Prilosec, Nexium analysis shows no heart disease link
ROCKVILLE, Md. The Food and Drug Administration on Monday affirmed that long-term use of either of the proton-pump inhibitors Prilosec or Nexium was not linked to any increase in the risk of heart disease.
However, the FDA continues to explore a potential increased risk of hip fractures associated with the use of PPIs, FDA officials told reporters this afternoon during a press conference.
“FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium,” the agency stated. “FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.”
The concern over a potential increased risk of heart disease and the use of these PPIs was raised earlier this year when AstraZeneca, manufacturer of both of these PPIs, reported a difference in the frequency of heart attacks and other heart-related problems out of earlier analyses of two small, long-term studies. FDA commissioned a formal safety review of the two drugs in August.
“FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems,” the agency stated. “FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.”
Allergan appoints Dawn Hudson to board
IRVINE, Calif. Allergan on Friday named Dawn Hudson to the company’s board, effective Jan. 28. Hudson is the former president and chief executive officer of Pepsi-Cola North America. In addition, Hudson served as chief executive officer of the PepsiCo foodservice division, which integrated the relevant units of PCNA and Frito-Lay North America with the Quaker, Tropicana and Gatorade brands.
“Hudson’s expertise and insights as a pioneer in brand development and consumer behavior will further strengthen Allergan’s leadership skills in consumer marketing,” stated David Pyott, Allergan’s chairman and chief executive officer. “Building on Allergan’s success record in developing and expanding markets, I am confident Ms. Hudson will add significant value in evaluating innovative practices and channels to help drive greater consumer awareness and appeal for Allergan’s core products.”
Hudson will initially serve as a member of the audit and finance committee and the organization and compensation committee.
Previously, Hudson served as vice chair of the American Beverage Association. She currently sits on the board of Lowe’s home improvement stores and is chairman of the Ladies Professional Golf Association.
Hi-Tech sales down due to cough-cold recalls
AMITYVILLE, N.Y. Early indications of the industrywide voluntary recall of children’s cough-cold medicines marketed for infants under the age of 2 are negative as it pertains to retail sales, as another cough-cold distributor pointed to the recall as a significant factor behind a companywide decline in sales.
For the three months ended Oct. 31, Hi-Tech Pharmacal reported net sales of $15.9 million, a decrease of 2 percent as compared with the same period last year. Sales for the healthcare products division, which markets the company’s OTC branded products, decreased 38 percent to $2.3 million, largely due to the discontinuation of the children’s formula of Diabetic Tussin at certain retailers.
“We believe the balance of the year will show growth as our core diabetic products continue to do well, and we prepare to introduce several exciting new products in the balance of the fiscal year,” stated Hi-Tech president and chief executive officer David Seltzer.
Last month, Prestige Brands reported its second-quarter results were negatively impacted in part by the voluntary removal of two kids cough-cold products under the Little Remedies banner.