FDA Announces Recall of Tren Xtreme and Mass Xtreme Following a Guilty Plea by the Drugs’ Manufacturer

California-based sports nutrition company, VMG Global, pleaded guilty in federal court to charges associated with the selling of dietary supplements containing illegal steroids that may pose a number of health risks, including liver failure.

VMG has agreed to pay up to $500,000 in penalties and destroy its inventory of two drugs, Tren Xtreme and Mass Xtreme. The FDA says the massive recall of the two products should serve as a warning to other dietary supplement companies that may be using unapproved and harmful ingredients with the intent to defraud and mislead consumers.

As a result, another sports nutrition company, MuscleMaster.com, has announced a voluntary recall of 17 dietary supplements.

Consumers taking body building supplements that claim to contain steroids or steroid-like substances should stop taking them immediately. Healthcare professionals and consumers are encouraged to report adverse events that may be related to the use of these types of products to the FDA’s MedWatch Program by phone at 1 (800) FDA – 1088.

The lawyers of Aylstock, Witkin, Kreis and Overholtz, Florida’s best personal injury attorneys, are ready to represent you. AWKO Law has successfully tried a number of defective drug cases. Contact the AWKO team at (888) 255 – 2956 if you believe that you mays have developed a serious medical condition as a result of Tren Xtreme and/or Mass Xtreme.

FDA Issues a Warning Letter to Bayer over the Serious Health Risks Associated With Popular Oral Contraceptives Yaz and Yasmine

Lawsuits against Bayer, the manufacturer of Yaz and Yasmin, may soon reach thousands. Yaz and Yasmin are being targeted by the Food and Drug Administration (FDA) because the organization determined the birth control pills are both dangerous and less effective than originally advertised.

Yasmin and Yaz are both low estrogen oral contraceptives. Yasmin was approved in the U.S. in 2001, while Yaz – which contains even less estrogen – was approved in 2006. Together, the pills generated approximately $1.8 billion for Bayer HealthCare last year alone. According to The New York Times, Bayer has positioned them as the “go-to drug brands for women under 35.” Yaz, which is the top-selling birth control pill in the U.S., has been marketed by Bayer as “a quality-of-life treatment to combat acne and severe premenstrual depression.”

However, according to several FDA reports, the oral contraceptives have been linked to a number of health risks related to blood clots, and thousands of young women have suffered debilitating injuries, including deep vein thrombosis (DVT), stroke, heart attack, pulmonary embolism and even death.

YAZ contains a synthetic type of progestin called drospirenone, which can lead to hyperkalemia, a condition caused by excessive amounts of potassium in the blood. Hyperkalemia may result in potentially serious heart problems, as well as other medical conditions, including kidney failure.

Most recently, the FDA has issued a warning letter to Bayer HealthCare Pharmaceuticals, Inc. regarding what it termed as “misleading” advertising spots that it found “particularly troubling” because they failed to communicate important health risk information. The FDA claims that the ads suggest that Yaz and Yasmine are safer than concluded in clinical trials.

In the meantime, Bayer has refused to recall the drugs, claiming the pills do not pose any additional health risks than any other product containing estrogen.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s premier personal injury attorneys. AWKO Law has succesfully tried a number of defective drug cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your right for compensation.

FDA Announces Investigation after Clinical Study Concludes Three Anemia Drugs May Lead to Heart Attack and Stroke

The Food and Drug Administration (FDA) announced plans to investigate the health risks associated with use of three anemia drugs marketed by Amgen and Johnson & Johnson. The announcement comes after another clinical trial concluded that certain doses of anemia drugs Epogen, Aranesp and Procrit may lead to heart attack and stroke.

The three widely used anemia drugs have been prescribed to patients following chemotherapy and those who suffer from anemia as a result of chronic kidney disease. FDA officials say an advisory committee will be formed to re-evaluate the safety of all three drugs and possibly find solutions on how to control doses.

The safety risks of all three drugs were first revealed in 2007 after several clinical trials led to major safety concerns. The trials concluded that Epogen, Aranesp and Procrit were linked to heart attack and stroke, and may worsen the condition of cancer patients.

In the meantime, Amgen says the clinical trials are based on incomplete understanding of the use of anemia drugs.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s top personal injury attorneys who have tried a number of defective drug cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your rights as a consumer.

Amby Baby USA is conducting a voluntary recall across the United States of nearly 25,000 baby motion beds that have allegedly led to deaths of two infants this summer.

According to the Consumer Product Safety Commission (CPSC), the side-to-side motion of the hammock-like bed may prompt an infant to roll and suffocate after becoming trapped against the bed’s fabric and/or mattress.

