Friday, February 27, 2015

Walgreens, Walmart, GNC and Target Pull Dietary Supplements from Shelves

Four large retailers were ordered  by the New York State Attorney General’s Office to immediately stop selling their store brands of herbal dietary supplements due to allegedly mislabeled or adulterated product content.
Attorney General Eric T. Schneiderman and Executive Deputy Attorney General Martin J. Mack issued cease-and-desist orders to GNC Holdings, Inc., Target Corporation, Walgreens, Wal-Mart Stores, Inc., regarding the marketing of up to seven herbal supplements: Gingko [sic] biloba, St. John’s Wort, Ginseng, Garlic, Echinacea, Saw Palmetto, and Valerian root. (Valerian was only tested from Target, in place of Ginseng.).

Tuesday, February 24, 2015

Zofran Making the News- A Timeline (as of February 2015)

In recent months, our law firm have been investigating the link between Zofran taken for morning sickness during the first trimester of pregnancy and serious fetal injuries involving this product. 
Call us anytime, or email me directly - mark(at)    (You can also read more at
What is it? Ondansetron (INN), originally marketed under the brand name Zofran, is a serotonin 5-HT3 receptor antagonist used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. For some women, it was used to treat nausea. 
We believe there is now evidence that Zofran may allegedly  be the cause of defects in children. The FDA never approved this drug for morning sickness and GlaxoSmithKline (GSK), the maker of this drug, paid a $2 billion settlement in a civil lawsuit that involved allegations that GSK illegally promoted its Zofran drug to be prescribed to expectant mothers.  This settlement did not include payments for injuries suffered due to the use of Zofran. 
Here is a timeline of this product: 
January 5, 1993:  The New York Times reported that the FDA approved a pill form of Zofran.

January 4, 1991:  The FDA approved Zofran (ondansetron) for chemotherapy-related nausea and vomiting 

June 22, 1995:  GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride)

June 24, 1997:  The FDA approved GlaxoWellcome's New Drug Application (see June 22, 1995, entry).

March 9, 1999:  The FDA issued a warning letter to GlaxoWellcome regarding its marketing of anti-nausea drug Zofran. According to that letter, Glaxo failed to warn consumers about Zofran's adverse side effects while touting its effectiveness with statements such as:
·         "Zofran can,"
·         "24-hour control," and
·         "Prevention of emesis I to 2 days after chemotherapy."

June 22, 1995:  GlaxoWellcome submited a New Drug Application to the FDA for a 4mg/5mL dose of Zofran (ondansetron hydrochloride) 

June 24, 1997:  The FDA approved GlaxoWellcome's New Drug Application 
December 27, 2006:  The FDA approved generic versions of Zofran .
August 2011:  To test Zofran's cardiac risks, GlaxoSmithKline began a study titled "A Randomized, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous Ondansetron, a 5-HT3 Antagonist, on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects" 
September 2011: GlaxoSmithKline revised Zofran labels to include the following, per the FDA:
  • "Information regarding post-marketing case reports of Torsade de Pointes;
  • Recommendation to avoid use in patients with known congenital long QT syndrome;
  • ECG monitoring recommendation in patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation."
September 15, 2011:  The FDA issued a Drug Safety Communication regarding Zofran  That alert stated that:
  • Zofran may change the heart's electrical activity and that change could cause an abnormal heart rhythm such as Torsade de Pointes; and
  • Zofran's labels would therefore be revised. Per the FDA:
The labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Additionally, recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation.
The FDA also ordered Zofran maker GlaxoSmithKline to conduct QT prolongation studies.
January 2012:The CDC’s Nation Center on Birth Defects and Developmental Disabilities publishes a report finding that Zofran (ondansetron) taken during the first trimester of pregnancy doubles the risk of a cleft palate birth defect.

