Hardmenstore.com Recalls 72HP, Evil Root and Pro Power Ma

From the FDA:

Hardmenstore.com is recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED).

Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

These products are intended to be used as a dietary supplement and sexual supplement. 72HP is packaged in a single blister pack containing 1 dose. Evil Root is packaged in box containing a bottle of 6 pills. Pro Power Max is packaged in a single blister pack containing 1 dose.

All lots of 72HP, Evil Root and Pro Power Max are included in this recall. 72HP can be identified by the yellow packaging with a black horse insignia. Evil Root can be identified by its orange box with blue Chinese characters. Pro Power Max can be identified by the black and red packaging with flames on the bottom of the packaging. These sealed and packaged products were delivered to Hardmenstore.com as having contained only legitimate and lawful ingredients.

Aided with the information provided by the FDA, Hardmenstore.com is now notifying its distributors and customers by an email and online notice on the homepage of our site. It is arranging for a return of all recalled products. Consumers and retailers that have the 72HP, Evil Root or Pro Power Max supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.

http://www.fda.gov/Safety/Recalls/ucm366506.htm

Cubist Pharmaceuticals Recall of Four Lots of Cubicin

From the FDA:

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced it is voluntarily recalling four lots of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots.

Product Description	Lot #	Expiration Date	First Ship Date	Last Ship Date
CUBICIN® (daptomycin for injection) 500 mg NDC 67919-011-01	950453F	12/06/2013	05/31/2011	06/27/2011
	090203F	09/07/2014	01/12/2012	01/23/2012
	201703F	08/31/2015	03/4/2013	03/7/2013
	201653F	09/01/2015	03/12/2013	03/18/2013

No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.

Cubist is notifying customers by letter and phone. Anyone with an existing inventory of the product lots listed should determine whether they have product from the recalled lots, quarantine and discontinue distribution of all recalled lots of the product and call Cubist at (855) 534-8309 between the hours of 9 a.m. to 7 p.m. EST, Monday through Friday, to arrange for return and replacement of affected lots.

The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious.

As noted in the package insert for CUBICIN, parenteral drug products should be carefully inspected visually for particulate matter prior to administration. Healthcare providers should not use any CUBICIN vials containing particulate matter.

FDA Issues Warning on Gilenya, Citing Potential Risk of Dangerous Brain Disease

News about Gilenya is making the rounds.

Gilenya was approved in the US in 2010 for the treatment of a relapsing form of MS, and is currently used by approximately 70,000 patients. Gilenya has been subject to reports of new safety risks since its approval. In May 2012, FDA issued a safety warning and instituted new contraindications for Gilenya after it investigated reports that several patients had died soon after taking the drug.

From the FDA site: 

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod).  The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.  FDA could not definitively conclude that Gilenya was related to any of the deaths (see Data Summary, below). However, based on its reevaluation of the data, FDA remains concerned about the cardiovascular effects of Gilenya after the first dose. Data show that, although the maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients

The FDA also said it recommends cardiovascular monitoring be extended past six hours after the first dose for patients “who are at higher risk for or who may not tolerate” a slowdown in the rate at which their heart beats (bradycardia).

Now, on August 29th, this news:

 The U.S. Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod). This is the first case of this disease, called progressive multifocal leukoencephalopathy or PML, reported following the administration of Gilenya to a patient who had not previously received Tysabri (natalizumab), an MS drug associated with a higher risk of PML.

Patients should not stop taking Gilenya without first discussing any questions or concerns with their health care professionals. We are providing this alert while we continue to investigate the PML case, and we are working with Gilenya’s manufacturer, Novartis, to obtain and review all available information about this occurrence. We will communicate our final conclusions and recommendations after our evaluation is complete.

PML is a rare and serious brain infection caused by the John Cunningham (JC) virus that damages the fatty covering of the brain called myelin. Myelin is essential for the proper functioning of nerves in the white matter of the brain. PML usually causes death or severe disability. The JC virus is a common virus that is harmless in most people but can cause PML in people who have weakened immune systems. Some medications, including Gilenya, can weaken the immune system.

