We at Merck Animal Health pride ourselves on being a responsible company that puts animals and consumers first. The benefits and safety of Zilmax® (zilpaterol hydrochloride) are well documented and the product has a 30+ year history of research and development and rigorous testing. Worldwide regulatory agencies have reviewed extensive data on Zilmax and have concluded that use of Zilmax, according to the label, is safe in cattle. It is important to understand these data included rigorous animal health safety and well-being studies - conducted by university experts - that found the behavior and movement of cattle fed Zilmax is normal.
It is Merck Animal Health's policy to vigorously pursue all reported adverse events whether or not they are deemed related to the product. It is a responsibility we take very seriously. We are confident in the totality of our data and the safety of the product and the well-being of the animals that receive it.
In response to recent questions about Zilmax, we're announcing our Five-Step Approach to Ensuring Responsible Beef and educating our customers and interested groups who are involved in animal husbandry and well-being.
1. Merck Animal Health is committed to re-certifying every feeder/nutritionist/veterinarian that feeds Zilmax to cattle. The re-certification process will begin immediately. Special attention will be given to feed mixing and determining which cattle are good candidates for the use of beta-agonists. We will engage third party experts to provide periodic review of certifications.
2. Within the next 30 days, Merck Animal Health is committed to reaching out to packers and suppliers to initiate a scientific audit, which will focus on the feeding of Zilmax, and will follow those cattle from the feedyard to the packing plant to determine potential causes of lameness and other mobility issues during feeding, transportation, offloading and staging at the processing facility. Merck Animal Health will do a thorough review of potential compounding factors-such as nutrition, transportation, receiving facilities, etc. We will perform this audit in conjunction with third-party experts.
3. Based on our findings, Merck Animal Health is committed to reinforcing appropriate management practices for feeder customers to include overall nutrition and feeding objectives, animal handling, low-stress environments and transportation.
4. Continuing in our work to advance animal well-being, we will form the Merck Animal Health Advisory Board within the next 30 days, made up of representatives from small, medium and large feeders, packers, cow-calf operators, as well as animal health and nutrition experts, to review available data. If additional recommended management practices are needed, these will be identified, shared and promptly implemented.
5. Merck Animal Health takes our responsibility very seriously and is committed to sharing all of these findings and to be transparent.
Zilmax has a withdrawal period 3 days prior to harvest. Not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves. For complete safety information, refer to product label and Zilmax website.
About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2012 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).