Monday, July 29, 2013

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).

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.

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.

Saturday, July 27, 2013

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.

Monday, July 08, 2013

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.

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.

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.

Friday, July 05, 2013

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)].

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.