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In light of the U.S Food and Drug Administration (FDA) review of orlistat (alli) in relation to liver injury please find below a statement from GlaxoSmithKline Consumer Healthcare (GSK).
GSK is updating the alli (orlistat 60 mg) product label in the United States to inform people using alli that if they experience certain symptoms that have been associated with rare instances of severe liver injury to stop using the product and speak with their doctor.
The European approved product label for alli already carries similar information.
This precautionary action follows the FDA’s review of reports of liver injury in a limited number of people using orlistat, the active ingredient in alli, that were collected over a span of more than 10 years. The update is being implemented in conjunction with Roche, the manufacturer of the prescription dose of orlistat.
The FDA announcement states that: At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established.
Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of the prescription dose of orlistat and alli, to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur.
Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury. Severe liver injury can occur in people not taking drugs and without a distinct cause.
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