FDA Panel Decides Acetaminophen Doses Should Be Changed

Greg Webb — Tue, 30 Jun 2009 22:07:43 GMT

On Tuesday, June 30, 2009, thirty-nine government safety experts, who were assembled by the Food and Drug Administration (FDA), recommended ways to reduce deadly overdoses of acetaminophen, which is the leading cause of liver failure in the United States. This liver failure sends about 56,000 people into the emergency room causing about 200 deaths each year. Due to these staggering numbers, the panel called for sweeping safety restrictions on the most widely used painkillers, including decreasing the maximum dose of Extra Strength Tylenol from eight pills of medication to a not yet determined amount and endorsed limiting the maximum single dose from 1,000 mg, or two tablets, to 650 mg; the 1,000 mg dosage should only be available by prescription.

The panel also narrowly voted to eliminate prescription drugs that combine painkilling ingredients with acetaminophen, such as Percocet and Vicodin, citing sixty percent of acetaminophen-related deaths are related to the prescription products. Some panel members, however, disagreed with this decision because so many Americans deal with chronic pain and depend on the medications. If these drugs stay on the market, members of the panel ask that the drugs’ label carry a black box warning, which is the most serious safety label available.

Drug companies avoided the most damaging potential outcome after the panel decided that over-the-counter cold medications, such as Nyquil and Theraflu, which combine other drugs with acetaminophen, could stay on the market. Though these drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, the FDA claims they only cause about ten percent of the acetaminophen-related deaths.

Although the FDA is not required to follow the advice of its panels, it usually does. Many doctors believe this is the opportunity to save a lot of people from inadvertent overdoses. For example, college sophomore Madalyn Byrne died after taking eight Tylenol a day for a week due to a toothache. Madalyn’s mother believes that had the bottle said to take four tablets a day instead of eight, her daughter would still be alive.

Originally posted at InjuryBoard by Greg Webb

Additional Crib Dangers May Not be Addressed by Recent Recalls

Greg Webb — Sun, 30 Nov 2008 20:23:36 GMT

In October, the Consumer Product Safety Commission (CPSC) issued a recall on 1.6 million Delta Enterprise Corp. cribs, but those cribs that had been fixed by the recall may not be safe after all. The Chicago Tribune reviewed government documents and found another 19 instances of hazards on the Delta cribs, all of which were different from those affected by the recall.

Cribs have turned out to be one of the most deadly nursery products, though they are designed for a baby to be left unattended for hours at a time. One small missing or broken part could lead to injury or death. In the 1970s and 80s, two fixes helped reduce the number of deaths from cribs: lessening the distance between side slats, and removing corner posts that could snag babies’ clothing, leading to strangulation. The problems with cribs today come from both the complexity of cribs and the shift to manufacturing cribs abroad. Many cribs make the transition from cribs to toddler beds to adult beds, which may add convenience but also involves more moving parts which can become worn down or lost. In addition, manufacturing cribs overseas has resulted in low or no quality control at those facilities.

A major problem with crib assembly is inadequate instructions and designs that allow parents to inadvertently assemble the product in dangerous ways. CPSC engineer Patty Hackett said “Some of the instructions are worthless. I’ve seen cribs mis-assembled and still operate. That’s what scares me.” One example is the Delta Athens crib, which allows parents to install the stabilizer bar upside down but still function. The stabilizer bar holds the crib together and supports the mattress platform. The Myhra family experienced a frightening incident with their Delta Athens crib when nine-month old Sabrina began crying from her crib, and mother Cari walked in to find one end of the crib mattress had fallen to the floor and Sabrina clinging to the crib sheet to avoid getting trapped between the mattress and the crib frame. Their crib’s stabilizer bar had been installed upside down, but the crib looked normal with the bar that way.

The mattress problem is not an isolated incident. Delta is aware of complaints about its mattress supports and is working with the CPSC on the issue. Their company position is that “when properly assembled, the cribs are absolutely safe,” said spokesman Jack Gutt. However, commission records show that the mattress problem is not solely caused by incorrect assembly. In 2002, the bottom of a one-year-old boy’s Delta Luv crib collapsed, which was caused by a wood joint that failed “possibly caused by the lack of sufficient glue.” In 2004, a two-year-old girl was trapped after a rivet on the mattress support failed. Luckily both children survived. These are just a few of many incidents, according to CPSC reports.

The CPSC staff has challenged the regulatory system instituted under President Reagan, which forces them to defer to voluntary standards that are controlled by manufacturers. They urged commissioners to bypass the process and move toward federally mandated safety regulations because the current standards “are inadequate to prevent entrapment deaths and injuries of young children.” Earlier this month, commissioners agreed.

Consumer demand for convenience and low prices have prompted companies to look to overseas factories for cheaper materials and labor. However, this choice may sacrifice quality and safety. Rachel Weintraub, director of product safety at the Consumer Federation of America, asked, “Is the quest to produce lower-cost cribs leading to a sacrifice on the quality of the wood and other parts? They are making their product overseas, so they’re getting the benefit, but they’re not taking additional measures to deal with increased risk.”

Originally posted at InjuryBoard by Greg Webb

Charlottesville Personal Injury Lawyer - Deadly

FDA Panel Decides Acetaminophen Doses Should Be Changed

Additional Crib Dangers May Not be Addressed by Recent Recalls