Gilenya is used to treat relapsing forms of MS, a nervous system disease that affects the brain and spinal cord. MS is thought to affect more than 2 million people worldwide. The drug was approved for use in the United States in September 2010. Novartis reports that approximately 71,000 patients worldwide have been treated with Gilenya.

The patient who developed PML received nearly eight months of Gilenya treatment before being diagnosed with PML. The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. The patient also received multiple courses of intravenous corticosteroids for several months before and during Gilenya treatment. The diagnosis was made based on clinical symptoms and the detection of JC viral DNA in the cerebrospinal fluid. Gilenya treatment was stopped.

Read more here http://www.raps.org/focus-online/news/news-article-view/article/4004/fda-issues-warning-on-gilenya-citing-potential-risk-of-dangerous-brain-disease.aspx

New case: Prejudice is Presumed When ESI Destruction is Willful

An interesting read from last week: Sekisui America Corp. was sanctioned for deleting the emails of the former president of a merger target whom it is suing for breach of contract. One of the disputes at issue is whether sanctions were warranted against the plaintiff company for deleting a defendant’s email folder. The fact that the email folder was destroyed was undisputed, but plaintiff claimed it was an innocent mistake to free up space on the server. Defendants sought sanctions.

Here's the case: 

081913scheindlin from mzamoralaw

In the Court’s order regarding an adverse inference instruction, Judge Scheindlin found as a matter of law that the destruction took place after the duty arose, but left as a question of fact for the jury to decide whether to presume the evidence was favorable to the Harts

New England Compounding Center Litigation Update: Mediation Order Entered 8/15/13

I serve as counsel on the Plaintiffs' Steering Committee in this litigation, currently based in Boston, Massachusetts before Judge Saylor. After submissions, the Court entered an Order on August 15, 2013, which is here:

 

Mediation Order New England Compounding Pharmacy from mzamoralaw

August News Retinopathy of Prematurity

Lawyer Richard Shapiro investigates cases involving this tragic medical condition. 

During development, blood vessels grow from the central part of the retina outwards. This process is completed a few weeks before the normal time of delivery. However, in premature babies it is incomplete. If blood vessels grow normally, ROP does not occur. If the vessels grow and branch abnormally the baby develops ROP. That may lead to bleeding inside the eye. When the blood gets resolved, it may give rise to band like membranes which may pull up the retina, causing detachment of retina and eventually blindness before 6 months.

Normally, maturation of the retina proceeds in-utero, and at term, the medial portion of the retina is fully vascularized, while the lateral portion is only incompletely vascularized. If a pre-term infant is treated with oxygen, the oxygen may cause constriction of the retinal blood vessels. This vasoconstriction can lead to a lack of oxygen (ischemia) in the retina. This leads to the production of molecules that cause the growth of new blood vessels (VEGF). These blood vessels are abnormal, and negatively affect the normal development of retinal vasculature. Thus, retinopathy of prematurity occurs when the normal development of retinal blood vessels is prevented.

The key disease element in ROP is fibrovascular proliferation. This is growth of abnormal new vessels that may regress, but frequently progress. Associated with the growth of these new vessels is fibrous tissue (scar tissue) that may contract to cause retinal detachment. Multiple factors can determine whether the disease progresses, including overall health, birth weight, the stage of ROP at initial diagnosis, and the presence or absence of "plus disease". Supplemental oxygen exposure, while a risk factor, is not the main risk factor for development of this disease

Read more about this condition at   http://babyblindness.com/medical-wrongdoing/

New Yorkers Warned about Dietary Supplements Healthy Life Chemistry By Purity First B-50, Multi-Minerals

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

 The New York State Department of Health on Wednesday announced that consumers should not use or purchase Healthy Life Chemistry By Purity First B-50, Multi-Minerals, or Vitamin C marketed as dietary supplements, due to the possible presence of potentially harmful anabolic steroids.

The New York State Department of Health on Wednesday announced that consumers should not use or purchase Healthy Life Chemistry By Purity First B-50, Multi-Minerals, or Vitamin C marketed as dietary supplements, due to the possible presence of potentially harmful anabolic steroids.

