How do you measure excellence? We believe excellence is an ongoing process, achieved only through progression, momentum, and constantly thinking forward, moving
forward.
Goliath Labs is best known for its commitment to quality. We have spent a great deal of time and effort to ensure that our state of the art production facility is supported by an equally impressive chemical and microbiological laboratory.
» Read more about Goliath Labs…
Scientific advances and innovative medical technologies have provided Americans with the potential for longer, healthier lives. But persistent and well-documented health differences exist between various ethnic, racial, and social communities.
Learn about the establishment of FDA’s Office of Minority Health (OMH) and how it is addressing minority health and health disparities during a 30-minute webinar.
Michelle Yeboah, Dr.P.H., acting director of OMH, will discuss:
When: Monday, May 21, 2:00 p.m. EST
Length: 30 minutes
Where: To join the webinar, see the instructions at http://www.fda.gov/AboutFDA/Transparency/Basics/ucm304116.htm.
Host: FDA’s Office of Minority Health
Featured speaker: Michelle Yeboah. Dr.P.H., acting director of the FDA Office of Minority Health.
This webinar is part of a series of online sessions hosted by different FDA centers and offices. The series is part of FDA Basics, a Web-based resource aimed at helping the public better understand what the agency does.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 18, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm304588.htm
After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including
Report problems to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness, or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
FDA is warning of possible risks for people with diabetes or kidney disease who use blood pressure medicines containing aliskiren in combination with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). ACEIs and ARBs relax blood vessels by blocking the effects of a hormone that causes vessels to narrow.
These drug combinations should not be used in people with diabetes or with moderate to severe kidney disease. The labels for the aliskiren drugs below are being updated based on early data from a clinical trial, Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).
Risk: People with diabetes who take aliskiren with ARBs or ACEIs are at risk for kidney disease, low blood pressure and higher-than-normal potassium levels. People who already have kidney disease should also avoid aliskiren.
Recommendations
For More Information
FDA Drug Safety Communication on Using Aliskiren With ACEIs and ARBs
FDA Consumer Update: Medications for High Blood Pressure
At FDA’s request, U.S. Marshals have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained two dangerous bacterial strains: Pseudomonas aeruginosa and Klebsiella oxytoca. The seizure included all lots of the gel manufactured between June 2011 and December 2011. FDA has also notified health care professionals and facilities to stop using this gel manufactured between these dates.
The product is a non-sterile gel used to improve the transmission of ultrasound waves. Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body.
Risk: People exposed to the bacteria Pseudomonas aeruginosa on the surface of their skin could develop itchy red skin with raised, weepy bumps (inflammatory dermatitis, also known as eczema). Klebsiella bacteria in the lungs or some other tissues may cause serious infections such as pneumonia, wound infection, or bloodstream infection.
Health care professionals have been advised to identify their patients who have been exposed to the contaminated gel to determine if further evaluation is needed. Be aware that the only ultrasound gel that is sterile is an unopened ultrasound gel container or packet labeled as sterile.
For More Information
FDA Safety Communication on Other-Sonic Generic Ultrasound Transmission Gel
Birth control pills that contain drospirenone may be associated with a higher risk of blood clots than other progestin-containing pills. FDA bases this conclusion on its review of recent studies on the risk of blood clots in women taking drospirenone-containing birth control pills.
Drospirenone is a synthetic version of the female hormone progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills, which include:
Risk: The revised drug labels will state that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, but other studies found no additional risk of blood clots with drospirenone-containing products.
Recommendation: Women should talk to their health care professional about their risk for blood clots before deciding which birth control method to use.
For More Information
FDA tests found that X-Rock, marketed as a dietary supplement for men, contains the active ingredient sildenafil found in an FDA-approved prescription drug product used to treat erectile dysfunction.
X-Rock for Men, sold in one-capsule blister cards, was distributed nationwide to wholesalers and to consumers through the Internet.
Risk: The active ingredient sildenafil may interact with prescription drugs containing nitrates (such as nitroglycerin) and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed drugs containing nitrates. Another similar active ingredient found in X-Rock may also interact with nitrates and cause side effects, such as headaches and flushing.
Recommendations
For More Information
In March 2012, FDA required safety labeling changes to be made to 39 products, including five different drugs that now carry a warning that they should not be taken by pregnant women because of the risk of injury and death to the developing fetus.
