Tylenol (J&J):  Tylenol suffered a series of missteps, bad press and problems over 2009 that challenged the brand's long standing equity of safe use.  These included:  1) an FDA study group confirming the liver toxicity of acetaminophen as a concern; 2) the FDA acting to downsize the dosing instructions for acetaminophen including some combination products to avoid overdose;  3) bacterial contamination of a Tylenol product indicated for children; 4) chemical contamination of a Tylenol product indicated for the elderly; 5) a clinical trial demonstrating that acetaminophen dosing prior to vaccination of infants interferes with their immune response; and, 6)  a clinical review claiming that acetaminophen increases asthma risk by 1.6 times.  Much of this erosion can be attributed to a growing awareness of the drug's vulnerabilities versus its real world use, brand positioning and safety halo.

Zicam (Matrixx):  Well into the summer of 2009 the US FDA has created yet another wave of fear and concern about the common cold, or more precisely its treatment with Zicam Nasal Gel [www.zicam.com].  In a formal warning letter issued June 16th the FDA blindsided the maker of Zicam, Matrixx Initiatives, with the threat of seizure, or other actions aimed at removing these "unsafe" nasal zinc products from the consumer market.  The FDA claimed 130 consumers reported loss of smell after use and that Matrixx was rumored to have 800 more reports that they need to divulge.  This all seems odd.  Zicam has been sold in the consumer market in the product forms in question since 1999.  Zicam contains a simple zinc salt not a new chemical entity.  Zinc salts have been alleged for years to be anti-viral agents against certain colds viruses, a fact sometimes shown in the lab and clinic, but are subject to continuing controversy in the medical and regulatory communities.

Prevacid (Novartis):  In mid-November 2009 Novartis  launched Prevacid  as the second branded switch entry in the OTC gastric acid space (after Prilosec, P&G).  The full impact of this launch will play out in 2010 in an increasingly competitive space as new entries, such as Zegerid (Schering), arrive.  These will all compete directly or indirectly with cheaper store brands already in place.

Alli (Glaxo):  In late August 2009 rare reports of liver injury surfaced related to the use of Alli (orlistat, OTC).  The FDA is conducting a safety review while the product remains on the market.

Purell (J&J)/Germ-X (Vi-Jon):  Hand sanitizers made a big splash due to the great H1N1 panic of2009.  If this flu promotes good public health habits, as it seems to have done, this will contribute to sustained sales in 2010.  OTCPN picked Germ-X as the best price/value of the group.
 
[Donald Kay Riker, Ph.D. is President & Founder, On Point Advisors, a consumer healthcare consultancy founded in 2007 and Editor-in-Chief, OTC Product News.  Dr. Riker spent 25 as a senior manager in the consumer drug industry.  He was Chattem's last Vice President of R&D & Chief Scientific Officer]