Tylenol to revise dosing instructions for extra-strength product
FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).
"Acetaminophen is safe when used as directed," McNeil Consumer VP OTC medical affairs and clinical research Edwin Kuffner said. "But, when too much is taken … it can cause liver damage. Some people accidentally exceed the recommended dose when taking multiple products at the same time, often without realizing they contain acetaminophen or by not reading and following the dosing instructions."
McNeil has informed the Food and Drug Administration that the new dosing instructions will appear on Extra Strength Tylenol product packages in the United States beginning in fall 2011.
McNeil also will be lowering the maximum daily dose for regular strength Tylenol and other adult acetaminophen-containing products beginning in 2012.
In addition to the new dosing instructions on the OTC label, McNeil recently launched Get Relief Responsibly, a national initiative designed to educate consumers about the appropriate use of prescription and OTC medications, particularly those containing acetaminophen, and the importance of reading and following medication labels. As a part of this initiative, the Tylenol website has been enhanced to include interactive tools to help consumers identify products that contain acetaminophen.
McNeil also announced that it will be introducing bottle cap messaging on select Extra Strength Tylenol products. The bottle cap messaging is a message printed directly on bottle caps to remind consumers to always read and follow the label instructions. This messaging is planned to appear on select Extra Strength Tylenol caps starting in 2012.
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Bill seeks to eliminate ‘use it or lose it’ provision in FSAs
WASHINGTON — Sens. Ben Cardin, D-Md., and Mike Enzi, R-Wyo., last week introduced the Medical Flexible Spending Account Improvement Act (S. 1404), a bill that would allow consumers to pay taxes on and withdraw any remaining funds in their employer-sponsored flexible spending accounts.
Current rules require that any leftover balance in an FSA must be forfeited to the employer at the end of the plan year, oftentimes identified as the "use it or lose it" provision.
The bill is the Senate counterpart to H.R. 1004, which was introduced with bipartisan support in March by Reps. Charles Boustany, R-La., and John Larson, D-Conn.
“It is time to modernize FSAs to eliminate this burdensome ‘use it or lose it’ rule," Cardin said. "It is both fair and sound health policy to allow FSA participants to cash-out remaining funds at the end of the plan year rather than forfeiting the balance to their employer.”
Save Flexible Spending Plans, an advocacy group that hopes to make FSAs more accessible to consumers, commended Sens. Cardin and Enzi for their introduction of the bill.
“FSAs help millions of Americans manage and reduce their out-of-pocket healthcare costs,” said Joe Jackson, chairman of Save Flexible Spending Plans and CEO of benefits administration service provider WageWorks. “However, the ‘use it or lose it’ rule creates an unnecessary risk for FSA participants and a deterrent for nonparticipants. Changing this rule will ensure that participants don’t lose their hard-earned money if their out-of-pocket healthcare costs don’t match their prediction for the year.”
In addition, the bill’s sponsors noted that the original reason for adopting the “use it or lose it” provision is no longer relevant. The IRS adopted the provision to prevent FSAs from being misused as tax shelters. But according to Sen. Cardin, “with the enactment of the Patient Protection and Affordable Care Act in 2010, annual contributions to FSAs will be capped at $2,500 beginning in 2013, which makes the ‘use it or lose it’ rule unnecessary.”
As healthcare consumers and American stakeholders affected by 16%+ GDP healthcare expenses dramatically draining our country’s economic strength, we should all drive support of the bill for the FSA Improvement Act. The Act removes significant disincentives to the adoption of money-saving tools by allowing participants to withdraw non-used funds at the end of each year. The FSA Improvement Act is at the core of consumer driven health care (CDHC). CDHC intuitively helps control costs as patients become true stakeholders and are fiscally, emotionally, and physically engaged in the choices, decisions and outcomes. On the objective side, a McKinsey study found that CDHC patients were twice as likely as patients in traditional plans to ask about cost and three times as likely to choose a less expensive treatment option. Further, it reported that chronic patients were 20 percent more likely to follow treatment regimes carefully. Now this is progress! Thankfully, CDHC is alive and present and, in order to reduce costs and improve overall ROI on health care, we need to strongly encourage any programs, including legislative, which promote, incent, and reward CDHC.
Study finds most smokers lack knowledge on ways to quit smoking
PARSIPPANY, N.J. — Almost half of all smokers try and fail to quit their addiction to nicotine products each year, according to a study released Wednesday.
A contributing factor to the high rate of failed quit attempts is the low use of nicotine-replacement therapies, the study found. That may be because of misperceptions around the health effects of NRTs.
The study, which was fielded in partnership by GlaxoSmithKline Consumer Healthcare and Legacy, reported that 93% of smokers did not know smoking while wearing the nicotine patch does not cause heart attacks; 76% of smokers did not know nicotine patch, gum and lozenge products are not as addictive as cigarettes; and 69% of smokers did not know NRT products are not as harmful as cigarettes.
"The data indicate a need to further inform smokers about the methods that can effectively help them quit," stated Saul Shiffman, researcher on the study, professor in the departments of psychology and pharmaceutical science at the University of Pittsburgh and senior scientific adviser at Pinney Associates, which provides consulting services to GSK. "Of particular note, 84% of respondents requested feedback on their incorrect answers in the survey, suggesting smokers want information regarding quitting and are interested in learning about the safety and efficacy of cessation strategies."
Findings from the study were published in a recent issue of the journal Addictive Behaviors.
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