The bed — sold online since 2003 — is marketed to parents nationwide whose babies may be fussy about going and/or staying asleep and suffer from colic or reflux. This is because the beds, made by Amby Baby USA, are designed to gently swing anytime a baby moves in its sleep, mimicing the motion that babies experience in the womb. The bed is recommended for babies who are less than nine months old.

The CPSC is urging parents to immediately discontinue using the bed and wait for a free repair kit, which according to the manufacturer, may not be provided until 2010. Parents who may have further questions are being asked to call 1(866) 544-9721.

The Florida lawyers of Aylstock, Witkin, Kreis and Overholtz are considered experts when it comes to personal injury and/or wrongful death cases. Contact the AWKO team at (888) 255-2956 who can inform you of your rights and help you with your claim.

Ten million Slim-Fast 11 ounce cans are being recalled nationwide. Unilever, the maker of the product, is currently cooperating with the Food and Drug Administration (FDA) to try and get the ready-to-drink, canned Slim-Fast drink off the shelves due to a possible bacterial contamination that has been linked with severe nausea, diarrhea and vomiting.

Slim-Fast meal replacement shakes, bars and packaged meals are dietary supplements designed to help people lose weight.

The FDA has launched an investigation of the company’s production facilities located in Covington, Tennessee following several consumer complaints. Unilever says it is pulling all its resources together in order to identify and correct the problem that may have led to the contamination.

Consumers are being asked to immediately discard any Slim-Fast canned products, regardless of the flavor and/or expiration date, and contact the company at 1 (800) 896-9479 to receive a full refund.

Unilever says the recall is a precautionary measure and does not apply to its other Slim-Fast products, as well as Skippy peanut butter and Ragu pasta sauce.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s premium personal injury attorneys who have tried a wide range of consumer safety cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your rights.

A recent study suggests that the popular drug Meridia (sibutramine hydrochloride) — used for the management of obesity and weight loss — may have caused a higher number of heart attacks and/or strokes than patients using a placebo pill.

Although, the Food and Drug Administration (FDA) is currently reviewing the data collected from the study, the agency has yet to announce any regulatory actions that may be taken as a result.

Meridia, a prescription drug, was first approved by the FDA in 1997, and has since been used to assist in weight loss maintenance in conjunction with a low calorie diet for patients who are extremely obese and may be faced with a number of health risks due to their obesity; including diabetes and high cholesterol levels.

Nearly 10,000 patients took part in the Meridia study. Participants ranged from 55 years and older, were overweight and had a history of heart disease, diabetes and an additional cardiovascular risk factor. Based on study results, it was concluded that Meridia increases the risk of heart attack, stroke and/or a number of cardiovascular conditions that could lead to death.

The FDA has announced that it is expediting the review process due to the severity of this new data and will inform the public of its actions — if any — as soon as possible.

In the meantime, the FDA is asking patients using Meridia to consult their health care provider to determine if continued use is right for them. In addition, the FDA is urging doctors and patients who are using this drug to report any side effects by calling 1(800) 332 – 1088.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are Florida’s top attorneys who have tried a number of drug safety cases. Contact the AWKO team at (888) 255 – 2956 to learn more about your rights as a consumer.

More than two million drop-side cribs made by Stork Craft, a crib manufacturer based in Canada, are being recalled due to suffocation danger to infants and toddlers.

The recall comes after a number of deaths and serious injuries have been linked to the drop-side cribs, which have a side that moves up and down and can easily be separated from one or more corners, trapping the child between the mattress and the side railing. According to the Consumer Product Safety Commission (CPSC), 110 incidents have occurred in the United States and Canada, resulting in the death of four babies between six and nine months old. Another 20 babies have fallen from their cribs after the drop-side detached completely.

The defect is being blamed on faulty hardware manufactured by Stork Craft, and assembly mistakes by the crib owners.

Parents are being urged to immediately stop using the drop-side cribs and contact Stork Craft to receive a free repair kit that will help convert the drop-side to a fixed side.

The recall involves more than one million cribs in the United States and another million in Canada. Stork Craft Cribs, manufactured for more than 15 years, is one of the most popular brand names in baby cribs, sold by some of the country’s biggest retailers.

In the wake of the massive crib recall, the CPSC is now considering banning all cribs that have a drop-side. However, this is not the first recall of baby cribs; another five million have been recalled over the past two years, about half a million of which also were manufactured by Stork Craft.

The lawyers of Aylstock, Witkin, Kreis and Overholtz are experienced personal injury attorneys adept at trying cases stemming from manufacturer neglect and product defect. Contact the AWKO team at (888) 255 – 2956 to learn more about your rights as a consumer.

For additional information, please visit the CPSC website.