72 Weight-Loss Products Illegally Spiked With Prescription Drugs

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72 Weight-Loss Products Illegally Spiked With Prescription Drugs

FDA Response “Inadequate,” Public Citizen Says

WASHINGTON - At least 72 weight-loss products have been found by the
Food and Drug Administration (FDA) to contain prescription drugs,
including four drugs not approved by the FDA for sale in the U.S.,
Public Citizen writes in a Worst Pills, Best Pills News article released today on WorstPills.org, the organization’s drug safety Web site.

This is the third time in the past six months that the FDA has
announced alerts about the illegal addition of active prescription drug
ingredients to otherwise ineffective weight-loss supplements. Because
the added drugs are active in the body, they can be dangerous as well.
For instance, sibutramine (brand name Meridia, an appetite suppressant
available by prescription only and a controlled substance) and
fluoxetine (brand names Prozac and Serafem, an antidepressant available
by prescription only) were among the drugs found in the supplements.

The FDA has inspected a number of companies associated with the sale
of these illegal products and is currently seeking voluntary recalls of
the 72 products. Based on the FDA’s inspections and the companies’
responses to recall requests, the FDA may take additional enforcement
steps, such as issuing warning letters or initiat­ing seizures,
injunctions or criminal charges.

“The FDA’s response has been inadequate,” said Sidney M. Wolfe,
M.D., director of Public Citizen’s Health Research Group and acting
Public Citizen president. “Some of the drugs found in these supplements
are dangerous and are putting people at an unacceptable risk of injury.
To protect citizens, the agency needs to go further and seize these
products.”

The affected weight-loss products are categorized as dietary
supplements by the FDA. Due to the 1994 Dietary Supple­ment Health and
Education Act (DSHEA), which clarified that dietary supplements were to
be regulated essentially as foods rather than as drugs, dietary
supplements are not subject to the better-controlled process for
approval and manufacturing as drugs.

Thus, the manufacturers of dietary supplements are not required to
submit proof that their products are safe and effective, or that the
amount of a substance claimed to be in a supplement is ac­tually in the
supplement, or that contaminants or active drugs are not present.
Moreover, on the rare occasions on which dietary supplements have been
subjected to the same rigorous, controlled trials as drugs, the
majority of supplements have been found to be ineffective.

Dietary supplement manufacturers sometimes seek to gain a
com­petitive advantage by clandestinely adding prescription drugs to a
largely inactive dietary supplement. Unfortunately for the companies,
this has the side effect of converting these products from dietary
supple­ments into prescription drugs. To sell prescription drugs
without FDA approval is illegal, providing the basis for the FDA’s
possible actions.

“Most dietary supplements do not fall under the jurisdiction of the
FDA, but this is one case where all of these products are clearly in
violation of the laws that govern drugs,” Wolfe said. “The FDA has not
exercised its legal authority to seize all of these products and take
them off the market, and anything short of that simply is not good
enough.”

WorstPills.org includes the full list of 72 implicated weight-loss
products, as well as the nine drugs they may contain. These include, in
addition to Meridia and Prozac/Serafem, fenproporex (a stimulant drug
not approved for marketing in the U.S.); bumetanide (brand name Bumex,
a potent diuretic available by prescription only); furosemide (brand
name Lasix, a potent diuretic available by prescription only);
rimonabant (brand name Zimulti, an appetite suppressant not approved
for marketing in the U.S.); cetilistat (an experimental obesity drug
not approved for marketing in the U.S.); phenytoin (brand name
Dilantin, an anti-seizure medication available by prescription only);
and phenolphthalein (a solution used in chemical experiments and a
suspected cancer-causing agent that is not approved for marketing in
the United States). 

Some of the affected weight-loss products include Slimtech, 2 Day
Diet and Miaozi Slim Capsules. A full list of these products is
available on WorstPills.org.

Worst Pills, Best Pills News is a monthly newsletter available in
print and electronic formats through Public Citizen’s subscription Web
site, www.WorstPills.org.
The article about weight-loss products illegally spiked with
prescription drugs will be available free for the next seven days. The
site has other searchable information about the uses, risks and side
effects associated with prescription medications.

WorstPills.org is an unbiased analysis of information compiled from
well-regarded medical journals and unpublished data obtained from the
FDA, that allows Public Citizen to sound the alarm about potentially
dangerous drugs long before they are banned by the federal government,
and to recommend safer drugs. For example, Public Citizen warned
consumers about the dangers of Vioxx, ephedra, Baycol and Propulsid
years before they were pulled from the market.

 

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Public Citizen is a national, nonprofit consumer advocacy organization founded in 1971 to represent consumer interests in Congress, the executive branch and the courts.

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