The U.S. Food and Drug Administration and DOH have received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50. Some of these patients were reported to have also taken Healthy Life Chemistry By Purity First Multi-Mineral and/or Vitamin C. These reports include fatigue, muscle cramping, and muscle pain, as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. In addition, according to the FDA, females who used these products reported unusual hair growth and missed menstruation, and males who used the products reported impotence and findings of low testosterone.

The Department of Health issued advisories to the health provider community and is working with providers to help characterize symptoms and make recommendations for management of the health effects of use of the product. DOH is providing its support and cooperation, as needed, to assist the FDA's investigation into this matter. 

Preliminary testing by the FDA of the Healthy Life Chemistry By Purity First B-50 product demonstrated the presence of anabolic steroids including methasterone and dimethazine. These ingredients are not listed on the label and should not be in a dietary supplement, the FDA reported. According to Purity First Health Products, Inc, the Multi-Mineral and Vitamin C capsules appear to contain dimethyltestosterone.

http://www.wbng.com/news/state/State-Health-Department-warns-New-Yorkers-about-harmful-dietary-supplements-218717021.html

Litigating When You Don't Do Your Homework

Today's blog entry is courtesy of a recent report that a person in California sued New England Compounding Center/Pharmacy, alleging injuries from a contaminated product. That company is known across the USA as NECC.

Problems? Well, the first one is this - The lawyers for the Plaintiff in that case named a bankrupt company. Those same lawyers served the Complaint not on NECC's agent, but on a Plaintiff's law firm in Nashville that represents injured consumers in lawsuits against NECC.

Problem number two - The very same lawyers who served the wrong company then moved for Default.

Problem number three: NECC is bankrupt, and had there been even a basic Google.com search done, any person would have known that. In the Removal papers, there is this statement by counsel:

Even if Plaintiff had attempted to serve an appropriate agent for NECC, service of process could not be completed as a result of the bankruptcy stay, and therefore NECC believes that this Notice has been filed within the time period set forth in Federal Rules of Bankruptcy Procedure ("Bankruptcy Rules") 9027(a)(3). 

The State Court Action was purportedly commenced after the Bankruptcy  Proceeding, and no order for relief has been entered in the Bankruptcy Proceeding, nor has any order been entered terminating the automatic stay imposed under 11 U.S.C. § 362(a). 

The Plaintiffs' lawyers in that case are about to learn some potentially painful lessons. As noted in the Removal papers:  NECC reserves all rights including, but not limited to, any and all defenses available to it for violations of the automatic stay pursuant to 11 U.S.C. §362(a).

This is a cautionary tale about sloppiness and the failure to conduct due diligence on a national litigation before filing a case. Had counsel taken a few moments to review pleadings, they would have seen that there are multiple defendants in other cases, and those should have been named.

A related article is here: http://www.tennessean.com/article/20130805/NEWS07/308050052/Meningitis-outbreak-California-patient-files-suit

Here are the removal papers:

Necc removal from mzamoralaw

Stay tuned.

8/8/13 Alert: Specialty Compounding Sterile Products, Texas : FDA Alert - Bacterial Infections

More bad news in the compounding industry. Our office is investigating the industry, and we currently serve as one of seven national counsel for consumers in the NECC litigation:

Bacterial infections have been potentially associated with contaminated calcium gluconate infusions produced by Specialty Compounding, Cedar Park, TX.

FDA has received reports of 15 adverse events experienced by patients in two hospitals. The 15 patients received an infusion of calcium gluconate 2 grams in Sodium Chloride 0.9% for Injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. These infections are thought to be related to the infusions. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show growth of bacteria that are consistent with Rhodococcus species.

BACKGROUND: Calcium gluconate by infusion can be used to treat conditions associated with low calcium levels in certain circumstances.

RECOMMENDATION: FDA is alerting health care professionals not to use any sterile products supplied by Specialty Compounding, Cedar Park, TX.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

404-451-7781.

Or use the contact form. 