There were over 9,000 pregnant women in the study overall, both cases and controls; 67% reported NVP and 15% used some kind of agent to treat NVP. The study used data from the National Birth Defects Prevention Study, looking at the association between NVP and treatments for NVP and cleft palate, and other noncardiac birth defects. Link here

June 2012: GlaxoSmithKline (GSK), the maker of Zofran, pleads guilty to federal criminal health care fraud charges for violations of the Food, Drug, and Cosmetic Act relating to three of its branded drugs. At the same time, GSK also agrees to pay $1 billion in criminal penalties as well as $2 billion in civil penalties to resolve a federal whistleblower lawsuit that included claims that GSK wrongfully promoted Zofran for off-label promotion for use in expectant mothers, and paying kickbacks to doctors to prescribe Zofran for such off-label use.
This $3 billion dollar penalty is the largest combined federal and state health care fraud recovery in a single global resolution in the history of the United States. 
August 2013: Two papers relating to Zofran and birth defects are presented at the International Society of Parmacoepidemiology. The first paper concludes that Zofran (ondansetron) taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. Importantly, the second paper includes the data from the first paper but covered more years and more pregnant woman that the first study and came to an opposite conclusion: There is a doubling of the risk of cardiac malformations. Specifically, there was a significant increase in the prevalence of major congenital heart defects in children whose mothers redeemed a presdription of Zofran (ondansetron) during in the first trimester of pregnancy. 
August 2013: Two papers relating to Zofran and birth defects are presented at the International Society of Parmacoepidemiology. The first paper concludes that Zofran (ondansetron) taken during pregnancy was not associated with a significantly increased risk of adverse fetal outcomes. Importantly, the second paper includes the data from the first paper but covered more years and more pregnant woman that the first study and came to an opposite conclusion: There is a doubling of the risk of cardiac malformations. Specifically, there was a significant increase in the prevalence of major congenital heart defects in children whose mothers redeemed a presdription of Zofran (ondansetron) during in the first trimester of pregnancy. 
July 2014: American researchers confirm earlier reports that Zofran (ondansetron) crosses the placental barrier during pregnancy in relatively high concentrations (approximately 40% of the maternal plasma levels) after just three oral doses. The authors conclude that the high lipid solubility of Zofran (ondansetron) increases its ability to be taken up into fetal tissue in larger amounts. 

August 2014: A Swedish study investigating the risk of birth defects from Zofran (ondansetron) reports that this drug poses a significantly increased risk for cardiac septum defects in the offspring of women who took Zofran during the first trimester of pregnancy. 

From the FDA in 2013:

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January– March 2013

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2013 in the FAERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) January - March 2013

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of March 1, 2014)

Metoprolol succinate extended release products
Lack of therapeutic effect, possibly related to product quality issues

FDA decided that no action is necessary at this time based on available information.
Serotonin-3 (5-HT3) receptor antagonist products (Aloxi, Kytril, Zofran, Zuplenz)
Serotonin syndrome
FDA is continuing to evaluate this issue to determine the need for any regulatory action.

Thursday, February 05, 2015

A.G. Schneiderman Asks Major Retailers To Halt Sales Of Certain Herbal Supplements As DNA Tests Fail To Detect Plant Materials Listed On Majority Of Products Tested

N.Y. Attorney General Eric T. Schneiderman announced that his office sent letters to four major retailers, GNC, Target, Walmart, and Walgreens, for allegedly selling store brand herbal supplement products in New York that either could not be verified to contain the labeled substance, or which were found to contain ingredients not listed on the labels. The letters, sent Monday, call for the retailers to immediately stop the sale of certain popular products, including Echinacea, Ginseng, St. John’s Wort, and others. Attorney General Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place.
The letters come as DNA testing, performed as part of an ongoing investigation by the Attorney General’s Office, allegedly shows that, overall, just 21% of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels — with 79% coming up empty for DNA related to the labeled content or verifying contamination with other plant material. The retailer with the poorest showing for DNA matching products listed on the label was Walmart. Only 4% of the Walmart products tested showed DNA from the plants listed on the products’ labels.
“This investigation makes one thing abundantly clear: the old adage ‘buyer beware’ may be especially true for consumers of herbal supplements,” said Attorney General Schneiderman. "The DNA test results seem to confirm long-standing questions about the herbal supplement industry. Mislabeling, contamination, and false advertising are illegal. They also pose unacceptable risks to New York families—especially those with allergies to hidden ingredients. At the end of the day, American corporations must step up to the plate and ensure that their customers are getting what they pay for, especially when it involves promises of good health.”

