True Man and Energy Max Dietary Supplements are dangerous and defective products.? The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.? FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as “all natural” alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.
“These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products,” said Steven Galson, M.D., MPH, director of the FDA’s Center for Drug Evaluation and Research.”The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”
The undeclared analog ingredients in True Man and Energy Max 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.
FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.
True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.
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The US Consumer Product Safety Commission and the National Highway Traffic Safety Administration (NHTSA), in cooperation with Evenflo Company Inc, announced a recall Friday of the Evenflo Embrace? Infant Car Seat/Carriers.?? The recall affects about 450,000 infant car seats.
The manufacturer of the defective car seats is?Evenflo Company Inc., of Vandalia, Ohio
When used as an infant carrier, the handle can unexpectedly release, causing the seat to rotate forward. When this happens, an infant inside the carrier can fall to the ground and suffer serious injuries.? There have been 679 reports of the handle on the car seat unexpectedly releasing.? This defect has caused 160 injuries to children.? These injuries include a skull fracture, concussions and lacerations.
The recall involves Evenflo Embrace? Infant Car Seat/Carriers made before April 8, 2006. The recalled car seat/carriers have model numbers beginning with 317, 320, 397, 398, 540, 548, 549, 550, 556, 597, 598 or 599. The model number and production date information can be found on a white label on the bottom of the carrier and on the top of the convenience base. Models beginning with ?5? are units sold with the travel system (compatible stroller). ?Evenflo? is on the carrying handle and car seat base. Embrace? infant car seat/carriers made on or after April 8, 2006 are not included in this recall.??Hopefully the recall will prevent future injuries to children as a result of the product defect.? If you believe that your child has been injured by the defective car seat, make sure that you keep the defective car seat.? It is vital evidence to prove that the car seat was indeed defective and the defect was a substantial contributing factor in causing your child’s injuires.? Contact one of our Connecticut personal injury lawyers should you have any questions relating to this defective child car seat.
Ortho Evra is the first transdermal (skin) patch approved for birth control. The weekly prescription patch releases norelgestromin (a progestin hormone), and ethinyl estradiol (an estrogen hormone), through the skin into the blood stream to prevent pregnancy. The U.S. Food and Drug Administration approved Ortho Evra, manufactured by Ortho McNeil, a subsidiary of Johnson & Johnson, in November 2001.
Ortho Evra, an alternative to birth control pills, is a one-and-three-quarter inch square patch consisting of three layers. The hormones are embedded in the adhesive layer and are slowly released when the patch is applied to the skin.
According to the FDA, women who choose to use the product should apply it to the lower abdomen, buttocks or upper body but not to the breasts. Each patch should be worn continuously for one week and should then be replaced with a new patch on the same day of the week for a total of three weeks of patch wear.
The fourth week, which is patch-free, allows a woman to have her menstrual period – similar to the regimen for birth control pills.
Like birth control pills, Ortho Evra is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to the risks of using birth control pills including an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.
In April 2004, an 18-year-old New York fashion student died while using the Ortho Evra patch. According to officials for the FDA and Ortho McNeil, the death is the first linked to the contraceptive patch. Information from the Medical Examiner’s Office indicates Zakiya Kennedy’s death was caused by a blood clot.
In November 2005, Ortho McNeil issued a warning to millions of women revealing that the patch exposes them to significant amounts of estrogen and may put them at greater risk of developing blood clots.
Based on an internal company memo, Ortho McNeil refused to fund a study which would have compared the Ortho Evra patch to the company’s Ortho-Cyclen birth control pill. The company was afraid that the results of such a study may not be positive for the patch. However, the company now states that it plans to conduct a study for the patch, similar to studies previously conducted with the Pill. The Ortho Evra website states that prior to marketing the patch, it had been studied on over 3,000 women.
See your doctor if you have experienced serious health problems after using the Ortho Evra patch.
The maker of the widely used Ortho Evra birth control patch, Johnson & Johnson, is trying to prevent negative attention over its dangerous contraceptive by purchasing the rights to domain names like Orthoevrakills.com and Deathbypatch.com.
In late 2005 when the Food and Drug Administration urged that a heightened warning alerting users to the risk of potentially fatal blood clot and stroke be added to the drug’s label. In February 2006, a study showed that women using the Ortho Evra birth control patch faced double the risk of blood clots than women who use oral contraceptives. The increased risk is due to the fact that the patch exposes users to higher levels of hormones–60 percent more–than oral medications.
Johnson & Johnson purchased and registered the domain names but is not using them. The move was strictly an attempt to preempt critics of Ortho Evra from attracting negative attention to the dangerous drug.