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: Misunderstanding of OTC cold product directions common
ELK GROVE VILLAGE, Ill. A study published Tuesday on the journal Pediatrics’ Web site determined that misunderstanding of dosage directions for pediatric over-the-counter cold products is common and could result in harm if medications are not given appropriately.
Researchers, however, used “old” kids cough-cold labeling as part of the study — labeling that advises parents to “consult a physician” in children under the age of 2. Today, kids’ cough-cold medicines advise parents to “not use” any cough-cold product in children under the age of 2; the industry voluntarily removed all products carrying the previous label recommendation from store shelves in fall 2007. And in January 2008, the Food and Drug Administration made it official — no kids’ cough-cold product could be marketed to children under the age of 2.
“While this study focuses on products that are not available, it does shine light on an issue that is still very germane,” commented Heinz Schneider, VP science and medical affairs, Consumer Healthcare Products Association. “In contrast to the artificial scenario created by the study authors who asked a small cohort of caregivers to look only at the front of product packages to determine appropriate use, the makers of OTC medicines want to remind parents to read the entire label before giving any medicine to a child. There is no substitute for reading and following the OTC Drug Facts label. The label provides specific dosing instructions, including when to contact a doctor for more information.”
Researchers interviewed 182 caregivers of infants of less than 1 year in age; 87% were the infants’ mother, the mean education level was 12.5 years and 99% had adequate literacy skills, though only 17% had greater than 9th-grade mathematical skills.
When examining the front of the product label, 86% of the time parents thought these products were appropriate for use in children less than 2 years of age. More than 50% of the time, parents stated they would give these OTC products to a 13-month-old child with cold symptoms. Caregivers were influenced by the dosing directions only 47% of the time.
WRatings Corp. reveals Colgate-Palmolive as top consumer goods co.
HERNDON, Va. The wRatings Corp., an independent stock research firm, last month revealed the results of the 2009 “Most Competitive Retail & Consumer Goods” study, finding that the recession has had a significant impact on consumer shopping behavior; 55% of the consumer-packaged goods companies among the top 20 rankings traded spots, with Colgate-Palmolive laying claim to the top spot.
“The competitive companies remaining in first quarter 2009 are on track to emerge from the recession with greater customer and economic strength than their rivals,” wRatings stated. “Various reasons exist for their durability, but most critical are access to real-time data along with the ability to transform your business faster than ever before.”
To arrive at the rankings, wRatings asked consumers how well companies meet their expectations every quarter. The consumer ratings are categorized by nine competitive moats, or barriers to entry companies create to protect against rivals taking their customers and, ultimately, their profits. Each W Score blends a company’s historical economic profit with its competitive moat scores.
Top 20 Most Competitive Consumer Goods Companies:
1. Colgate Toothpaste2. Mountain Dew/Diet MD3. Budweiser/Bud Light 4. Vaseline5. Kellogg Cereals6. Sam Adams/SA Light7. Weight Watchers8. Kleenex Tissue9. Clorox Products10. Gildan Activewear11. NIKE Products12. Marvel-Branded Products13. Coke/Diet Coke14. Crocs 15. Pepsi/Diet Pepsi16. Hormel Foods17t. Heelys17t. HNI Office Furniture 19. L’Oreal 20. Newport Cigarettes