NAD to DSE Healthcare Solutions: Modify ads for Cystex products
NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Wednesday recommended that DSE Healthcare Solutions, which markets both Cystex urinary pain relief tablets and Cystex liquid cranberry complex with Proantinox, modify its advertising to better distinguish the two products.
NAD, the advertising industry’s self-regulatory forum, reviewed the advertising claims at issue as part of its ongoing monitoring program and in conjunction with NAD’s initiative with the Council for Responsible Nutrition to expand NAD’s review of dietary-supplement claims.
NAD requested substantiation for claims that included:
“Cystex helps manage UTIs … and now promotes urinary health”;
“Cystex is the trusted urinary health brand that has helped millions of women manage the pain and discomfort of urinary tract infections”;
“If you are experiencing signs of a UTI, you can manage it with Cystex urinary pain relief tablets, the only over-the-counter urinary pain reliever available with a dual-action formula that not only eases the pain and burning caused by a urinary tract infection, but also contains an antibacterial (methenamine) to help the infection from getting worse while you wait for your doctor’s appointment”; and
“Cystex both manages the pain associated with a UTI and reduced [sic] the progression of the bacteria.”
NAD noted that it also was concerned that claims for the Cystex over-the-counter drug might be understood as applying to the Cystex liquid cranberry dietary supplement, since both products are featured in the same advertising.
The advertiser explained that it markets two separate Cystex products for urinary health: Cystex urinary pain relief tablets, an over-the-counter product, and Cystex liquid cranberry complex with Proantinox, a dietary supplement.
Key to NAD’s review was whether visitors to the Cystex website would interpret the claims made as applicable to both products. Further, NAD questioned whether the performance claims for the dietary supplement were supported by competent and reliable evidence.
NAD noted that the advertising at issue essentially includes three performance claims; that Cystex helps to “manage the symptoms” of urinary tract infections, prevent such infections and prevent existing infections from worsening.
In response to NAD’s concerns, the advertiser explained that the OTC product and the dietary supplement product are, in fact, different products, both designed to facilitate urinary tract health. DSE Healthcare contended that each product possessed its own scientific evidence in support of its claims, and that neither was dependent on the other to function as advertised. Further, DSE maintained that there is no specific link between the Cystex OTC drug and the dietary supplement product, other than the fact that they are both sold by the same company, under the Cystex name, and each has an impact on urinary tract health.
DSE Healthcare, however, acknowledged NAD’s concerns about this mixed message and represented that it would modify its website and take additional steps to make clear that it is selling two separate products. Further, DSE represented that it would modify any claims that suggest that the dietary supplement can manage or treat the symptoms associated with UTIs, NAD stated. NAD determined that the advertiser’s evidence could support the claims at issue as those claims are made for the OTC product. However, NAD recommended that the advertiser discontinue its claim that the Cystex dietary supplement “helps manage UTIs.”
Ruling: Illinois pharmacists can refuse to dispense Plan B
SPRINGFIELD, Ill. — Illinois Circuit Judge John Belz on Tuesday ruled that Illinois pharmacists could refuse to dispense the emergency contraceptive Plan B, despite a 2005 edict that required pharmacists to dispense Plan B, regardless of their religious beliefs, according to published reports.
The 2005 order issued by former Ill. Gov. Rod Blagojevich came at a time when a Food and Drug Administration decision to not allow Plan B to be sold over the counter became a hotly contested political debate. Plan B (levonorgestrel) and several generic equivalents are presently available for sale behind the pharmacy counter.
The state ruling affirms the Illinois Health Care Right of Conscience Act, which was passed in 1998 and protects healthcare providers from being sued for practicing according to their moral beliefs.
According to a USA Today report, Circuit Judge John Belz wrote that the 1998 law "was designed to forbid the government from doing what it aims to do here: coercing individuals or entities to provide healthcare services that violate their belief."
The state attorney general’s office will appeal the decision, reports stated.
FDA: Teething OTC drugs associated with risk of methemoglobinemia
SILVER SPRING, Md. — The Food and Drug Administration on Thursday posted a notification to healthcare professionals and patients that the agency continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products, which are available as a spray, gel and liquids sold over the counter. Benzocaine products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums.
The agency recommended that benzocaine products should not be used on children younger than 2 years of age, except under the advice and supervision of a healthcare professional. Adult consumers who use benzocaine gels or liquids to relieve pain in the mouth should follow the recommendations on the product label.
Methemoglobinemia is a rare but serious condition in which the amount of oxygen carried through the bloodstream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience such signs and symptoms as pale, gray or blue skin, lips and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate.
Methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, and cases mainly occurred in children ages 2 years or younger who were treated with benzocaine gel for teething. The signs and symptoms usually appear within minutes to hours of applying benzocaine and may occur with the first application of benzocaine or after additional use. The development of methemoglobinemia after treatment with benzocaine sprays may not be related to the amount applied. In many cases, methemoglobinemia was reported following the administration of a single benzocaine spray.
The FDA is continuing to evaluate the safety of benzocaine products and will update the public when it has additional information, the agency stated.