The BP Settlement: How the Lawyers See Their Role

From the NYT:

To the Editor:

Re “Lawyers’ Business Model,” by Joe Nocera (column, July 30)

When corporations act irresponsibly by producing unsafe products, polluting our environment or swindling their employees and shareholders, often the only place for Americans to hold them accountable is in our courts. The civil justice system provides a key incentive for corporations to prioritize safety from the start.

In yet another column attacking trial lawyers in order to defend BP, Joe Nocera disregards the important role that the civil justice system plays in our society.

As the president of the American Association for Justice, I know firsthand how hard our members are working to make sure that Americans can get justice in the courtroom, even when it means taking on the most powerful interests. I also know from my own clients how essential it is to have a strong civil justice system that enables Americans to hold wrongdoers accountable.

When businesses in the Gulf sought to hold BP accountable for the devastating effects of the oil spill, BP’s team of corporate lawyers co-authored, agreed to and sought court approval of the very settlement that Mr. Nocera finds offensive. BP may have underestimated the financial damage it caused, but trial lawyers are not to blame for that. That blame still remains with BP.

Instead of pitying BP and corporations like it, let’s focus on fixing the root of the problem: the dangerous products, negligence and corporate wrongdoings that harm Americans.

BURTON LeBLANC
Washington, July 31, 2013

Salon, Lazy Writing, and New Orleans

For those who read this blog, you see that I tend to write about non law subjects like my love of New Orleans, dogs, and football. Today this post is about New Orleans, and how some lazy writer throws out the "fate" of that city in a way that to me suggests he's an idiot, and also suggests how low the bar now is when it comes to supposed journalism.

The title of the  article is:  

Why the right hates Detroit 

How the fates of two great cities, Detroit and New Orleans, symbolize what's gone wrong with America.

http://www.salon.com/2013/07/27/why_the_right_hates_detroit/

  
What brings up the bile for me is this comment in the Salon writer's piece: "Is it pure coincidence that these two landmark cities, known around the world as fountainheads of the most vibrant and creative aspects of American culture, have become our two direst examples of urban failure and collapse?"


Ah yes. The rise of the 'journalists' who never leave the comfort of their own desks before spouting off at the keyboard. Because had this write done so, he would KNOW -- just from a two day trip -- that while the post Katrina recovery in the past 7-8 years has had its share of tragedy, despair, and frustration, New Orleans today has more than 1100 new restaurants than its' Pre-Katrina calamity. Or that neighborhoods have been rebuilt better, smarter, and safer. Or that musicians have their own new homes. Or that summer festivals like Satchmo fill the streets, and that White Linen night has folks voluntarily walking in the August sun and heat. Or that the Essence Music Festival - held in New Orleans in July for crying out loud - is one of the most important "be seen" events in the music industry. 


Had this lazy piece of crap writer taken a trip to New Orleans, he'd know that Mayor Mitch has done many things in advance of a Super Bowl. Improvement to sidewalks, streets, and trollies. He have known all that. Way back in the 20th century writers used to do that type of research.  Maybe he did take a trip, and forgot to write about it in his piece. But  he didn't visit the city, because he had done so he would have found information first hand not found on page one of Google or on Nola.com.  

Is a  picture worth a thousand words? You bet. Detroit's shot with the piece was this:

Detroit - this year    

Now, a simple phone call or email would have yielded information on New Orleans that would have shown that - horrors! While it takes time to rebuild, it's not a generational purgatory of restoration. Here's a photograph that captures the polar opposite of what NOLA and the Motor City have become:

New Orleans, this August

What the writer completely misses is that post calamity there's this quirkly little thing called the human spirit that seems to take over. Not government. Hell, government's lesson in Katrina was made clear - you are on your own. It's stay out of the way and let the people do it. It's that people make the city - people opening bars and hotel like the Saint. People opening pop up kitchens and restaurants. Lawyers groups like AAJ deciding to come to New Orleans for a meeting,  where 2,000+ people will party and have a good time. It's the Edge, Brad Pitt and others building homes for residents. 