Tuesday, February 03, 2015

Xarelto Litigation Goes to Judge Fallon in New Orleans

Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgeryXarelto is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Xarelto lawsuits continue to be filed on behalf of people who suffered serious bleeds as a result of taking Xarelto. In light of how many lawsuits have been filed, the Judicial Panel on Multidistrict Litigation (JPML) elected to coordinate the litigation in front of a single federal judge. The JPML transferred the Xarelto litigation to Judge Eldon E. Fallon of the Eastern District of Louisiana.
Judge Fallon is a well-respected judge who has extensive experience handling large scale products liability litigation. Over the next several months, Judge Fallon will get orders in place appointing Plaintiff's counsel leadership and determining issues affecting confidentiality, document production, scheduling, and discovery among other issues. It is expected that the Xarelto litigation (entitled In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592) will continue to grow exponentially with more cases being filed every month.

Friday, January 23, 2015

Plaintiff must product 1200+ photographs from FB- Nucci v. Target and what it means

In Nucci v. Target,  a Florida appellate court ordered a plaintiff to produce photographs from her personal Facebook page.  In this personal injury action, in which the plaintiff claims to have fallen at defendant’s store, the court ruled that “[t]he photographs sought were reasonably calculated to lead to the discovery of admissible evidence and Nucci’s privacy interest in them was minimal, if any. Here is the case. Below it, some thoughts:

What to do? Well, a lawyer should realize that from now on this case is the standard bearer for discovery in the FB setting. Self surveillance is here to stay. In my view, date from a FB page will be no different than an MRI report in cases in the near future.  

How to address? 

1. Have your client inventory all photographs on Facebook. While a photo of a client running may go to the claim of  injury, how would (for example) a client sitting in church be relevant? 

2. Expect to product some information. Offer it up, because if you do not, a Court will. 

3. Never give out a password, or allow your client to let defense counsel "friend" him/her. 

Friday, December 19, 2014

Caramel Apples Recall (Listeria)

U.S. and state health officials are investigating a Listeria outbreak linked to caramel apples that has killed at least four people and sickened 28 others in 10 states.
Consumers should not eat any commercially produced, prepackaged caramel apples until more information becomes available, the U.S. Centers for Disease Control and Prevention said in a news release.
As of Dec. 18, a total of 28 people had been infected with the outbreak strains of the bacteria Listeria monocytogenes. Of the 26 people who have been hospitalized, five have died. Listeria infections contributed to at least four of those deaths, the agency said.
Nine illnesses occurred in pregnant women or newborn infants, and there have been three cases of invasive illness (meningitis) among otherwise healthy children aged 5 to 15, the CDC said.
Symptoms of listeria infection include fever, chills, headache, upset stomach and vomiting. Antibiotics are typically used to treat the infection.
Of the 18 ill people interviewed so far, 15 said they ate commercially produced, prepackaged caramel apples before becoming sick. To date, no illnesses have been linked to apples that are not caramel-coated and prepackaged, or to caramel candy.
Although caramel apples are usually sold in the fall, the CDC said they may still be for sale in stores or may be in consumers' homes.
Investigators are trying to identify specific brands of caramel apples that may be linked to the outbreak, and to pinpoint the source of contamination, the CDC said.

Wednesday, November 19, 2014

Solgar Inc. Recalls Dietary Supplement

The product, ABC Dophilus Powder, was found to contain the fungus rhizopus oryzae, which is linked to the infection mucormycosis. The federal Centers for Disease Control tested the powder after the October death of a preterm infant who had been given ABC Dophilus in a hospital. The baby, who had been born at 29 weeks, suffered from multiple complications, including intestinal mucormycosis, according to Solgar.

