HEALTH

McNeil rebrands Advanced Imodium Multi-Symptom Relief

BY Michael Johnsen

FOR WASHINGTON, Pa. McNeil Consumer Healthcare on Thursday rebranded its Imodium Advanced Imodium Multi-Symptom Relief to better position the brand as the fastest anti-diarrheal medicine that also relieves symptoms of gas, cramps, bloating and pressure.

Imodium Multi-Symptom Relief combines loperamide hydrochloride with simethicone for relief of diarrhea, as well as the gas, cramps, bloating and pressure that nearly 65 percent of diarrhea sufferers can also experience. Loperamide HCl works in the small and large intestines by slowing the increased motility and reducing the increased secretion of fluid and electrolytes that occur with diarrhea. Simethicone acts in the stomach and intestines by altering the surface tension of gas and mucus bubbles, enabling them to group together. This action accelerates the passage of gas through the intestine.

Acute diarrhea is the second most commonly reported illness in the United States after respiratory infections. Diarrhea affects people of all ages, with the average adult suffering four bouts of acute diarrhea per year, and 22 million people reporting experiencing diarrhea at least once a month. Acute diarrhea also affects the travel plans of up to 10 million travelers each year.

Common causes of acute diarrhea include many medications, food intolerance, excessive caffeine or alcohol consumption and premenstrual syndrome.

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Discussion on children’s cough-cold medications remains ongoing

BY Michael Johnsen

WASHINGTON Pharmacy retailers can expect parents to be even more confused about what to give their sick kids this year during cold and flu season. This is in the wake of an FDA hearing Oct. 2 on the appropriate use of pediatric OTC cough-cold remedies, followed closely by a move among makers of these medicines to issue new package labels to alert parents that the products are not for use in children under four years old.Run the numbers and it leaves one huge hole in the market. According to 2007 U.S. Census Bureau estimates, there are 20.7 million children under age six. It is expected this group will suffer, on average, three to eight colds this year. That adds up to anywhere from 62.1 million to 165.6 million opportunities for pharmacy retailers to either help mom find an alternative remedy—e.g., supplements, humidifiers, topical menthol rubs—or let junior’s symptoms go untreated.

The Consumer Healthcare Products Association earlier this month announced that its members have initiated a voluntarily label change to advise parents that use of the medicines is not advisable in children under the age of 4. As this issue of Drug Store News went to press, many products featuring the new labels already had begun to ship to retailers.

Important to keep in mind, makers of these products insist, it is not the safety of these products themselves but how people use them that is really at the heart of the labeling changes. “Research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the leading causes of rare adverse events in young children,” explained Linda Suydam, president of CHPA. “As a result, the leading manufacturers of oral OTC pediatric cough and cold medicines are moving forward on both the design and implementation of initiatives aimed at encouraging the appropriate use of these medicines.”

In addition, CHPA manufacturers are voluntarily adding new language that warns parents not to use antihistamines to sedate or make their child sleepy, and the organization  also has expanded its national program to educate parents, caregivers, and healthcare professionals on the appropriate dosing and use of OTC medicines in children.

These moves came on the heels of the FDA’s January announcement banning kids OTC remedies for children under 2 years old. Apparently that  information remains top of mind for many consumers.

According to a June 2008 Survey.com poll of 606 parents conducted, 64 percent of all parents, including parents of children between the ages of five and 12, have made up their minds not to treat their children’s cold symptoms with traditional allopathic remedies. As many as 70 percent of parents with children under the age of 4 reported they had given their children cold medicine when they were sick in the past. That suggests that millions of parents will be looking for other options this cold and flu season.

That survey notwithstanding, one key concern shared both by OTC industry leaders and the Food and Drug Administration officials  is what parents might do as a result. One the plus side, Phillip Walson, retired professor of pediatrics and pharmacology at the University of Cincinnati, and an advisor to CHPA, cited studies suggesting that 40 percent of parents would seek an alternative, perhaps all natural, cough-cold remedy; on the alarming note, however, another 24 percent would attempt to calculate appropriate dosing for their kids from products labeled for adult use—in other words, take their best guess.

“We’re very concerned in seeing a shift of people using adult products [for their children],” commented John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, during the FDA’s Oct. 2 public meeting on the appropriate use of OTC pediatric cough/cold formulations.

Meanwhile, CHPA continues to back pediatric pharmacokinetic and efficacy studies on the seven most common monographed cough-cold ingredients. Together with pseudoephedrine, which already is backed by PK studies, those eight ingredients represent approximately 95 percent of the OTC products for children on the market, Suydam said.

Following the Oct. 2 meeting, FDA officials promised to take action—though exactly what action had yet to be determined, according to Jenkins. “This [public meeting is part of a] rulemaking process to get to a change in the monograph,” he said. Those closest to the situation have told Drug Store News it is unlikely that any action could occur any time before later in 2010 at the earliest, as any proposed change to the respective monographs would be followed by a comment period before any finalized rule change could be issued.

