Monday, June 21, 2010

FDA Warns Consumers to Avoid Magic Power Coffee

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

Consumers who have Magic Power Coffee should stop using it immediately. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death.

In the case of Magic Power Coffee, the FDA collected and analyzed the product and determined that the product contains hydroxythiohomosildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Hydroxythiohomosildenafil, like sildenafil, may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. Consumers and health care professionals should be aware of this problem and the health hazard it presents.

When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness.

"Because this product is an instant coffee labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research, Office of Compliance. "In fact, Magic Power Coffee can cause serious harm.”

To date, the FDA is not aware of any adverse events associated with the use of this product.

The product is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multi-level marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.

The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to consult a health care professional and to safely discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

During the past several years, the FDA has found many products marketed as dietary supplements for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs or other compounds that do not qualify as “dietary ingredients.”

“The FDA is committed to protecting public health and stopping the illegal marketing of unapproved drugs,” said Autor. “We support vigorous law enforcement and criminal prosecution of violators of safe drug laws.

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Thursday, June 17, 2010

FDA Warns About Fraudulent Tamiflu

/USNewswire/ -- The U.S. Food and Drug Administration today warned consumers about a potentially harmful product represented as "Generic Tamiflu" sold over the Internet. FDA tests revealed that the fraudulent product does not contain Tamiflu's active ingredient, oseltamivir, but cloxacillin, an ingredient in the same class of antibiotics as penicillin.

The agency reminds patients who are allergic to or may have experienced adverse reactions from penicillin products that they are at risk of experiencing similar reactions from cloxacillin. This includes a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse. To date, the FDA is not aware of any reports of adverse reactions.

There is no FDA-approved generic drug for the prescription product Tamiflu.

The FDA bought the fraudulent "Generic Tamiflu" without a prescription from a website claiming to be an online drugstore that is no longer operational. The fraudulent version is likely to be found for sale on other websites, however.

"A rogue Internet website marketing drug products may look like a professional and legitimate website, but may actually be an illegal operation," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "Medicines purchased from websites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient."

The FDA-purchased product arrived in an envelope postmarked from India, containing two foil-backed blister packages each with 15 yellow and tan capsules containing white powder (see photos below). The foil backing is printed, and labeled in part, "Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules" and "Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD."

Although the FDA actively monitors the Internet and when appropriate purchases and analyzes drug products, consumers who purchase drugs using an online pharmacy can protect themselves by knowing how to recognize a legitimate Internet pharmacy and how to buy medicines safely online. Legitimate internet pharmacies are licensed by the appropriate U.S. Board of Pharmacy and follow the applicable laws and regulations.

Consumers can also be confident that the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal, also known as VIPPS Seal, gives a seal of approval to pharmacy sites that apply and meet state licensure requirements. Legitimate pharmacies that carry the VIPPS seal are listed at www.vipps.info

The FDA advises anyone possessing or encountering any of these fraudulent Tamiflu drugs not to use them and to contact the FDA's Office of Criminal Investigations by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI).

Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these fraudulent products to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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Wednesday, June 16, 2010

Who Will Hold BP Liable?

24-7 - The Ultimate Losses

No one lost more than those 11 workers who died on April 20 in the massive explosion that engulfed the offshore oil rig in flames and sent it into the then-blue water of the Gulf. Their loss of life has been largely overlooked in the nonstop media coverage that has followed in the weeks since the catastrophe. The workers who suffered severe injuries in the explosion have likewise been ignored.

One day those survivors and those who were injured will have their day in court, however, and liability and compensation for their losses will be determined. Who will be held liable? BP has already to some extent admitted liability in the event by paying out minor sums to fishermen and other business owners and workers who have lost income because of the oil spill.

Two other companies may well share liability in the Deepwater incident: Transocean, the owner of the Deepwater Horizon rig (Transocean leased the rig to BP) and Halliburton, the company that was responsible for the cement casing that was supposed to cap the well.

Injuries Incurred Since the Explosion

As part of the efforts to prevent the enormous swaths of oil from the leak from hitting the Gulf coast, BP has hired shrimpers, commercial fishermen and others with boats to deploy booms and devices to soak up some of the oil.

Though the efforts have had decidedly mixed results, there's no denying that some of the workers hired by BP have suffered a variety of symptoms due to their prolonged (and in some cases, unprotected) exposure to toxic fumes, oil particles and powerful chemical dispersants used to break up the oil.

A CBS News report aired nationally showed Gulf coast workers reporting a variety of respiratory and other ailments after exposure to the oil and dispersants.

The Los Angeles Times reported that seven workers were hospitalized due to sudden illness. According to Dr. David Michaels, assistant secretary of labor for the Occupational Safety and Health Administration, the illness was apparently caused by exposure to a cleaning substance.

Crude oil is a poisonous stew with ingredients including cancer-causing benzene and polycyclic aromatic hydrocarbons, a toxin that can damage the central nervous system and brain.

