The following chart is included in a FDA Freedom of Information report issued for Novartis Animal Health US, Inc.'s "Program 6 Month Injectable" flea control for cats.  As you can see, cats in the study group receiving the "Program Injectable" flea control product were eight times more likely to develop a post injection lump or granuloma than those cats in the placebo group.

Adverse Reactions: The following table compares the percentages of cats treated with lufenuron injectable compared to the placebo (saline) control that exhibited the following clinical observations.

 

Lufenuron Injection

N = 294

Placebo Injection

N = 102

Injection Site    

Pain on injection, tenderness, twitching or fractious during injection

16%

4.0%

Lump or granuloma

8.5%

1.0%
Vomiting

2.5%

0.6%
Listlessness/Lethargy

1.9%

0.6%
Diarrhea

1.3%

1.1%
Anorexia

1.1%

0.4%

Two injection site lumps removed from cats treated with lufenuron showed changes on histologic examination. In one cat the lump showed evidence of inflammation surrounding an area of necrosis. There was marked proliferation of fibrous connective tissue accompanying this reaction. In the other cat, the lump showed granulomatous inflammation which included non-pleomorphic fibrocytes and fibroplasia.

Below is a link to the complete FDA report from which the information above was obtained.  This comprehensive report details the summary of research that Novartis Animal Health US, Inc. presented to the FDA for approval of its "Program Injectable" flea control product.


"Link to the complete report"


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