The next time some writer decides to compare New Orleans to any city in America, some 'lawyerly" advice before doing so: Walk the land first.   Katrina will always be a part of the history of New Orleans, as opposed to the present.  I know this sounds crazy, but leave the comfort of your office of loft. Endure the bugs.   

The real shame of the article? It's not the message that right is to blame - whatever the "right" political boogey man might look like - or that the right that hates a city. It's what a city is or might be able to do with itself after it hits rock bottom. I don't mean financial rock bottom, I mean hundeds of lives lost, elderly drowning in nursing homes, animal carcasses floating in the street, whole neighborhoods obliterated rock bottom. 

Come see me during Mardi Gras, Salon writer.  New Orleans made it back. Could Detroit? 

    
     

Volcano Male Enhancement Liquid and Capsules Recall

Volcano Company is voluntarily recalling all lots of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules to the consumer level. FDA test results revealed the Volcano Male Enhancement Liquid has been found to contain undeclared Desmethyl Carbodenafil, Dimethylsildenafil, and Dapoxetine. FDA test results revealed Volcano Capsules have been found to contain undeclared Desmethyl Carbodenafil and Dapoxetine. 

Desmethyl Carbodenafil and Dimethylsilsildenafil are Phosphodiesterase (PDE) 5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA).

http://www.infozine.com/news/stories/op/storiesView/sid/56537/

Company recalls faulty glucose test strips (Nova Max)

 Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.

The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the recalled lots and catalog numbers.

A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.

http://www.novacares.com/news/nova-max-recall.php

Recall of 8 whitening products with substance causing uneven skin color

FDA enforcement spans the globe. Here's news from the Phillipines:

Health authorities on Friday recalled at least eight skin-whitening products containing Rhododenol, which is suspected of causing white blotches and uneven skin color.

In an advisory posted on its website, the Food and Drug Administration said the products involved belong to Kanebo Cosmetics Inc., and had been voluntarily recalled in other Asian markets.

"(T)he Philippine FDA hereby recalls all products that were issued market authorization and to ban other products manufactured by Kanebo that contain Rhododenol, a substance contained in the skin-whitening or brightening products that was developed by Kanebo and have been reported or implicated to cause white blotches and uneven coloring of the skin," it said.
http://www.gmanetwork.com/news/story/316132/news/nation/fda-recalls-8-whitening-products-with-substance-causing-uneven-skin-color

FDA warns of vitamin B supplement contains dangerous steroids- Healthy Life Chemistry By Purity First B-50

Today, the U.S. Food and Drug Administration is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.

“Products marketed as a vitamin but which contain undisclosed steroids pose a real danger to consumers and are illegal,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as vitamins and dietary supplements do not pose harm to consumers.”

The FDA has received reports of 29 adverse incidents associated with the use of Healthy Life Chemistry By Purity First B-50.  These reports include fatigue, muscle cramping, and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels.

Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone. Consumers using Healthy Life Chemistry By Purity First B-50 who experience any of these symptoms should consult a health care professional and report their experience to the FDA.

Using anabolic steroid-containing products may cause acute liver injury. Some of the cases reported have resulted in hospitalization, but there were no reports of death or acute liver failure.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm362799.htm

Use Sunscreen Spray? Avoid Open Flame

The next time you are lighting a cigar on the beach with a large flamed lighter, remember this from the FDA:

The Food and Drug Administration (FDA) has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment. The specific products reported to have been used in these cases werevoluntarily recalled from the market, so should no longer be on store shelves.

However, many other sunscreen spray products contain flammable ingredients, commonly alcohol. The same is true for certain other spray products, such as hairspray and insect repellants, and even some non-spray sunscreens may contain flammable ingredients. Many flammable products have a label warning against their use near an open flame.

You should never apply a product labeled as flammable while you are near a source of flame. In the five incidents reported to FDA, however, the burns occurred after the sunscreen spray had been applied. The ignition sources were varied and involved lighting a cigarette, standing too close to a lit citronella candle, approaching a grill, and in one case, doing some welding. These incidents suggest that there is a possibility of catching fire if you are near an open flame or a spark after spraying on a flammable sunscreen—even if you believe you have waited a sufficient time for the sunscreen to dry and your skin feels dry.