For More Information
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 15, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm304093.htm
In early March 2012, federal officials learned of infections from Salmonella Bareilly, bacteria that can cause diarrhea, fever and abdominal cramps if eaten in contaminated food. Left untreated, the illness can lead to death in high-risk populations, such as infants, older adults, and pregnant women.
Since then, about 250 people have been infected in 24 states and the District of Columbia, according to the Centers for Disease Control and Prevention (CDC).
The source of this outbreak is no longer a mystery, thanks in part to the efforts of the Food and Drug Administration’s (FDA) special urgent-response unit—the Incident Management Group (IMG). “The IMG serves as the agency’s focal point for coordinating emergency response activities,” says Ellen Morrison, director of the agency’s Office of Crisis Management.
The IMG operates out of the high-tech Emergency Operations Center (EOC) at FDA headquarters in Silver Spring, Maryland, and shifts into high gear when an emergency arises. The group’s composition varies according to the type of emergency, which could be an outbreak or a different kind of crisis.
“For the Salmonella outbreak, we assembled more than 30 agency experts in the EOC from offices across the agency to investigate the outbreak and track down its source,” says Mark Russo, director of FDA’s Office of Emergency Operations, a component of the crisis-management office directed by Morrison.
In the end, the prime suspect was a frozen raw yellowfin tuna product, called Nakaochi Scrape, imported from India. This tuna is used to make sushi, and many of the people who became ill reported eating sushi, with spicy tuna a common ingredient.
The road to that conclusion was long and winding.
And the journey actually started with FDA’s Coordinated Outbreak Response and Evaluation Network (CORE). This branch of FDA—on the frontlines of response to outbreaks of foodborne illness—evaluated and monitored the initial reports.
When the size, scope, severity and complexity of an outbreak require more staff and greater coordination, CORE may elevate the response to the IMG level and work from the EOC with colleagues from other parts of the agency and CDC.
Beginning on April 2, 2012, and for the next three weeks, Russo says, FDA experts on such subjects as outbreak investigation coordination, epidemiology, public and environmental health, food safety, seafood, imported products, legal issues, and cartography scrutinized thousands of pages of invoices, shipping records and bills of lading.
“There were probably hundreds of dedicated people from the FDA and other federal, state, and local agencies trying to pinpoint the outbreak’s cause,” Russo says. CDC worked with state and local public health officials to coordinate the epidemiologic aspects of the investigation, analyzing data that includes information on the cases, their distribution, and risk factors.
Meanwhile, local and state health agencies continued to interview people who had become ill. “But you’d be surprised,” Morrison says, “Not everyone has accurate recall when it comes to exactly what they ate on a certain date and where.”
By early April, CDC had identified six clusters of cases around restaurants or grocery stores in five states. Interviews suggested that the common food consumed and likely source of infection was sushi made with raw tuna—and specifically, spicy tuna.
This was just the beginning. “We needed to keep narrowing the focus down,” Morrison explains. “These groceries and restaurants may have used the same supplier or distributor. They may have used the same packager or manufacturer.”
After analyzing reams of data, the IMG selected and mapped four of the clusters of illnesses in Connecticut, Rhode Island, Texas, and Wisconsin as the investigation’s focus. Further analysis verified that all four had received the same imported, frozen raw Nakaochi Scrape tuna product from a single tuna processing facility in India.
With the source identified, FDA quickly alerted consumers and health agencies to the potential dangers of eating the recalled product. FDA provided information on symptoms of illness, at-risk populations, and precautions consumers can take in the future.
The company that imported the tuna from India—Moon Marine USA Corporation of Cupertino, California—voluntarily recalled the product.
Outbreaks like this are only one kind of crisis that sends EOC into action. Morrison or her designee may activate it during incidents or events that require more complex levels of response than would ordinarily be provided. That includes:
In 2011, the EOC was activated three times to
“I’ve worked in emergency operations for more than 15 years,” Morrison says. But I still find it impressive to walk into the EOC and watch the experts in action. They are the core of a massive team effort.”
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 3, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm302779.htm
Thanks to nick of perfect body,i was offered a bottle of each of this product to sample a few guys.
so far i and 2 other guys have tried it and these are our reviews on it,
now im going to keep the detail in very basic terms so no one gets offended as its not a product intended for muscle and strentgh,but i was actually proven wrong on this too so read on,
first will start off with my mate,he is 21 years old.
his first trial with the product was on wednesday,
» Read full review…
