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Tuesday, November 25, 2014

Do not purchase or use Black Storm, FDA Recommendation

Black Storm: Public Notification - Undeclared Drug Ingredient

[Posted 11/24/2014]
AUDIENCE: Consumer
ISSUE: FDA is advising consumers not to purchase or use Black Storm. FDA laboratory analysis confirmed that Black Storm contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
BACKGROUND: Black Storm is a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.
RECOMMENDATION: Do not purchase or use Black Storm.
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:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[11/24/2014 - Public Notification - FDA]
[11/24/2014 - Tainted Sexual Enhancement Products - FDA]

FDA Drug Safety Communication Regarding Biogen Idec's Tecfidera (dimethyl fumarate)

Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported

[Posted 11/25/2014]
AUDIENCE: Neurology
ISSUE: FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.
PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems.
See the FDA Drug Safety Communication for additional clinical information about this case.

  • Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS), a brain and spinal cord disease in which patients experience multiple episodes of weakness, numbness, and other nervous system signs and symptoms that partially or completely resolve overs weeks or months. Patients may develop persistent symptoms and disability over time.
  • Approximately 4,000 patients have taken Tecfidera in MS clinical trials, including 1,000 patients treated for at least 4 years. Biogen reports that more than 100,000 patients with MS worldwide have taken Tecfidera since FDA approved it in 2013.

Friday, November 21, 2014

FDA Takes Enforcement Action Against Sandwich Company, Scotty’s Incorporated, Of Detroit, Michigan,

 FDA announced that it is seeking stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches, due to unsanitary conditions and for failing to comply with the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations.

The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop Scotty’s Incorporated, of Detroit, Michigan, which does business as Bruce Enterprises and Bruce’s Fresh Products, and Sandra J. Jackson, the firm’s co-owner and manager, from preparing and distributing ready-to-eat sandwiches.
Scotty’s has a history of manufacturing their ready-to-eat sandwiches under unsanitary conditions and failing to comply with the Seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
“Based on the company’s previous failure to maintain sanitation controls, the FDA is taking action to protect public safety,” said Melinda K. Plaisier, the FDA’s associate commissioner of regulatory affairs.
The FDA issued a Warning Letter to the company in 2009 for failing to have adequate controls and processes in place to minimize the risk of contamination and for failing to have a written HACCP plan for the tuna salad sandwiches prepared at the business. The Warning Letter referenced at least two inspections and cited observations of unsanitary practices and conditions in the facility. In October 2010 and February 2014, FDA investigators documented the company’s failure to manufacture, package and store food under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination. In addition, the defendants failed to make repairs and properly maintain equipment in the facility to prevent food from becoming adulterated.
The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA on November 21, 2014, in the U.S. District Court for the Eastern District of Michigan.
No illnesses have been reported to date associated with products from Scotty’s Incorporated, doing business as Bruce Enterprises and Bruce’s Fresh Products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is 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.

Wednesday, November 19, 2014

Losartan May Be An Effective Treatment Option For Marfan Syndrome

This randomized trial, which was conducted by the NHLBI’s Pediatric Heart Network, ran from 2007-2011 at 21 clinical centers in the United States, Canada and Belgium and included 608 patients aged 6 months to 25 years.  The two drugs work in different ways. Atenolol works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. Losartan also known as Cozaar, blocks the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.
The results of the Atenolol versus Losartan in Children and Young Adults with Marfan Syndrome study, supported by NIH’s National Heart, Lung, and Blood Institute (NHLBI), were presented today at the American Heart Association (AHA) Scientific Sessions in Chicago. The study was published simultaneously in the New England Journal of Medicine.

NIH Release

Tuesday, November 18, 2014

Almost Whole Of USA (85%) Has Reached Freezing Point 32F (0C)

I am so glad I live in California and I only get snow when I really wants it of when I have to be in the east coast for family matters, during winter.
According to Dr. Ryan Maue, of WeatherBell, Yesterday was the coldest November morning since 1976: More than 85% of the surface of the contiguous United States reached or fell below freezing. And yes we get to hear about places like Buffalo in the news but it is much the same for most folks and will continue to be so for sometime. Dr. Maue forecasts record breaking low temperatures, in decades or centuries, in some cases. Be mindful and be safe.
Average 19.3F Click to enlarge.

" Record lows from Idaho to Nebraska and Iowa south to Texas and east through the Great Lakes, the eastern 2/3 of the US will shatter decades-long and in some cases, century-long records. Temperatures east of the Rockies will be 20-40°F below climate normals.
Brisk northwesterly winds in the Great Lakes will cause heavy lake effect snow which will be measured in feet from Michigan to New York state. Monday, almost half of the Lower-48 was blanketed in snow. Please visit Mashable and Washington Post Capital Weather Gang for daily updates.

Cold air pushes east thru Wednesday with a reinforcing shot of Arctic air with origin from the North Pole & Siberia to arrive on Thursday in the Great Lakes. Any relief is is 5-6 days away as Chicago, Minneapolis, and Detroit will struggle to rise above freezing until Saturday. 

India Has It's First Case Of Ebola

An Indian national who contacted and was cured of Ebola, has tested positive for the virus. He was in Liberia when he got infected. This makes the India's first known case of Ebola.

The patient was supposedly treated in Liberia and cured but was quarantined as a precaution when he arrived in New Delhi on Nov. 10. He has not displayed symptoms of Ebola, but his semen showed traces of the virus,  said in a statement Tuesday.

"It is a known fact that, during convalescence from Ebola Virus Disease, persons continue to shed virus in bodily fluids for variable periods, However, presence of virus in his semen samples may have the possibility of transmitting the disease through sexual route up to 90 days from time of clinical cure.India's health ministry has said.
Peter Piot, a former WHO official who was one of the discoverers of the virus, has in the past expressed concerns about the disease spreading to India. There are nearly 45,000 Indian nationals living in West Africa. Densely populated India is not adequately prepared to handle any spread of the highly infectious hemorrhagic fever among its 1.2 billion people.
Times of India

Sunday, November 16, 2014

Preventing Carbon Monoxide Poisoning

The winter is coming and there could be interruptions to electricity due to storms and other emergencies, leading to seek other power solutions. Always use portable generators, camp stoves, and charcoal and gas grills outside to prevent deadly CO poisoning.
  • Never use a gas range or oven to heat a home.
  • Never leave the motor running in a vehicle parked in an enclosed or partially enclosed space, such as a garage.
  • Never run a motor vehicle, generator, pressure washer, or any gasoline-powered engine outside an open window, door, or vent where exhaust can vent into an enclosed area.
  • Never run a generator, pressure washer, or any gasoline-powered engine inside a basement, garage, or other enclosed structure, even if the doors or windows are open, unless the equipment is professionally installed and vented. Keep vents and flues free of debris, especially if winds are high. Flying debris can block ventilation lines.
  • Never use a charcoal grill, hibachi, lantern, or portable camping stove inside a home, tent, or camper.
  • If conditions are too hot or too cold, seek shelter with friends or at a community shelter.
  • If CO poisoning is suspected, call your local Poison Control Center at 1-800-222-1222 or consult a health care professional right away.
More info at CDC


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