Andrea Staub, a spokeswoman for Solgar, said  that the company and the Food and Drug Administration are still investigating whether there was any connection between the product and the baby's death. She declined to give the name or location of the hospital where the death occurred.

The company initiated the recall "out of an abundance of caution," Staub said.
She said the recall involves fewer than 2,000 bottles, which were made by a subcontractor she declined to identify.

Rhizopus oryzae is found in soil and can cause mucormycosis, especially in people with diabetes, cancer, skin trauma or compromised immune systems. Otherwise healthy people can also catch the infection, though rarely, according to the FDA.
ABC Dophilus Powder is a supplement for infants and children containing "friendly" bacteria to aid in digestive health.

Friday, November 07, 2014

AMP Citrate Ingredient Causes Concerns

From USA Today:

News reports are mentioning AMP citrate, which some consider to be a close cousin of DMAA. AMP citrate is sometimes referred to as methylpentanamine.  Scientists in the United States and the Netherlands testing several products found that the amount of the new synthetic stimulant varies widely, the dosage isn't disclosed on labels, there isn't much evidence that the chemical is natural and none that it's safe in humans. 

Read more here:

Supplements safe after FDA recall? Don't count on it

This article from the Los Angeles Times is worth a read:

 Several months after supplements were recalled for being illegally laced with prescription drugs, researchers bought them off the shelves and from the online inventories of supplement retailers and checked whether they continued to contain the illegal substances for which they'd been recalled.In two-thirds of cases, the supplements did. 

Link here:

FDA Finally Takes Bab Steps on Supplement Weight Loss Claims

I'm not a fan of the woefully understaffed, underfunded FDA. In spite of the business sector's overwhelming fiscal might, there are signs of hope. This story is one sign.  

The Food and Drug Administration is moving forward with new proposals to the manufacturers of dietary supplements that have drawn a closer look because of claims of  miracle weight loss.
The FDA already prohibits pharmaceutical companies from making misleading claims about their dietary supplements. To help manufacturers comply with these rules, the agency has issued voluntary guidelines for companies making dietary supplement claims.
The guidelines show what evidence companies will need to back up their dietary supplement's "general well-being claims." This could include articles published in peer-reviewed scientific journals, for example.
"It is unlikely that a dietary supplement manufacturer will attempt to make a claim when the cost of obtaining the evidence to support the claim outweighs the benefits of having the claim on the product’s label," the FDA wrote in the Federal Register.
Find this report:   Agency Information Collection Activities; Proposed Collection; Comment Request; 
Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and 
Cosmetic Act here

Tuesday, October 28, 2014

10 Brands of Baby Wipes recalled – Investigation Underway (Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings)

Our office is investigating these potential claims in Georgia, Florida, and New Jersey.  Toll Free 866-373-1800 or email me personally at

Nutek Disposables has initiated a nationwide voluntary product recall at the retail level of all lots of baby wipes that it manufactured under the brand names Cuties,, Femtex, Fred’s, Kidgets, Member’s Mark, Simply Right, Sunny Smiles, Tender Touch, and Well Beginnings, because some packages may contain bacteria. These wipes were distributed by Nutek prior to October 21, 2014 to the following retail stores: Walgreens, Sam’s Club, Family Dollar, Fred’s, and

After receiving a small number of complaints of odor and discoloration, Nutek conducted microbial testing that showed the presence of a bacteria, called Burkholderia cepacia (B. cepacia), in some of these products. Soon after, on October 3, 2014 the company initiated a voluntary withdrawal of lots that had tested positive for the bacteria, as well as other baby wipes in the surrounding time frame. After some additional lots were tested, as a precautionary measure, Nutek believed it was a prudent decision to withdraw all its baby wipe products.

