-DEPEA. N,α-DEPEA has never been studied in humans. N,α-DEPEA is a methamphetamine analog; however, its stimulant, addictive and other adverse effects in humans are entirely unknown. Regulatory agencies should act expeditiously to warn consumers and remove N,α-DEPEA from all dietary supplement.


Thursday, October 10, 2013

OxyElite Pro, Recalled Hydroxycut and claimed Liver Injuries - Lessons?

In May 1, 2009 14 different different Hydroxycut products were taken off the market. Across the USA, there were news reports of  that the FDA had received 23 reports of liver problems, including a death allegedly from one of the products.  I've been involved in the Hydroxycut litigation as a member of the Plaintiffs Steering Committee in San Diego for more than three years.

In the aftermath of that product recall, public health researcher Ano Lobb, who studied Hydroxycut and other dietary supplements for Consumer Reports, was quoted as saying that the one of the problems may have been an ingredient called hydroxycitric acid. This ingredient is derived from a tropical fruit and has been linked to liver problems in at least one medical journal study. Lobb said it may be that other supplements containing the same ingredient remain on the market.

"You really have to be careful about dietary supplements, especially weight-loss pills," said Lobb. "People believe that the FDA has verified that these products are at least safe and effective, and that's really not the case. When you see fantastic claims - that's generally what they are."


For OxyElite Pro, could the issues that so far have been confined to Hawaii relate to the product's reformulation? For Hydroxycut, health officials said they were unable to determine which Hydroxycut ingredients were potentially toxic, partially because the formulation had changed several times.

From the time it reached the shelves across America until mid-2013, Oxy contained DMAA. According to the FDA DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient "found illegally in some dietary supplements and often touted as a natural stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. http://www.fda.gov/food/dietarysupplements/qadietarysupplements/ucm346576.htm 

After the Department of Defense removed the shelves, and after the FDA actually seized Oxy from several distribution centers, USP reformulated Oxy. The reasons for this product ingredient change may never be made known to consumers, but the simple fact remains - DMAA was removed and a "new" Oxy went on the market.

Here's the new label for OxyElite:

On the bottles, here is what some consumers may have seen:

What's different from Oxy with DMAA?

What does a consumer do? The old version of Oxy told potential buyers that the product was "University Studied" while the new formulation says that Oxy is "Scientifically Reviewed." A change, why? Has it been  been tested by a panel? Is there a peer-reviewed study for the new ingredients?

What's in this stuff? Bauhinia purpurea: A shrub that is commonly grown in Asia and employed extensively in Ayurvedic medicine. Bauhinia purpurea has been used traditionally to treat ailments such as sores, wounds and diarrhea. The chloroform extract of Bauhinia purpurea contains bioactive compounds with potential peripheral and central antinociceptive and anti-inflammatory activities. Animal studies suggest that Bauhinia helps maintain thyroid hormone levels. However, no similar clinical studies involving Bauhinia have been carried out. Bauhinia purpurea has not been approved for use by the Food and Drug Administration according to the FDA site and our research.

Cirsium oligophyllum: Use of this plant in the OxyElite Pro formulation may be based on an animal study (Int J Biol Sci 2009;5(4):311-318) which suggested that the extract could reduce bodyweight and fat mass, and appeared to specifically target subcutaneous fat mass rather than visceral fat mass.

Aegeline as well as Yohimbe are also in the new Oxy. Yohimbe's warnings include this: People with kidney or liver disease, stomach ulcers, heart disease, high blood pressure, low blood pressure, post-traumatic stress disorder, and panic disorder should not take yohimbe. This ingredient is only approved by the FDA to treat impotence. 


