The FDA issued a warning about Alli in 2011, citing concerns about liver injury. This prompted GlaxoSmithKline, the manufacturer, to revise the product label, adding stronger cautions about potential side effects.
Specifically, the updated label emphasized the risk of liver damage and highlighted the importance of consulting a doctor before starting Alli. The company also increased the prominence of warnings about gastrointestinal side effects, such as oily spotting, loose stools, and urgent bowel movements.
Further changes included refining the recommended dosage and providing clearer instructions on proper use. GlaxoSmithKline also implemented stricter quality control measures during the manufacturing process.
These modifications aimed to reduce the incidence of adverse events associated with Alli use. The FDA continues to monitor the safety and efficacy of Alli, and consumers are encouraged to report any adverse reactions they experience.
