Consumer Reports More Alarmed by Dangers of Weight
Loss Drugs Alli, Xenical Than FDA
CR warning based on several thousand
adverse events linked with orlistat, the active ingredient in Alli
and Xenical; FDA reviews reports of liver injury
Aug. 28, 2009 – The Food and Drug Administration
said Monday it is reviewing “adverse event reports of liver injury” in
patients taking the weight loss drug orlistat, marketed as the
prescription drug Xenical and the over-the-counter medication Alli, but
said those taking the drug should continue to use it as directed.
Consumer Reports, however, has jumped into the fray saying, “Skip this
drug.”
CR’s report, posted online at
http://www.ConsumerReportsHealth.org, is based on a review of
several thousand adverse event reports associated with orlistat, the
active ingredient in the OTC Alli and the prescription drug Xenical. The
reports were collected through a Freedom of Information Act request
filed with the FDA earlier this year, CR stated in a news release.
Those reports, notes CR, “show a pattern of adverse
events submitted to the agency since Jan. 1, 2007, including rectal
bleeding and kidney, liver and thyroid problems. Those reports don’t
prove that orlistat is to blame; but only that those conditions are
associated with the use of Alli and Xenical. To date, a clear link
between the use of the drug and a majority of those side effects has not
been firmly established."
“The bottom line: the risks of orlistat vastly
outweigh the benefits,” the CR release states. “The millions of
Americans who legitimately need to lose weight are far better off
avoiding orlistat and weight-loss gimmicks. They should focus instead on
what has been shown to work, without the risks: engaging in regular
exercise eating fewer calories, and sticking with both.”
CR’s report goes on to claim there have been “slim
benefits and embarrassing side effects associated with Alli and
Xenical.”
“In fact, even when orlistat is combined with
exercise and nutritional changes, it produces only a modest 5 percent to
10 percent decline in body weight.
“Now, the embarrassing part: In clinical trials of
Xenical, during the first year of use, 27 percent had gas with
involuntary discharge of stool, 22 percent experienced fecal urgency, 11
percent had an increased number of bowel movements, and 8 percent
suffered fecal incontinence.
“Virtually everyone who takes orlistat experiences
diarrhea, at least, occasionally.”
The FDA says it received 32 reports of serious
liver injury in patients taking orlistat between 1999 and 2008. Of those
cases, 27 reported hospitalization and six resulted in liver failure.
Thirty of the adverse events occurred outside the United States.
The most commonly reported adverse events included
yellowing of the skin or whites of the eyes (jaundice), weakness, and
stomach pain, according to the FDA.
The FDA reports it is reviewing additional data
submitted by orlistat manufacturers on suspected cases of liver injury,
and the issue has been discussed at the FDA’s Center for Drug Evaluation
and Research Drug Safety Oversight Board.
“The issues here are complex, but FDA has benefited
from the input of the Board, including comments from representatives
from three FDA Centers and several other Agencies in the Department of
Health and Human Services,” said Steven Osborne, M.D., executive
director of the Board.
The FDA’s analysis of these data is ongoing, and no
definite association between liver injury and orlistat has been
established at this time. Consumers taking Xenical should continue to
take it as prescribed, and those using over-the-counter Alli should
continue to use the product as directed.
Full text of the Early Communication about an
Ongoing Safety Review can be found
here. The Early Communication is a risk communication tool used by
the FDA to inform the public about its ongoing safety reviews of drugs.
The FDA will release its findings on orlistat as soon as the review is
completed.
Consumers who have used orlistat should consult a
health care professional if they experience symptoms possibly associated
with development of liver injury, particularly weakness or fatigue,
fever, jaundice, or brown urine. Other symptoms may include abdominal
pain, nausea, vomiting, light-colored stools, itching, or loss of
appetite.
Americans are getting fatter. The percentage of
obese people in the U.S. has doubled—from 15 percent to 32 percent—in
the last two decades. To stave off those unwanted pounds, consumers
spend billions of dollars a year on weight loss products. While it is
clear that weight loss in general can improve health, according to
Consumer Reports’ medical advisers, orlistat is not the answer.
The FDA urges both health care professionals and
consumers to report suspected side effects from the use of orlistat to
FDA's MedWatch Adverse Event Reporting program either online, or by
regular mail, fax, or phone.
●
Online
● Regular Mail: use postage-paid
FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD
20852-9787
● Fax: 800-FDA-0178
● Phone: 800-FDA-1088