By that time, CHPA-conducted PK and efficacy studies could very well be complete, providing proof of the safety and efficacy of these medicines in a clinical setting versus the 30-plus years of anecdotal safety and efficacy experience that parents have relied upon in the past. And that could rewrite the rules for pediatric OTCs one more time before today’s kids are ready for their big-boy pants.

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Retailers reworking planograms in lieu of children’s cough-cold remedy debacle

BY Michael Johnsen

NEW YORK With the industry’s announcement that future labeling for kids cough-cold products would recommend use of those products in children only over the age of four, and that those products carrying the old labeling would sell through before being replaced with the new labeling, coupled with widespread criticism from Congress leaders and citizen advocacy groups that that voluntary measure doesn’t go far enough, purveyors of pediatric cough-cold remedies are in for another stormy season.

Last year, the Consumer Healthcare Products Association in October initiated a voluntary recall of all cold products marketed for use in infants—in other words, children under the age of two—just a few weeks before the Food and Drug Administration hosted a joint advisory meeting entertaining a citizen’s petition that would ban use of those cold products in all children under the age of six. From purely a business standpoint (to be clear, both CHPA and individual suppliers have repeatedly emphasized a focus on child safety in their advocacy of appropriate access to, and appropriate use of, these medicines, not profits), the timing couldn’t have been worse. October is oftentimes identified as the first month of the cough-cold season. Retailers at that time are about a month into the new season’s cough-cold planograms and suppliers begin advertising those cough-cold products in earnest. Compounding matters, the FDA in mid-January 2008 issued a public advisory against marketing cough-cold products for use in infants, which brought the issue again to top-of-mind among consumers just as actual cough-cold illness rates started picking up.

And while it’s difficult to ascertain just how much the timing of the actual under-two product recall, meetings and announcements impacted the actual business of pediatric cough-cold medicines, there has been an impact. Sales of kids cough-cold products dropped 8.5 percent to $287 million across food, drug and mass channels (minus Wal-Mart) for the 52 weeks ending Oct. 4, according to sales data from the Nielsen Company. That compares to a 12.1 percent lift in sales of adult cough/cold formulations sold over-the-counter, the lion’s share of which can be attributed to the crossover of McNeil’s Zyrtec from prescription to nonprescription, but still that suggests that the decline in kids cough-cold sales is more likely attributed to the confusion created by all those news stories questioning the safety and efficacy of these medicines as opposed to a mild cough-cold season.

Fast-forward to the 2008/2009 cough-cold season. Another October FDA meeting—this time a public meeting requesting comments on what changes should be made, if any, to the monographs governing the vast majority of these pediatric cough/cold products—threatens to scuttle sales of pediatric cough/cold medicines before the season really kicks off. CHPA, through negotiations with FDA, has volunteered to change label recommendations of cough/cold medicines to “do not use” in children under the age of four. FDA precedent surrounding voluntary label changes has allowed industry to allay the cost associated with replacing one label for another by selling through those products carrying the old labels. But the FDA is being pressured by some Congress leaders to act more aggressively regarding this label change—opening the door to the possibility that a second product recall in as many years may be forced upon the kids cough/cold industry.

The costs associated with removing those products out of the supply chain could run into the tens of millions across the industry, one supplier of those cough/cold products predicted, suggesting that any recall would result in millions of dollars in direct losses, as products are pulled off of shelves and out of the supply chain to be destroyed, for each manufacturer in the business, as well as for each retailer given the prevalence of private label offerings in the kids cold category.

Not all is doom and gloom, however. Several manufacturers are currently positioning their products as alternatives to appropriately relieve cold symptoms in younger children—products that will allay parent concerns over the use of allopathic medicines in their pre-school children and older and, if it actually comes to a product recall, will help fill that empty space created by the 100 or so SKUs that would be impacted by that recall.

Chief among those manufacturers are suppliers of homeopathic remedies. According to homeopathic suppliers, homeopathic cough, cold and flu medicines do not contain any of the ingredients under question for use in young children. The active ingredients are micro-doses of natural ingredients. And since homeopathic medicines are not body-mass dependent, there’s no need to give more or less medicine depending on body weight. There’s no risk of overdose, nor are there reported side effects such as making children jittery or drowsy. The medicines do not interact with other medications, herbs or supplements and do not “mask” symptoms that may indicate a more serious condition. Another positive—all homeopathic products are regulated as drugs by the FDA and are labeled for specific indications.

“Natural cough and cold medicines for children are not simply recent industry fads, but rather time-tested medications that are highly safe and effective,” stated Jim Sears, an expert in the field of pediatric medicine and advocate of natural medicines. “By being completely free of the active ingredients of concern to the FDA, homeopathic medicines provide symptom relief for children and peace of mind for parents everywhere.”