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. If you believe you have a weakened immune system or chronic lung disease and you have used one of the affected wipe products, you should call your doctor promptly for medical advice. B. Cepacia show a relatively poor virulence, that is capacity to cause disease. Virulence factors include adherence to plastic surfaces (including those of medical devices) and production of several enzymes such as elastase and gelatinase

From the FDA site:

The company is working with the U.S. Food & Drug Administration and the affected retailers and distributors throughout this process to address the issue.

Brand Name
RetailerLot Numbers of Product Manufactured by Nutek
CutiesInternet and various retailersAll Lots
Diapers.comDiapers.comAll Lots
FemtexFamily DollarAll Lots
Fred’sFred’sAll Lots
KidgetsFamily DollarAll Lots
Member’s MarkSam’s ClubAll Lots
Simply RightSam’s ClubAll Lots
Sunny SmilesWalgreensAll Lots
Tender TouchVarious retailersAll Lots
Well Beginnings*WalgreensCertain Lots±

- See more at:

Friday, October 10, 2014

Study warns about stimulants in diet supplements

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
Big news about a recent study involving DMAA with this title:

A synthetic stimulant never tested in humans, 1,3-dimethylbutylamine (DMBA), is identified in multiple dietary supplements.

Here is the conclusion: (Hint, they suggest a recall of all DMAA products):

Our objective was to determine if a stimulant never before sold for human consumption, DMBA, was present in dietary supplements sold by US distributors. We found that at least a dozen supplements sold by US distributors contain DMBA in dosages from 13 to 120 mg per serving. Given the potential health risks of untested pharmacologic stimulants, we strongly recommend that manufactures immediately recall all DMBA containing supplements. The FDA and other regulatory bodies should, without delay, warn consumers about the presence of DMBA in dietary supplements and clarify the legal status of DMBA. Until consumers can be assured that sports, weight loss and mind enhancing supplements do not contain untested pharmaceutical drugs, these products should be avoided.

Read it here:

Monday, September 22, 2014

An Illinois  compounding pharmacy is recalling a long list of drugs shipped to medical offices and patients in six states because the drugs-- which are inhaled, injected or used as eye drops-- may not be sterile.

Martin Avenue Pharmacy is recalling its compounded sterile preparations because patients who use them may be at risk of infection. There have not yet been any reports of illness or injury, according to the company. The company has stopped production of sterile products "until further notice."

The list is long. Find it in PDF format here:

Compounding Pharmacy Recalls Potentially Contaminated Drug Products

Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile. Pharmacy Creations no longer uses Front Range, Inc. for testing of any kind for any of its formulations.

Read more here:

Dried fish shipped nationwide recalled due to potential for botulism

A Brooklyn-based importer is recalling certain packages of its dried vobla -- a type of fish -- because they may be contaminated with the spores that cause botulism.

Tuesday, September 16, 2014

Regeneca Expands Recall of RegeneSlim Dietary Supplement

Regeneca Worldwide is expanding its voluntarily nationwide recall of RenegeSlim appetite control dietary supplement because FDA analysis confirmed the presence of DMAA. DMAA is 1,3-dimethylamylamind, methylhexanamine, or geranium extract. It can narrow blood vessels and arteries, which can cause a rise in blood pressure that increases the risk of heart attack.

