Orlistat: No definite association with liver injury
Patients should continue
taking weight-loss drug as directed, and pharmacists should not alter
their orlistat counseling practices.
In a September 2 Dear
Pharmacist letter, GlaxoSmithKline reassured pharmacists and
patients regarding the safety and efficacy of its weight-loss product
alli (orlistat). The letter followed up on an FDA news release from
August 24 regarding the Agency’s ongoing review of liver-related
adverse events in patients taking orlistat. FDA stated that patients
taking prescription or OTC orlistat should continue to use the drug as
directed and that health professionals should not alter their orlistat
prescribing (or recommending) practices.
According to the FDA news release,
“no definite association between liver injury and orlistat has
been established at this time.” Between 1999 and October 2008, 32
reports of serious liver injury were submitted to FDA’s adverse
event reporting system. Jaundice, weakness, and abdominal pain were the
most commonly reported adverse events. Hospitalization was reported in
27 of the 32 cases, 30 of which occurred outside the United States. The
FDA CDER Drug Safety Oversight Board discussed the potential link
between orlistat and liver injury at an April 2009 meeting, and FDA is
reviewing other data on suspected cases of liver injury submitted by the
manufacturers of orlistat.
Patients should consult their
health professional if they are experiencing potential symptoms
associated with orlistat use and should report adverse effects from
using orlistat to the FDA
MedWatch program.
Orlistat is also marketed as
Xenical (Roche). More than 40 million patients have used orlistat since
it became available as a prescription medication in 1998. The safety of
the drug has been established through more than 100 clinical studies
involving more than 30,000 patients. Of note, evidence indicates that
approximately 15% to 20% of obese individuals have liver injury
resulting from excessive fat in the liver. Additionally, gradual weight
loss can improve liver function or prevent liver injury in obese
individuals. Because orlistat is minimally absorbed in the blood and
works locally in the gastrointestinal tract, the biological mechanism by
which the drug can potentially cause liver injury is unknown.
Web
links
Related resources on
pharmacist.com
Joe Sheffer (jsheffer@aphanet.org)
Posted September 4, 2009
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