The legal process is already beginning to sort out issues involving negligence and liability and compensation for lost wages, medical bills and pain and suffering. Legal experts urge people who have suffered injuries, or have family members who are oil-spill victims, to carefully consider their legal options before entering into agreements with BP or others.

Article provided by Winters & Yonker P.A.

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Tuesday, June 15, 2010

FDA Cautions on Accurate Vitamin D Supplementation for Infants

The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.

The FDA also advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 IU.

The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. The AAP’s recommendations are provided hereExit Disclaimer.

Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage.

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Tuesday, June 08, 2010

Cotton Is King: Dynamic Adsorbents, Inc. Develops Superior Cotton-Based Solution for Removing Oil from the Gulf of Mexico

/PRNewswire/ -- The British Petroleum (BP) oil spill controversy is raising eyebrows worldwide not only because of spewing an unprecedented volume of crude oil, but because proven technologies are being overlooked that can dramatically reduce the effects of the spill.

Dr. Mark Moskovitz, President and CTO of Dynamic Adsorbents, Inc. (DAI), has spent his career in separation technology and is outraged by the clean-up decisions.

"While our environment is being destroyed right before our eyes, the problem is being compounded by decisions to use inferior products and technologies to remediate the effects," Dr. Moskovitz said. "While BP may not be able to fully stop the flow of oil, it and the Federal Government have a responsibility to ensure that the best technologies are considered."

BP has recently sprayed almost one million gallons of Corexit Chemical dispersant into the ocean to dissipate the crude oil. Unfortunately, the toxic dispersant is causing adverse health effects to the people cleaning up the spill.

DAI's solution is alumina impregnated cotton.

"Cotton's absorbency power is woefully unrecognized and should be at the forefront of consideration for cleaning up this disaster," Dr. Moskovitz said.

The oil sorption capacity of many natural and man-made fibrous sorbents have been studied for years. Industry professionals are aware that natural sorbents such as milkweed, kapok, cotton and wool are far superior in their sorption capacity properties when compared to man-made sorbents.

"Natural sorbent capacities routinely exceed 30 grams of oil per gram of fiber," Dr. Moskovitz said. "Cotton is the superior choice out of all the natural sorbents due its sorption capacity exceeding 40 grams."

Dr. Mark Moskovitz and Hobbs Bonded Fibers, Inc. in Waco, TX, have co-developed a new generation of cotton materials impregnated with patent-protected alumina adsorbents. "Cotton, impregnated with activated alumina, should be used for absorbing the toxic chemicals and crude oil from the Gulf due to its ability to adsorb as much as 100 grams per gram of cotton, exceeding 2 1/2 times more than any other cotton-based products," according to Dr. Moskovitz.

Carey Hobbs, CEO of Hobbs Bonded Fibers, Inc., has spent his entire career in the textile industry and is at the forefront of its newest technologies. When Hobbs' superior cotton material is impregnated with DAI's customized activated alumina, the material will have the highest sorption capacity and will remove fumes and noxious airborne particulate materials through adsorption, addressing the problem of workers inhaling dangerous materials.

"The BP disaster is an example of an environmental disaster that we are ready to address now," Hobbs said. "We at Hobbs Bonded Fibers are thrilled to be working with Dr. Moskovitz and his scientific team. Dr. Moskovitz's expertise enhances the absorbency power of cotton, making this material the perfect tool for handling this catastrophe."

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Saturday, June 05, 2010

Gulf Coast Poison Centers Respond to Oil Spill

/PRNewswire/ -- More than 100 people have called Gulf region poison centers since the Deepwater Horizon oil platform caught fire in the Gulf of Mexico April 20, either to receive information or to report side effects from the resulting oil spill.

Dr. Mark Ryan, managing director of the Louisiana Poison Center, said he expects to see that number rise as the oil continues to leak and spread.

"Louisiana is a particularly difficult area to clean because the marshes are grassy with muddy bottoms that have very low oxygen content," he said. "It's not conducive to breaking oil down. We may be dealing with this for decades."

As of June 2, Gulf region centers reported a total of 45 calls reporting a poison exposure related to the spill. An additional 64 callers have contacted their poison center to seek medical information about the spill.

The U.S. Coast Guard and the Louisiana Department of Health and Hospitals are among the agencies urging those exposed to toxins related to the spill to call their local poison center for guidance, and the Louisiana center is working with the state's Center for Epidemiology and Environmental Toxicology to gauge the number of poison exposures related to the spill. "We are collaborating to obtain the most comprehensive picture of the exposures that are occurring," Ryan said.

In addition, the Gulf region poison centers are providing data to federal agencies including the U.S. Centers for Disease Control and Prevention, the U.S. Environmental Protection Agency and the National Institutes of Health.