FDA takes action against Georgia dietary supplement manufacturer

A dietary supplement manufacturer is under a federal court order to stop illegally marketing its products as treatments for disease, and to terminate the sale of supplements until the company complies with the U.S. Food and Drug Administration’s manufacturing regulations and other requirements. A federal judge issued the injunction against BioAnue Laboratories of Rochelle, Georgia, and its owner/operators, Gloria and Kelly Raber. 
BioAnue’s products were sold as supplements but were unapproved new drugs because they were marketed as treatments for conditions including cancer, HIV/AIDS, heart disease, chronic obstructive pulmonary disease, and diabetes, without approval from the FDA, according to the court order. The order was signed on July 23, 2014 in the United States District Court for the Middle District of Georgia.   
The defendants did not take appropriate corrective action in response to a FDA warning letter issued on Feb. 9, 2012, involving the marketing of the firm’s dietary supplements as unapproved new drugs. A follow-up FDA inspection in August 2012 revealed that BioAnue was also manufacturing products that were not in compliance with FDA’s current good manufacturing practice requirements for dietary supplements.
The permanent injunction prohibits the manufacture or distribution of products until the defendants hire independent experts to assist in bringing the firm’s manufacturing practices and labeling into compliance with the law.
District Judge Marc T. Treadwell said, in the court order, that the government was able to provide evidence that the defendants sold unapproved new drugs and failed to follow FDA’s current good manufacturing practice regulations for dietary supplements.
“The FDA is committed to ensuring that consumers do not become victims of false products claiming to cure diseases,” said Melinda Plaisier, associate commissioner for the FDA’s Office of Regulatory Affairs. “This firm has ignored previous FDA warnings, continued to produce and promote products with unproven claims and ignored good manufacturing practices.”
The defendants’ products include: TumoRx Cardio Clean, TumoRx Apoptosis Full Strength, TumoRx Formula CX, BioAnue Diabetic Mender, BioAnue Heart Mender, Stroke Mender, Cardiovascular Mender and Bovine Cartilage.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA warns of dangerous drugs in weight loss supplements: Tainted dietary supplements

The Food and Drug Administration is warning consumers that three weight loss supplements sold online and in some retail stores contain dangerous pharmaceutical ingredients hidden from consumers, and should be thrown away.

The supplements-- called LX1, Mezo, and Best Line Suplemento Alimenticio-- are part of a growing trend of dietary supplements sold for weight loss and sexual enhancement, usually advertised as "herbal" or "all natural," which really contain pharmaceutical ingredients.

According to FDA testing, LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. DMAA, an amphetamine derivative, is an illegal ingredient often sold in products that claim to boost energy, burn fat or build muscle. It can "can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack,"according to the FDA.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use LX1, a product promoted and sold for weight loss on various websites, including Dr. Skin Secretsdisclaimer icon, and possibly in some retail stores.LX1 Contains Hidden Drug Ingredient
FDA laboratory analysis confirmed that LX1 contains undeclared DMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract. Ingestion of DMAA can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.
Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care 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:
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.”  FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients.  Consumers should exercise caution before purchasing any product in the above categories. 

Friday, August 29, 2014

FDA warns consumers: Dietary supplements cannot treat concussions

Yadier Molina suffered a mild concussion on Ju...
Yadier Molina suffered a mild concussion on June 15, 2008 (Photo credit: Wikipedia)
The U.S. Food and Drug Administration is warning consumers about dietary supplements that falsely claim to prevent or cure concussions or other traumatic brain injuries. The FDA says supplements with labels that make these claims are not backed up by scientific evidence, and in a consumer alert issued Monday it urged users to beware.
It’s back-to-school time, and kids are already starting practice for football, soccer and other sports. It’s a time when parents may be thinking about sport safety and the potential for their kids to be injured by violent jarring and shocks.
Exploiting the public's rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).
The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease. The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes. These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.
One common but misleading claim: Using a particular dietary supplement promotes faster healing after a concussion or other TBI.
Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA's National Health Fraud Coordinator.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Coody. "Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs."
A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional. The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.
A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion. Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.
“There is simply no scientific evidence to support the use of any dietary supplement for the prevention of concussions or the reduction of post-concussion symptoms that would allow athletes to return to play sooner,” said Charlotte Christin, acting director of FDA’s Division of Dietary Supplement Programs.

False Claims

One of the first alarms that dietary supplements are promoted to treat TBI was raised by the U.S. Department of Defense.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, which is a hot-button issue," says Jason Humbert, a senior regulatory manager with FDA's Office of Regulatory Affairs. "That triggered our surveillance."
FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.
Typically, dietary supplements promising relief from TBIs tout the benefits of ingredients such as turmeric (an Indian spice in the ginger family) and high levels of omega-3 fatty acids derived from fish oil. In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have "the world's first supplement formulated specifically to assist concussion recovery," saying "it has the dynamic ability to minimize long-term effects and decrease recovery time." A National Football League player testified to its "proven results in my own recovery" from a concussion, and an unnamed "licensed trainer" said he had incorporated it into his "concussion management protocol."
Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, they could result in legal action taken without further notice, such as seizure or injunction.
Both companies changed their websites and labeling.
In December 2013, FDA issued a warning letter to another company for marketing its product with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them," says Coody. "If someone tells you otherwise, walk away."