"Based on this information, we recommend that after you have applied a sunscreen spray labeled as flammable, you consider avoiding being near an open flame, sparks or an ignition source," says Narayan Nair, M.D., a lead medical officer at FDA.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm359437.htm

FDA: Investigating two deaths after injection of Zyprexa Relprevv

The U.S. Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).  The patients died 3-4 days after receiving an appropriate dose of the drug, well after the 3-hour post-injection monitoring period required under the Zyprexa Relprevv Risk Evaluation and Mitigation Strategy (REMS).  Both patients were found to have very high olanzapine blood levels after death. High doses of olanzapine can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma.

FDA is providing this information to health care professionals while it continues its investigation.  If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations.  Patients and caregivers should talk to their health care professional(s) about any questions or concerns.

Under the REMS, patients are required to receive the Zyprexa Relprevv injection at a REMS-certified health care facility, to be continuously monitored at the facility for at least 3 hours following an injection, and to be accompanied home from the facility.  The Zyprexa Relprevv label contains warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium.  In the clinical trials supporting the approval of Zyprexa Relprevv, cases of PDSS were observed within 3 hours after administration of Zyprexa Relprevv, but there were no deaths due to PDSS.  These two patients died 3-4 days after receiving an appropriate dose of the drug, and it is not clear whether they died from PDSS.

http://www.fda.gov/Drugs/DrugSafety/ucm356971.htm

FDA approves label changes for Olmesartan

The U.S. Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.  FDA has approved changes to the labels of these drugs to include this concern.

Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization (see Data Summary). If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients.

Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs.  Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.

http://www.fda.gov/Drugs/DrugSafety/ucm359477.htm

EvaPharmacy FDA Warning Letter

Here's a June 2013 warning letter:

The United States Food and Drug Administration (FDA) recently reviewed your websites (listed in the table located at the bottom of this letter and in the attachment)[1] and has determined that your websites offer products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the websites listed below offer unapproved and misbranded new drugs for sale in violation of sections 301(a), 301(d), 502(f), 503(b)(1), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 352(f), 353(b)(1), 355(a)]. We request that you immediately cease marketing violative drug products to United States consumers.

 

Unapproved New Drugs

 

As labeled, certain products you offer for sale through your websites are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These products, as marketed through your websites, are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Based upon our information, no approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for these products.  Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 355(a) and 331(d)].

 

As two examples, your firm offers for sale through your websites “Levitra Super Force” and “Viagra Super Force,” which contain the brand names of FDA-approved drugs ( “Levitra” and “Viagra”). Your websites claim that Levitra Super Force and Viagra Super Force are “for the treatment of male impotence and premature ejaculation” and “for the treatment of male sexual problems,” respectively, both of which are intended uses to treat disease and, as such, are subject to section 505 of the FD&C Act [21 U.S.C. § 355]. In addition, Levitra Super Force and Viagra Super Force include dapoxetine, an active ingredient that is not the subject of an FDA-approved application. These two drugs your firm offers for sale without approved applications are in violation of section 505 of the FD&C Act [21 U.S.C. § 355]. Accordingly, their introduction or delivery for introduction into interstate commerce violates section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm358809.htm

BP Starts a Campaign Against Lawyers - Places Ads in National Papers

You may have heard about the BP newspaper ads. Yes, some people still read papers. Here is what Americans should know as well about BP:

BP is not a victim of small businesses, judges or even trial lawyers; they are still just a corporate felon who pled guilty to killing 11 rig workers, polluted the Gulf and ruined the livelihoods of thousands of Americans.

Here are the facts:

• BP pled guilty to 11 counts of manslaughter and lying to the Federal Government, stemming from the Deepwater Horizon tragedy.
• BP was on probation for three prior disasters at the time of the blowout.
• BP has been suspended from doing business with the US government for a lack of corporate integrity.
• For nearly two years BP’s team of corporate lawyers negotiated, co-authored, agreed to, and sought Court approval of every word in the Settlement Agreement resulting from the oil spill disaster.