LipoBIND - Fat blocker made from natural dried cactus extract. While reducing fat intake is certainly associated with dieting, it is also among the goals of those with perfectly healthy weights who take LipoBIND. Fat is one of the more dangerous elements of food and, though our bodies require a certain amount of it to function correctly, the amounts contained in many of the most popular dishes are far in excess of what's needed and what's healthy. Reducing this fat intake can have significant effects on one's overall health and, fortunately, this goal can be accomplished with the use of entirely natural ingredients which are safe for the vast majority of individuals.

LipoBIND is made out of cactus leaves. The substances contained in these leaves bind with fat. When the two merge, they create a sort of gel of dietary fiber and fat which is passed harmlessly from the body along with any other waste. This can reduce the amount of fat that one receives from their food by as much as 27 percent, according to the manufacturer's literature. There are other ways in which LipoBIND is designed to make losing weight easier and more convenient than it tends to be otherwise.

LipoBIND helps to control one's appetite. Most appetite problems are caused by sharp peaks and valleys in one's blood glucose levels. When the levels plummet, the body will demand food and this can make it exceedingly difficult for one to stick to their diet program. LipoBIND helps keep the body's glucose levels regular which allows individuals to enjoy the sensation of being satisfied by a meal for longer and reduces the risk of one indulging a bit too much when they become hungry and, thus, ruining all the work they put toward reducing their weight in the first place.

It is recommended that one takes a vitamin supplement along with LipoBIND. The company offers its own line of supplements to go along with their LipoBIND product. Because the substances in the supplement will bind with the vitamin, it's not recommended to take a dosage of LipoBIND for 2 hours after having taken one's vitamins. This supplement is taken after meals when the materials in LipoBIND can bind with what food is in the stomach and ensure that the total amount of fat intake is not absorbed by the body. This also helps the body digest more slowly, reducing further the rate at which hunger returns.

LipoBIND is used by some individuals as a means of maintaining their already healthy weight as well as by those who need to lose weight in the short term. When it's used as a preventative supplement, the dosages are a bit different and all of this information is detailed on the manufacturer's literature. There are ceiling amounts which should be taken in the course of a day and one should adhere to these recommendations to ensure the best results and to ensure their overall health. This supplement is not recommended for those who are currently pregnant or nursing.

more info at Weight Loss. True Story Blog

FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:

• ensure that the risks of Raptiva do not outweigh its benefits;
• that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
• that health care professionals carefully monitor patients for the possible development of PML.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

Read the FDA’s 2009 Public Health Advisory

FDA Issues Early Communication about a Safety Review of Xigris

The U.S. Food and Drug Administration today announced that it is working with the maker of Xigris (drotrecogin alfa activated), Eli Lilly and Company, to further evaluate the incidence of serious bleeding events and death in patients who receive Xigris, a drug used to treat severe sepsis (a blood stream infection).

A recent study and an accompanying editorial published in the journal Critical Care Medicine reported an increased risk of serious bleeding events and death in patients with sepsis and baseline bleeding risk factors who received Xigris. The study, a retrospective review of medical records of 73 patients who were treated with Xigris, found that serious bleeding events occurred in seven of 20 patients (35 percent) who had a bleeding risk factor versus two of 53 (3.8 percent) of patients without any bleeding risk factors. More patients with baseline bleeding risk factors died (13 of 20, or 65 percent) compared with patients without any bleeding risk factors (13 of 53, or 24.5 percent). As noted by the authors, limitations of this study include the retrospective design (looking back at events that already have taken place) and small patient population.

Xigris is known to increase the risk of bleeding. The drug’s current prescribing information (labeling) includes a warning that describes bleeding as the most common serious adverse effect and lists a number of risk factors that should be carefully considered when deciding whether to use Xigris. The labeling contraindicates the use of Xigris in several clinical situations where bleeding could lead to significant adverse reactions or death.

The FDA is not recommending that prescribers stop administering this medication. Consumers and health care professionals should notify the FDA of any complaints or problems associated with this product. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.

The FDA uses a variety of tools to communicate important and sometimes emerging drug safety information. Early Communications mean that the FDA has begun an ongoing safety review about an important drug safety issue that has not yet been fully analyzed or confirmed by the agency. The FDA will announce its conclusions and any resulting recommendations to the public when the review of Xigris is completed, which may take several months.

The full Early Communication can be found here: http://www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html

FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States

The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.

The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display today.

"This initiative creates incentives for drug makers to develop and maintain secure supply chains," said Deborah Autor, Director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "This is one of several agency initiatives to enhance drug product safety."

Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants will need to meet the pilot's criteria, including a requirement that they maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.

"With the increase of drug products produced outside the United States, it is critical that the FDA concentrate its resources on companies that pose the highest risk of importing products that don't meet the FDA's standards and violate U.S. laws," said Michael Chappell, acting Associate Commissioner for Regulatory Affairs at FDA. "Consumers should know that only companies that maintain control over their products will be selected into this pilot program."

Companies wishing to participate in the two year pilot program must meet certain criteria, including:

• For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
• The active pharmaceutical ingredients imported must be used only to make FDA‑approved drugs;
• Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
• Applicants must show that their drug products use a secure supply chain.

The pilot program is planned to run for a period of two years.

To view the application for the program: http://www.fda.gov/cder/fedreg/fda-3676.pdf

To view the displayed federal register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-N-0656-N.pdf

Bloomberg News

The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 41 more tainted weight loss products that may put consumers’ health at risk.

The tainted weight loss products are:

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) and bumetanide (a diuretic). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers' health at risk.

These weight loss products, some of which are marketed as “dietary supplements,” are promoted and sold on various Web sites and in some retail stores. Some of the products claim to be “natural” or to contain only “herbal” ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by the FDA, are illegal and may be potentially harmful to unsuspecting consumers.

The FDA advises consumers who have used any of these products to stop taking them and consult their healthcare professional immediately. The FDA encourages consumers to seek guidance from a healthcare professional before purchasing weight loss products.

“These tainted weight loss products pose a great risk to public health because they contain undeclared ingredients and, in some cases, contain prescription drugs in amounts that greatly exceed their maximum recommended dosages,” said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. “Consumers have no way of knowing that these products contain powerful drugs that could cause serious health consequences. Therefore FDA is taking this action to protect the health of the American public.”

The FDA has inspected a number of companies associated with the sale of these illegal products, and is currently seeking product recalls. Based on the FDA’s inspections and the companies’ inadequate responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia (rapid heart beat), palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.

Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.