FDA warns parents about getting their kids contact lenses

Lens cover for storing contact lens
Lens cover for storing contact lens (Photo credit: Wikipedia)
Dr. Elias Traboulsi, a pediatric ophthalmologist at Cleveland Clinic, says the FDA wants parents to know that age is not the only factor to consider getting contacts for your child
The discussion should not be "  my child wants contact lenses and they are responsible equals he gets them. There should be more thought into it and more caution about it," explained Traboulsi.
FDA researchers cite a 2010 study in the journal Pediatrics. It looked at the number of children taken to the emergency room each year for complications related to medical devices.
It found about 25% of the injuries were related to contact lenses. The most typical problems are infections and eye abrasions, which are often caused by a lack of hygiene.  That's why the FDA is warning parents who are considering contacts for their children to gauge their child's maturity level and whether they can handle the daily responsibilities.

Should You Consider This? Why I think it's a Mistake to consider OCP for acne treatment

Just out is a report on JAAD titled:

Meta-analysis comparing efficacy of antibiotics versus oral contraceptives in acne vulgaris

Here's the abstract, with my concerns below it:>


Both antibiotics and oral contraceptive pills (OCPs) have been found to be effective in managing acne vulgaris. Despite widespread use, few direct comparisons of efficacy between the 2 modalities have been published.


We compared the efficacy of antibiotics and OCPs in managing acne.


A meta-analysis was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane collaboration guidelines.


A review of 226 publications yielded 32 randomized controlled trials that met our inclusion criteria. At 3 and 6 months, compared with placebo, both antibiotics and OCPs effected greater percent reduction in inflammatory, noninflammatory, and total lesions; the 2 modalities at each time point demonstrated statistical parity, except that antibiotics were superior to OCPs in percent reduction of total lesions at 3 months (weighted mean inflammatory lesion reduction: 3-month course of oral antibiotic treatment = 53.2%, 3-month course of OCPs = 35.6%, 3-month course of placebo treatment = 26.4%, 6-month course of oral antibiotic treatment = 57.9%, 6-month course of OCPs = 61.9%, 6-month course of placebo treatment = 34.2%; weighted mean noninflammatory lesion reduction: 3-month course of oral antibiotic treatment = 41.9%, 3-month course of OCPs = 32.6%, 3-month course of placebo treatment = 17.1%, 6-month course of oral antibiotic treatment = 56.4%, 6-month course of OCPs = 49.1%, 6-month course of placebo treatment = 23.4%; weighted mean total lesion reduction: 3-month course of oral antibiotic treatment = 48.0%, 3-month course of OCPs = 37.3%, 3-month course of placebo treatment = 24.5%, 6-month course of oral antibiotic treatment = 52.8%, 6-month course of OCPs = 55.0%, 6-month course of placebo treatment = 28.6%).


Investigative treatment heterogeneity and publication bias are limitations.


Although antibiotics may be superior at 3 months, OCPs are equivalent to antibiotics at 6 months in reducing acne lesions and, thus, may be a better first-line alternative to systemic antibiotics for long-term acne management in women.

My concerns: In the Yaz litigation, Plaintiffs in claims over Yaz and Yasmin include allegations that the drugs were marketed and advertised in a way that exaggerated benefits such as acne reduction and downplayed serious dangers associated with the drug. Unfortunately, a client of ours who was prescribed the product to help with acne ended up (she alleges) with blood clots and DVT's that were so severe she had to endure multiple surgeries. I know and appreciate that this is just one instance of what she claimed was a horrible result, take the time to read what OCP's side effects are.