“It all comes down to understanding what you put into your body and the bodies of your children,” added J. P. Borneman, chairman and chief executive officer of Hyland’s. “At Hyland’s we create the types of children’s medications that we feel safe giving to our own kids. Our medicines treat the cause of sickness safely and gently, without fear of side effects, and are manufactured according to FDA’s Good Manufacturing Practices.”

Hyland’s launched a complete line of products to treat the cough and cold symptoms of children, including: Cough Syrup with 100 percent Natural Honey 4 Kids; Cold ‘n Cough 4 Kids, New; Cold Relief with Zinc 4 Kids Strips, due in stores this winter; Sniffles ‘n Sneezes 4 Kids; Complete Flu Care 4 Kids; C-Plus Cold Tablets; Cough Syrup with Honey; and Earache Drops.

“If parents take anything away from this situation, they should understand that they are their child’s greatest defense against avoiding the dangers associated with the OTC medications causing concern,” Sears said. “Parents need to make sure they are educated on the benefits of natural medicines available to them and their children so they are not forced to decide between treating their child’s sickness and keeping their child safe.”

Boiron this year has launched two new SKUs—Children’s Oscillococcinum for flu-like symptoms and Children’s Coldcalm Pellets for colds, which will be marketed alongside Boiron’s Children’s Chestal for coughs. “We created special packaging for Children’s Oscillococcinum and Children’s Coldcalm Pellets to make it easier for parents find these safe choices,” John Durkin, Boiron’s vice president, sales and marketing, said. “Now both products will be located in the children’s cough-cold and flu section and the packaging highlights important product benefits that will help parents treat their children’s symptoms—messages like ‘safe, no side effects, great taste, and easy to take,’” he said. “We’ve also modify the delivery method of our regular Coldcalm tablets so the children’s version of it and Oscillococcinum come in sweet-tasting kid-friendly pellets.”

Other treatment alternatives include drug-free devices that help increase a child’s air flow naturally, such as GlaxoSmithKline’s Breathe Right Kids, and devices such as Kaz’s Vicks-branded humidifiers. 

Additionally, a recent study in healthy children found that Breathe Right Kids nasal strips help children breathe better by improving airflow when lying down to go to sleep. Findings also indicated that the strips are well-tolerated by children, comfortable to wear and easy to remove.

“Other simple drug-free remedies such as humidifiers or vaporizers, and Breathe Right Kids nasal strips all stand to provide nasal congestion relief while giving parents an alternative to over-the-counter cold medications for nasal congestion,” commented Jennifer Shu, co-author of parenting books published by the American Academy of Pediatrics.

The Mayo Clinic recommends using a humidifier to maintain daily moisture levels at 40 to 50 percent in the home. When children are suffering from a cold or cough, a higher humidity level will often increase their comfort and help ease congestion. Vicks offers a number of humidifiers to help parents and kids get through this cold season, the company stated in a recent press release issued soon after the latest FDA meeting.

Other alternatives include dietary supplements that can help boost immunity health, as well as help improve the function of healthy sinus and respiratory in children. Bionorica this year introduced its Sinupret for Kids syrup, a plant-based product supported by substantial clinical trials for its appropriate use in children.

Sinupret is also one of the first dietary supplements to partner with the venerable Walt Disney Company, a family entertainment company known for zealously guarding their brand image, according to Scott Bukow,  Bionorica president. Bukow said that his company will be distributing free samples of Sinupret at several Disney on Ice events this season.

Sinupret for Kids syrup promotes healthy drainage in the upper respiratory tract, improves airflow in the nose and supports healthy mucous clearance from the nose and sinuses.

Sinupret is cited as safe and effective in numerous peer reviews, scientific and medical journals, including American Botanical Council Clinical Guide to Herbs, Journal of Clinical Pharmacology, Phytopharmaka, Planta Medica, Natural Standards-Herbs, Pharmacist’s Letter for efficacy and safety and Natural Medicines Comprehensive Database.   

Even manufacturers of traditional allopathic medicines are introducing new products into a risk-averse kids cough/cold environment. The Quigley Corporation recently introduced its new Kids-EEZE Chest Relief, a single-ingredient, allopathic expectorant with guaifenesin to help children, ages six and up, suffering from uncomfortable chest congestion. Quigley is positioning the product containing guaifenesin, which is actually one of the ingredients the safety and efficacy of which is being questioned in young children, as a single ingredient alternative to the many multi-symptom children’s cold products that could potentially lead to overmedication, the company stated.

“In recent years, the cough and cold remedy category has seen a growth in multi-symptom cold remedies, which has led to concerns about parents overmedicating their kids and treating symptoms their children weren’t actually suffering from,” said Albert Piechotta, executive director of communications and investor relations at the Quigley Corporation. “Chest congestion is a typical symptom of the common cold and one that is uncomfortable for children,” Paul Horowitz of Discovery Pediatrics in Valencia, Calif. said. “Making a cough more productive can really make the child feel better and reduce the chances of that chest congestion turning into something more serious.”

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