Articles Tagged with injury

Washington residents who take dietary supplements should be aware of a consumer warning issued by the Food and Drug Administration on April 13 about a product called Tri-Methyl Xtreme. Three injuries were reported by consumers in Utah, New Jersey and California, and there is concern that the product said to contain anabolic steroids could cause liver damage.

Tri-Methyl Xtreme is distributed by a Las Vegas company called Extreme Products Group, and the supplement is marketed as a way to help build muscle and sold in some gyms and retail stores as well as online. The company claims that anabolic steroids are found in the supplements, and an FDA scientist said that anabolic steroids can cause serious and irreversible damage to multiple organs in the body. In addition to liver damage, synthetic steroids could also cause increased risk for strokes and heart attacks. Consumers should watch for ill effects like discolored urine, back or abdominal pain or unexplained fatigue

Dietary supplements cannot possess steroids or any prescription drug ingredients, but manufacturers are in charge of regulating their own products and making sure they are safe because supplements are not required to go through FDA effectiveness and safety reviews. The FDA often issues warnings when supplements are found with drugs that can be used to aid body building, sexual enhancement or weight loss.

Washington residents may be interested to learn that Graco, a major manufacturer of car seats, was hit with a $10 million fine for delaying the issuance of a recall for defective child car seats, potentially placing millions of children in danger. The fine follows the conclusion of the company’s completing the largest car seat recall in U.S. history.

According to the National Highway Safety Administration, the first $3 million is due from the company immediately. The remaining $7 million must either be paid in over the next five years or the company must spend an equal amount on safety improvements. The recall involved four million child and booster seats and two million rear-facing infant carrier seats, all of which had defective safety buckles.

Reportedly, the company had delayed the recall despite numerous parent complaints about defective safety buckles on the car seats. The recall was not conducted until NHTSA pressured the company into proceeding with it. A part of what the company will be required to do is come up with a strategy to encourage the return of a greater percentage of recalled seats. Although 75 percent of recalled vehicles are subsequently repaired, the agency indicated only 40 percent of the defective car seats have been.

Children’s Tylenol maker McNeil Consumer Healthcare pleaded guilty recently to a federal criminal charge that the company knowingly sold infants’ and children’s medicine containing metal particles. The Johnson & Johnson subsidiary admitted that it was aware of the manufacturing problem for almost a year before taking corrective action. This latest Tylenol case calls to mind the drug recalls and scares of the 1980’s, which included lethal tampering with Tylenol and later copycat tampering with Excedrin in Washington.

In this case, McNeil acknowledged that particles of nickel, iron, and chromium were introduced into liquid infants’ and children’s Tylenol and children’s Motrin during manufacturing at their plant near Philadelphia. Although the particles did not cause injury, the FDA advised families to stop using adulterated medicines.

An attorney for McNeil acknowledged that although the company launched an initial investigation of the problem after a consumer reported it in 2009, it did not follow through on all of the steps required in its own internal guidelines. The plant, which was linked to other Tylenol recalls, was closed in 2010 and completely rebuilt, though it has not yet reopened. Department of Justice prosecutors faulted McNeil for not following good manufacturing practices and promised continued aggressive oversight and punishment of any companies that disregard these practices and safeguards, particularly when the health of children is at stake.

Motorists in Washington may be interested in a letter sent by the National Highway Traffic Safety Administration to a manufacturer on Oct. 29. So far, two deaths have been attributed to defective airbags manufactured by Takata, an automotive supplier. In the letter, NHTSA officials issue orders and inquire about the company’s ability to expedite the current recall involving airbags in 7.78 million vehicles. The NHTSA has already contacted auto manufacturers and expressed interest in enlisting other suppliers to expedite the process.

The pace of the recall depends on having enough replacement parts available. There have been reports of defective airbags propelling metal and plastic shrapnel at passengers as they deploy during a collision. In the letter, the NHTSA Deputy Administrator inquires about the number of replacement canisters Takata can produce, how much the rate of production can be increased and the quality of controls in place. The NHTSA also ordered Takata to improve their testing procedures for identifying defective airbags.

The NHTSA has already requested that auto manufacturers expedite their own recall notification campaigns. The NHTSA is requesting these manufactures develop innovative strategies for getting their customers to bring their vehicles into local dealers to get the defective airbag component replaced.