In Hydroxycut, studies gave clues to what ingredient may be a culprit. From the Shim study:

One of the components of Hydroxycut®, Garcinia, has been associated with both hepatocellular and cholestatic pattern of injury and our biopsy was suggestive of cholangitis likely secondary to infectious or drug mediated injury. Extensive evaluation for infectious disease by an infectious disease specialist failed to diagnose any infection and fevers can be associated with drug induced hepatotoxicity and can last weeks. The authors initially placed the patient on broad spectrum antibiotics while we waited for diagnostic studies to return. He also had severe leukocytosis with a left shift to suggest a bacterial etiology but did not have any significant improvement in jaundice with antibiotics and later gradually improved without them. While causation is difficult to prove in any drug induced injury, the temporal relationship after Hydroxycut® exposure and gradual improvement after withdrawing the involved medication plus absence of any other etiologies despite comprehensive testing would point to Hydroxycut® being the most likely possible cause for hepatotoxicity. Earlier reports from Dara et al with case series of 2 patients have shown a similar temporal relationship, also present histological data for possible association with drug toxicity. 


The challenge will be getting the company to disclose what amounts of each ingredient were in this product. 


Standard Homeopathic Company gets an FDA Warning Letter

Here's new about a recent Warning Letter issued by the FDA to Standard Homeopathic Company,

The Warning Letter to your company on April 29, 2011 discussed primarily current good manufacturing practices (cGMPs) and only a small sample of your firm’s misbranded drugs. In the 2011 warning letter and in subsequent communications with your firm, the Food and Drug Administration (FDA or Agency) has repeatedly reminded your firm to take a broad approach to your labeling and review the indications for all your products. In May 2013, FDA conducted a more detailed review of your labeling and marketing information for your firm’s homeopathic drug products found on your website at http://www.hylands.com. FDA also reviewed your website www.hylandsearache.com in September 2013. This review revealed that your firm markets numerous drugs that are misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 353 and 331] including, but not limited to: “Arnicaid,” “Arthritis Pain Formula,” “Earache Tablets,” “Earache Drops,” “Infant Earache Drops,” “Hyland’s Kid’s Kit,” “Restful Legs,” “Teething Tablets,” “Teething Gel,” “Vaginitis,” “Antimonium Tartaricum,” “Arsenicum Album,” “Belladonna,” “Bryonia Alba,” “Cell Salts: #4 Ferrum Phos, #6 Kali Phos, #7 Kali Sulph, #8 Mag Phos, #11 Nat Sulph, #12 Silica,” “Chamomilla,” “Ferrum Phosphoricum” “Hepar Sulphuris Calcareum” “Hypericum Perfoliatum,” “Ipecacuanha,” “Magnesia Phosphorica,” “Mercurius Vivus,” “Nux Vomica,” “Phosphorus,” “Ruta Graveolens,” and “Spongia Tosta.”

Misbranding [§§ 503(b)(4) and 301(a)]

As stated above, FDA reviewed the information on your websites regarding a number of your products. Information on your websites, including the indications associated with each active ingredient, documents the intended uses of your products including, but not limited to the following:

“Hypericum Perfoliatum 6X HPUS – for nerve injuries due to blows.”

Arthritis Pain Formula
“Guaiacum 3X HPUS –acute rheumatism, stiffness and immobility.”

Earache Tablets
The name of product indicates the intended use for earaches.
“For the relief of symptoms of fever, pain, irritability and sleeplessness associated with earaches in children after diagnosis by a physician.”
“The medicines in Hyland’s Earache Tablets have been clinically shown to reduce earache symptoms during the first 48 hours of the episode.”
Take these at the first sign of ‘clogging’ or ear discomfort. They work fast and usually clear symptoms within 24-48 hours. They really do k/o the pain and the all natural ingredients are better, in my opinion, than over prescribing antibiotics for repeat infections. I find them especially helpful for adult ear infections for those of us in tropical or warm climates. A must for chronic otitis externa sufferers.” (consumer review from www.hylandsearache.com)
“Calcarea Carbonica 30C HPUS - for throbbing, pulsing pain in ears.”
“Sulphur 30C HPUS: for ear pain with burning sensation.”

