FDA seeking to change acetaminophen dosage in OTC products
ROCKVILLE, Md. The Food and Drug Administration on Wednesday released recommendations it is considering in an effort to reduce adverse events associated with the popular pain reliever and fever reducer acetaminophen in advance of an advisory committee meeting being held in late June.
Included among those recommendations: require a warning that acetaminophen may cause liver damage in higher-than-recommended doses; limit the tablet strength for immediate-release formulations to a maximum of 325 mg and the single adult dose maximum of 650 mg; and eliminate combination products containing acetaminophen as one of the active ingredients.
Label changes would represent nominal cost to the industry, the FDA working group suggested, especially versus possible reformulation of existing products or the recall of combination products.
The FDA working group charged with reviewing the safety of over-the-counter and prescription acetaminophen briefly considered taking the ingredient off the market, noting precedents like the phenylpropanolamine recall in 2000.
“The reason not to take acetaminophen off the market is that it offers OTC pain relief without some of the risks of NSAIDs, particularly in long-term use,” the working group explained in its option paper, as opposed to PPA, which did have alternative products on the market with arguably safer profiles.
Instead, the group is proposing a lower dose as one of its recommendations.
“This approach — allowing the product to be available at a lesser daily dose — is consistent with adjusting the dose after some side effects for some populations become known after marketing,” the working group explained. However, while there is plenty precedent for the FDA requiring a reformulation of prescription-drug products, there is little precedent in the OTC arena, the group acknowledged. “Further legal research may be required to determine the appropriate method for requiring certain tablet strengths, as those are generally not specified by monographs.”
The working group also acknowledged that removing combination products containing acetaminophen from the market may be met with stiff resistance from both industry and consumer groups given both the cost of recall and lost sales, as well as the fact that current evidence has found that OTC combination products are responsible for a relatively small percentage of all acetaminophen overdoses.
“Acetaminophen is the most commonly used medication in the United States and provides safe and effective treatment for pain and fever to nearly 70 million American adults in a given week,” stated Linda Suydam, president of the Consumer Healthcare Products Association. “Because acetaminophen is so commonly used and prescribed, it is important to ensure that American consumers are aware that acetaminophen misuse or overdose can have serious health risks, including the risk of liver damage.”
The FDA is also recommending a concerted consumer education effort around the dangers of overdosing with acetaminophen, an effort that Suydam said industry would actively pursue.
“CHPA looks forward to working with the FDA and other interested parties to further build awareness among consumers about how to safely and effectively use acetaminophen,” she said.
CHPA reserved comment on the specific recommendations proposed by the FDA working group until after the June 29 advisory committee meeting on the subject.
Study finds stress, economy trigger digestive problems
MORRISTOWN, N.J. According to a recent Yankelovich survey released by Bayer Consumer Healthcare Wednesday, travel worries and the economy are triggering more concerns over stomach problems.
Close to half of all Americans at some time have had or worried about having stomach problems while on vacation, the survey revealed, and a majority of Americans have experienced increased stress because of the current state of the economy. Nearly 40% of those Americans report they now eat more comfort food, more snacks and more fast food due to their increased stress levels.
Taking a probiotic can help to eliminate that worry, Bayer noted, as probiotics have been shown to help address travel related issues like traveler’s diarrhea.
“Stress and poor diet are triggers that could potentially cause digestive problems,” stated Anish Sheth, assistant professor of medicine, Yale University School of Medicine. “Probiotics can be especially helpful when the digestive system is under stress from all sorts of issues ranging from occasional diarrhea or constipation.”
The survey also revealed that 1-in-4 Americans at some time have made up an excuse for why they’re going to the bathroom in the first place. Men in this group were just as likely to make up an excuse as women.
“Making excuses for bathroom habits could be a sign that something else is going on,” Sheth said. “Millions of Americans experience digestive problems, but few know that the key to digestive health is maintaining a balance between the ‘good’ and ‘bad’ bacteria in the colon, a vital part of the digestive system. But there are things consumers can do such as taking a probiotic to address digestive symptoms like constipation, diarrhea, gas and bloating, as well as overall colon health.”
Additional findings included:
- 10% of those surveyed spend 60 minutes or more in the bathroom a day;
- Women are only slightly more likely to make excuses for why they are going to the bathroom than men (26% for women compared with 24% for men);
- Women are more stressed because of the economy than men (60% of women versus 51% of men);
- And economic stress had a bigger impact on the eating habits of younger Americans than older Americans (61% of Americans between the ages of 18 and 24 say they eat more comfort food, more snacks and more fast food compared with 29% of Americans ages 55 to 64).
The survey was conducted by Yankelovich, a part of the Futures Company, on behalf of Phillips’ Colon Health Probiotic Supplement. Survey results were obtained through online interviews among a representative sample of 1,042 adults 18 and older.
Hyland’s launches improved teething gel
LOS ANGELES Hyland’s on Wednesday announced the launch of an improved Hyland’s Teething Gel — an all-natural teething gel that’s been endorsed by well-known pediatrician Jim Sears, one of the doctors featured on CBS’ “The Doctors” daytime talk-show.
“Hyland’s Teething Gel is the only all-natural, paraben-free teething gel on the market,” Sears stated. “This should assure parents even more that they are providing their children with the safest teething gel option, as opposed to products with active numbing agents.”
With no benzocaine, sugar, dyes, coloring agents, parabens or artificial flavoring, Hyland’s homeopathic formula includes chamomile, a popular and effective soothing ingredient for irritability. The medication comes in a tube that contains 50% more gel but at the same suggested retail price as its predecessor on shelf.
Hyland’s Teething Gel is now available in 0.5-oz. tubes in natural food stores nationwide. The product will launch in chain drug and mass market stores later this summer.