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April 8, 2003
New Meridia studies will be published in the Journal of the American
Medical Association’s April 9th issue. A study was performed
by researchers at the Weight and Eating Disorders Program of the
University of Pennsylvania School of Medicine as the first controlled
trial in overweight teenagers using Meridia.
The Meridia study investigated 82 adolescents between ages 13
and 17 with an average weight of 228 pounds. While the study concluded
Meridia was an aid in decreasing the level of hunger amongst the
study participants, leading to an average weight loss of 23 pounds,
Meridia has worrisome side effects associated to the weight loss
drug.
Meridia side effects in the study included both increased blood
pressure and an increased pulse rate. Since overweight people
already have increased risk for high blood pressure and stressors
resulting in increased pulse rate, as is, the addition of Meridia
could be a potentially serious situation. In March 2002, the Public
Citizen consumer group sent the FDA a petition for the immediate
ban of Meridia due to the 29 deaths linked to Meridia, including
19 of the deaths caused by cardiovascular events.
Currently, Meridia is available to just adults 16 and older.
The FDA advisers voted 5-4 against the approval of Meridia, however
the FDA still approved the drug despite the concerns of elevated
blood pressure and increased heart rate. Again in May 2002, Public
Citizen sent a letter urging Meridia be banned after the group
pointed to FDA evidence showing Meridia maker Abbott Laboratories
had failed to provide accurate information regarding Meridia,
making claims unsupported by source data or with missing additional
information found in the source data.
June 12, 2002
Chicago Tribune, "Abbott Slides On FDA, Profit News"
Shares of Abbott Laboratories plunged 16 percent after the medical
product giant said it would take a $140 million charge to cover
additional costs and penalties from a punishing consent decree
it signed with the Food and Drug Administration in 1999. The revelations
come less than a month after North Chicago-based Abbott disclosed
that its Lake County diagnostic test-making facilities unexpectedly
failed a key FDA inspection. The reduction of Abbott's earnings
guidance also reflected slower-than-expected sales of its controversial
diet drug Meridia and foreign currency pressures, particularly
from the devalued Argentine peso, the company said. Abbott is
waiting for a determination from the FDA and European officials
on the fate of its diet drug Meridia, which has come under regulatory
scrutiny because of reports of patients dying after taking it.
Abbott said sales originally projected at $400 million are now
expected to be $300 million, largely because of what the company
called "negative publicity" after Italian officials
suspended sales of the drug and the U.S. consumer group Public
Citizen called for a ban.
June 6, 2002
Associated Press, "Five Sue Diet Drug Maker Over Alleged
Side Effects"
Five users of the diet drug Meridia are suing Abbott Laboratories
over alleged side effects, including heart problems. The lawsuit
filed Wednesday in U.S. District Court in Cleveland, Ohio, asked
that Abbott Laboratories stop selling the Meridia diet drug, and
to pay for both the medical expenses and loss of earnings brought
on by the drug's alleged side effects.
March 15, 2002
BBC News - "Patients Die After Taking Obesity Drug"
Two patients have died and more than 200 others have reported
suspected adverse reactions after taking the anti-obesity drug
Reductil (Meridia) in the UK.
However, the Department of Health has said there is no reason
for people who are taking the drug to stop. The deaths are thought
to have been caused by the patients' underlying medical condition
rather than by anything to do with Reductil (technical name sibutramine).
Sales of the drug were suspended in Italy last week after reports
of health problems, including two fatalities. Italy's Pharmaceutical
Commission decided that the beneficial effects of the drug must
be re-evaluated. Other national agencies have been examining the
number of adverse drug reaction reports in preparation for a Europe-wide
review by the European Medicines Evaluation Agency. The Department
of Health said that 93 people had suffered a serious adverse reaction
after taking the drug.
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