Earache Drops
The name of product indicates the intended use for earaches.
“For the relief of symptoms of fever, pain, irritability and sleeplessness associated with earaches in children after diagnosis by a physician.”
“Unlike conventional swimmer's ear treatments that simply dry the ears, Hyland's Earache Drops work directly to relieve the pain, itch, and congestion associated with swimmer's ear.”
“These drops cleared up my painful swimmers ear within hours! I thought I might even been having a brain tumor, as I was truly suffering and trying to see my doctor on on (sic) a summer Saturday when his office is closed, and was on verge of going to the ER. Inner ear infections can lead to horrible consequences, like permanent loss of balance! Lucky for me I found these drops at a Store on Sixth Avenue. I was skeptical at the high price. But I was in so much pain, and had already tried peroxide, ear wax removal product, and heating pad while all escalated the pain and inner ear swelling. Maybe it was a brain tumor afterall?” (consumer review from www.hylandsearache.com)
“Calcarea Carbonica 30C HPUS - for throbbing, pulsing pain in ears.”
“Sulphur 30C HPUS: for ear pain with burning sensation.”

Read more here: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm370015.htm

Wednesday, October 09, 2013

10/9/13: OxyELITE Pro Nationwide Distribution Stopped

My office has filed a wrongful death case against the makers of OxyELITE Pro. We way that a young healthy woman died from this product, which at the time had DMAA.  News this week about a nationwide story involving the new formulation of this product:

From HuffPo:
Diet supplement manufacturer USPLabs is stopping nationwide distribution of the diet pill OxyELITE Pro in lieu of a staggering number of liver failure cases associated with the supplement, Hawaii News Now reported.The announcement comes shortly after the Hawaii Department of Health requested the “voluntary removal” of OxyELITE Pro from Hawaii retailers, and asked the public to stop any use of the diet supplement. Hawaii DOH linked OxyELITE Pro to 24 recent cases of liver damage across the state, including one death.

What is in the new version of this product? Here's one label found on the web:

This is an example of a label for this product from the internet. Of course, check the label of the product you used if you have concerns. What is the first ingredient that is a concern? Yohimbe, according to several websites has several side effects: 
Side effects are well recognized and may include central nervous system stimulation that causes anxiety attacks. At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken concomitantly with tyramine-containing foods (e.g., liver, cheeses, red wine) or with over-the-counter (OTC) products containing phenylpropanolamine, such as nasal decongestants and diet aids. 
Is an ingredient in the new formuation the culprit? Stay tuned. This product has made the news before. In a previous formulation, it contained DMAA. 

From the FDA:

Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program. 
Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.

Our office filed a case against USP Labs and GNC in June of 2012:

Now, the question is: Did USP rush this  to market without proper testing? Or was the outbreak of incidents in Hawaii a results of one or two bad lots?  

Tuesday, October 08, 2013

OxyElite Pro Linked to 40 Cases of Liver Failure in Hawaii

The Hawaii State Department of Health has confirmed that at least 40 new cases of alleged liver failure have been linked to OxyElite Pro (OEP), a controversial pre-workout and weight loss dietary supplement. 

As a result of these events, the Department of Health sent out an alert to medical professionals around the country requesting that doctors and dietitians report any patients suffering from liver conditions who were taking OxyElite Pro or other similar dietary supplements. The active ingredient in OEP, dimethylamylamine (DMAA), has recently been linked to heart attacks, heat strokes, seizures, liver failure, and death.

Here's video from a Hawaii news station:

 Hawaii News Now - KGMB and KHNL

Sunday, October 06, 2013

Thousands of women reporting severe medical reactions to Essure birth control

Essure is marketed as permanent birth control you can get without having surgery. It's meant to be cheaper, easier and safer than getting your tubes tied. Here is what the FDA site says about this product:

