Pigs rank first in number of adverse reactions after taking Paylean

The figures used in our report come from the 2011 March Cumulative Veterinary Adverse Drug Experience (ADE) summary report published on the website of the Center for Veterinary Medicine (CVM) of the U.S. Food and Drug Administration (FDA). Please click to see the enlarged image!

Helena Bottemiller pointed out that if you browse through the English names of animal drugs approved for marketing by the U.S. Food and Drug Administration from A to Z, you will find that among the statistics on adverse reactions in pigs from taking animal drugs, ractopamine ranks first, reaching 218,116 cases. Next is Tylosin, which caused 32,738 adverse reactions in pigs.

In addition, 2,143 pigs were also reported for adverse reactions after taking a combination drug of ractopamine and Tylosin. The combination drug of ractopamine and tylosin is used as an antibiotic for pigs and cattle. The top 10 most commonly reported symptoms are: Lameness, Vocalization, Biting/chewing, Death, Hoof Disorder, Locomotion Disorder, Pain, Recumbency, Reluctant To Move, Shaking.

In the "Cumulative Veterinary Adverse Drug Experience" document records reviewed by Helena Bottemiller, many reactions are complaints from pig farmers using Paylean, for example as follows:

"In May 2008, an internal sales assistant at Elanco Animal reported back on the adverse reactions caused by pigs using Paylean. Around May 9, 2008, Iowa pig farmer Ms Dyer began adding Paylean to her pigs' feed at a level of 4.5 grams per ton (4.5G/TON). By May 23, 2008, 2 pigs had died, and on May 27, 2008, other pigs also died. Ms Dyer reported that the pigs developed pink spots on their bodies and then died, yet pathological examination of the gastrointestinal tracts of the dead pigs showed no abnormalities. At the same time as the examination report was being made, pink spots also began to appear on the skin of Ms Dyer's other pigs. Ms Dyer immediately isolated these pigs and stopped adding Paylean to the feed."

"Ms Dyer believed that Paylean was the cause of the pink spots and deaths in the pigs. She also explained that she had been adding Paylean to pig feed for several years and had always found many problems (no specifics provided). However, Ms Dyer still continued to add Paylean to the feed."

"According to information updated on June 3, 2008, Ms Dyer began feeding pigs Paylean at 6.5 grams per ton (6.5G/TON) on May 24, 2008, resulting in a total of 8 pigs developing bruising and dying, and she also reported that after taking Paylean, the pigs showed ACT CRAZY, HUDDLE TOGETHER, STRESS EASILY." (See: Center for Veterinary Medicine Adverse Drug Experience Reports, pages 252-253)

However, Helena Bottemiller also pointed out that although the quality and content of the "Cumulative Veterinary Adverse Drug Experience" report published on the website of the U.S. Food and Drug Administration's Center for Veterinary Medicine vary unevenly, it is still the only source available for understanding the use of ractopamine. For example, farmers may call to complain that pigs are becoming increasingly hyperactive and lame after taking ractopamine, but they do not provide specific detailed numbers for the affected pigs, and it is also unclear whether it was caused by taking ractopamine.

Therefore, through the U.S. Freedom of Information Act, Helena Bottemiller requested that the U.S. Food and Drug Administration provide more detailed content. In April 2011, the U.S. Food and Drug Administration released a 464-page "Cumulative Veterinary Adverse Drug Experience" report, which detailed the reported adverse reactions from the use of ractopamine in turkeys, cattle and pigs. After these three types of poultry and livestock were fed ractopamine, in addition to 218,116 reports of adverse reactions in pigs, there were also 9,340 in cattle and 183,005 in turkeys.

In Helena Bottemiller's article, it was also mentioned that three years after the U.S. Food and Drug Administration approved Paylean for marketing in 1999, it required the drugmaker Elanco in 2002 to add a warning label for Paylean. The warning label read: "Note: During the process of raising pigs for market, ractopamine may increase the number of injured or fatigued pigs. It is not recommended for use in breeding pigs."

Regarding Helena Bottemiller's article, Hsu Tien-lai, Director-General of the Bureau of Animal and Plant Health Inspection and Quarantine of the Council of Agriculture, said that after the representative office in the United States asked the U.S. FDA, an initial response was received last Friday, stating that the number of adverse reactions actively reported by pig farmers using Paylean did not reach 218,116 cases, and the latest figure had been updated to between 160,900 and 170,400 cases. However, Hsu Tien-lai mentioned that the United States currently raises 62 million pigs each year, and compared with the above reported figures, the ratio is still low, and the figure cannot show that ractopamine causes harm to pigs or the human body.

However, if ractopamine is compared with other animal drugs, why the number of reported adverse reactions in pigs far exceeds that of other drugs is a part that needs to be clarified at the third meeting of the technical advisory group of the "Food and Drug Safety Special Report" convened by the Executive Yuan this Saturday.

Reference materials provided by Helena Bottemiller

Helena Bottemiller : Ractopamine and Pigs: Looking at the Numbers

Helena Bottemiller : Dispute over drug in feed limiting US meat exports

Summary of the "Cumulative Veterinary Adverse Drug Experience" compiled by the U.S. Food and Drug Administration's Center for Veterinary Medicine (page 242 concerns the effects of ractopamine on pigs)

Detailed content of the "Cumulative Veterinary Adverse Drug Experience" recorded by the U.S. Food and Drug Administration's Center for Veterinary Medicine ((click N-S - ADE Summaries and see page 179; the download process takes about 1-2 minutes)

Internal U.S. Food and Drug Administration documents obtained by Helena Bottemiller under the U.S. Freedom of Information Act: 1. records of reported adverse reactions in pigs; 2. records of reported adverse reactions in all animals

Warning letter sent by the U.S. Food and Drug Administration to Elanco: Elanco Animal Health 12-Sep-02

The effects of ractopamine on the behavior and physiology of finishing pigs - Journal of Animal Science, 2003

Effects of a "step-up" ractopamine feeding program, sex, and social rank on growth performance, hoof lesions and Enterobacteriaceae shedding in finishing pigs - Journal of Animal Science, 2008

Behavior and peripheral amine concentrations in relation to ractopamine feeding, sex and social rank of finishing pigs - Journal of Animal Science, 2009

Aggressiveness and brain amine concentration in dominant and subordinate finishing pigs fed the β-adrenoreceptor agonist ractopamine - The Journal of Animal Science, 2010