Poison centers provide information about calls to the American Association of Poison Control Centers National Poison Data System. When someone calls a poison center after being exposed to an oil spill-related poison, be it skin contact with oil, inhalation of fumes, or exposure to the dispersants used to treat the spill, staff at the centers enter a "tracking code" that links the call to the oil spill. This marks the first time one code has been used to track the varied exposures and medical outcomes stemming from a disaster with potentially wide-reaching consequences.

So far, the most common symptom reported to centers has been throat irritation, followed by headaches. Other callers have reported symptoms including nausea, chest pain, dizziness and coughs. Most calls so far have involved inhalation of fumes. Poison centers in Alabama, Florida, Louisiana, Missouri and Mississippi have received calls about poison exposures related to the spill.

"Poison centers are perfectly poised to be a go-to health care resource during a disaster," said Jim Hirt, executive director of the American Association of Poison Control Centers. "There's a reason that state and federal health agencies are relying on information from Gulf region poison centers - these centers provide an invaluable public health service."

Poison centers are available 24 hours a day, seven days a week, 365 days a year. Their services are free and confidential. If you have a question about medical effects of the oil spill or any other poison exposure, call your local poison center at 1(800) 222-1222.

About the American Association of Poison Control Centers: The American Association of Poison Control Centers is a non-profit, national organization founded in 1958 that represents the poison control centers of the United States, the interests of poison prevention and the treatment of poisoning.

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Friday, June 04, 2010

McDonald's(R) USA Voluntarily Recalls Shrek Forever After(TM) Glassware

/PRNewswire/ -- In collaboration with the Consumer Product Safety Commission (CPSC), and as a precautionary measure, McDonald's USA today issued a voluntary recall of its four Shrek Forever After(TM) glassware recently offered in its U.S. restaurants. Customers should stop using the glasses and visit www.mcdonalds.com/glasses beginning June 8 for instructions on how to return them and get a refund.

McDonald's safety standards are among the highest in the industry and the company has a strong track record. To be clear, the glassware was evaluated by an independent third-party laboratory which is accredited by the CPSC, and determined to be in compliance with all applicable federal and state requirements at the time of manufacture and distribution. However, in light of the CPSC's evolving assessment of standards for cadmium in consumer products, McDonald's determined in an abundance of caution that a voluntary recall of the Shrek Forever After glasses is appropriate.

"When the U.S. Consumer Product Safety Commission approached McDonald's about cadmium in their current movie-themed drinking glasses, the company responded quickly, agreed to cooperate fully and acted on the side of caution," said Scott Wolfson, Director of the Office of Information and Public Affairs, CPSC. "The glasses have far less cadmium than the children's metal jewelry that CPSC has previously recalled."

McDonald's has a longstanding, cooperative relationship with the CPSC, and continues to follow their lead as testing protocols and new scientific information becomes available.

The Shrek Forever After glassware was offered in four glass designs at McDonald's restaurants beginning May 21. The four designs include Puss n' Boots, Shrek, Princess Fiona and Donkey. Customers can get instructions to return the glassware and request a refund by visiting www.mcdonalds.com/glasses beginning June 8. Customers can also call McDonald's toll-free number at 1-800-244-6227. Previous McDonald's promotional glassware is not involved in the recall.

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Wednesday, June 02, 2010

HIV Tests Can Do More Harm Than Good

/PRNewswire/ -- The idea of early detection and cure is appealing. But if the test is unreliable, and the treatment itself harmful, universal testing can do more harm than good.

The availability of highly active antiretroviral treatment (HAART) for AIDS is leading to calls for universal testing for human immunodeficiency virus (HIV), which can progress to AIDS, and for early use of this expensive drug cocktail.

While HIV testing is said to be highly reliable, Professor Henry Bauer points out that in a population at low risk for AIDS, a positive test is nonetheless quite likely to be a false positive. Moreover, many people with genuinely positive tests never get AIDS.

The number of "long-term nonprogressors" is not known, but in an article (http://www.jpands.org/vol15no2/bauer.pdf) in the summer issue of the Journal of American Physicians and Surgeons, Bauer calculates that more than half of those tagged as "HIV positive" in a universal testing program could be either false positives or long-term nonprogressors.

Being pregnant, or simply being black, is a risk factor for a false positive HIV test. Tests are calibrated the same for Africans as for Europeans, although blacks are likely to have "sticky serum" that reacts somewhat differently. Thus, HIV tests are racially biased. It is incorrect to assume that black men are more promiscuous, or more likely to be bisexual, just because they are more likely to be HIV positive, Bauer states.

The HAART regimen is so toxic that 40 percent of prescriptions are not filled. Side effects include heart, liver, and nerve damage.

A positive HIV test can also destroy a person's marriage, employability, insurability, and peace of mind. These tests should be used only where indicated, rather than as screening tools, and only with fully informed consent, Bauer states.

"Disproportionate harm from aggressive testing and treatment will be experienced by pregnant women and persons of black African ancestry," he emphasizes.

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