Product Name: Essure™ System
Manufacturer: Conceptus, Inc.
Address: 1021 Howard Ave., San Carlos, CA 94070
Approval Date: November 4, 2002
Approval Letterhttp://www.accessdata.fda.gov/cdrh_docs/pdf2/p020014a.pdf
What is it? A new method of permanent birth control (sterilization) for women. In this system, small metal coils are placed in a woman’s fallopian tubes. Unlike other sterilization procedures for women, this system does not require incisions or general anesthesia. Instead, a doctor implants the coils by threading them through the vaginal opening.
How does it work? The Essure™ System works by blocking the fallopian tubes so that sperm can not fertilize a woman’s eggs. To insert the coils, a doctor uses a special catheter that passes through the vagina and uterus into the fallopian tubes. After the catheter is removed, the coils remain in place permanently. Over time, scar tissue forms around the implants and blocks the fallopian tubes. General anesthesia is not required to perform the implantation procedure.
During the first three months, the woman cannot rely on the Essure™ system and must use another type of birth control. After three months, she will undergo an x-ray procedure to confirm that her fallopian tubes are blocked. If this shows successful blockage, she can stop using her back-up birth control.
When is it used? The Essure™ System is used by women who are sure that they will never want to bear children. This system should be used only by women who can rely on alternative forms of birth control for at least three months after the implant.
What will it accomplish? This system provides permanent female sterilization, without incisions or general anesthesia.
In two clinical studies of the Essure™ System, there were no pregnancies in women who relied on the device for one year (439 women) or for two years (193 women). In about one out of seven women, doctors could not place both Essure™ implants on the first attempt.

During the procedure, two metal coils are placed inside the Fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.

It's been around since 2002. According to the manufacturer, about 750,000 have had it implanted to date.

Adverse Events

Since 2004, 838 women and doctors filed complaints as 'Adverse Events' with the Food and Drug Administration.

Team 10 found:

-- There were 150 complaints where the coils broke or miss-fired;

-- Even more complaints detail the device moving or puncturing the fallopian tube;

-- 80 women became pregnant;

-- 91 reported having hysterectomies to remove the device.

Talk with us if you had this product placed in your body, and now have injuries you think are caused by it. 

Tennessee: Fungal meningitis patient relapsed

I'm one of seven attorneys appointed by Judge F. Dennis Saylor in the MDL litigation in Boston regarding New England Compounding Pharmacy. There's disturbing news on a relapse.

 One of the victims of last year's deadly outbreak of fungal meningitis has suffered a relapse. Rebecca Climer, spokeswoman for Nashville's Saint Thomas West Hospital, wrote in an email that a patient was admitted on Thursday after suffering a re-occurrence of the sometimes-deadly infectioThe hospital reported the relapse to the Tennessee Department of Health. It also is contacting other fungal meningitis patients   to alert them to be on the lookout for possible symptoms of a relapse. 

  The relapse was first reported in The Tennessean newspaper.

Meningitis is an inflammation of the lining of the spinal cord and brain that is usually caused by a bacteria or virus. Fungal meningitis is extremely rare, and last year's outbreak is blamed on injectable steroids that were contaminated with mold from the now-closed New England Compounding Center in Massachusetts.
Because the disease is so rare, health officials have called the treatment "new territory" and said there are no studies to advise how long patients should be kept on the powerful antifungal drugs that come with several nasty side effects.

Wednesday, October 02, 2013

Shutdown curbs CDC's ability to fight disease, FDA's ability to Inspect

I'm one of those people that politicians and parties usually want to court- I vote person, not party. Years ago I worked on Bob Dole's presidential campaign on the GOP side. I worked on the Lawton Chiles campaign for Governor in Florida (Chiles was a Dem).The government shutdown is on all national politicians. Shame on each of them. Here are two headlines that should be enough for those idiots in Washington to sit down today and get to work.

Shutdown curbs CDC's ability to fight disease

The Centers for Disease Control headquarters in Atlanta felt deserted. Two thirds of the center's 13,000 employees worldwide have been furloughed, and its director, Dr. Thomas Frieden, is worried.

"I usually don't lose sleep despite the many threats we face, but I am losing sleep because we don't know that we will be able to find and stop things that might kill people," he said.

The shutdown means the CDC will not be able to produce the weekly national map that tracks flu outbreaks state by state. Flu season began last month.


 FDA Food Safety Inspections Suspended During Government Shutdown

The FDA oversees the safety of the vast majority of the country's food industry. And according to a memo released by the Department of Health and Human Services, the bulk of FDA food inspectors have been deemed non-essential, so will inspect few if any food facilities until Congress and the president agree on a bill to fund the federal government.


If one person dies because of this, each and every member of congress will be responsible.