The following table summarizes the important clinical manifestations (CM) from the 392 adverse experience reports possibly related to the use of Posilac® from February 1 through August 25, 1995.

This summary is intended only as a general reference to the type of reactions that veterinarians and dairy farmers have voluntarily reported to the manufacturer or FDA. Therefore, the summary is not by itself a basis for determining drug association for a particular sign, safety or efficacy of the drug, or determining the frequency or incidence rate of a clinical manifestation. Each of the reports may contain one or more CMs, and as a result the number of CMs exceeds the number of reports. It is important to recognize that all of the reported clinical manifestations are known to occur in dairy cattle not supplemented with Posilac®.

                                   

*   Includes udder swelling, udder edema, or abnormal milk.

** Includes decreased fertility, abortions, premature births, and retained placentas.

*** Includes anorexia, weight loss, and other digestive tract signs.

**** The most commonly reported CM for all dairy cattle drug products is death. This includes cows that were euthanized or slaughtered due to an illness, such as chronic mastitis.