U.S. District Court Dismisses Claims Against Abbott Laboratories' Anti-Obesity Medication Meridia(R) (Sibutramine HCL Monohydrat
14 Juillet 2004 - 11:14PM
PR Newswire (US)
U.S. District Court Dismisses Claims Against Abbott Laboratories'
Anti-Obesity Medication Meridia(R) (Sibutramine HCL Monohydrate)
C-IV -- Court Finds No Scientific Evidence to Support Plaintiffs'
Claim -- ABBOTT PARK, Ill., July 14 /PRNewswire-FirstCall/ -- The
U.S. District Court for the Northern District of Ohio last week
dismissed 113 cases against the company's anti-obesity medication,
Meridia(R) (sibutramine HCl monohydrate) C-IV. The court found that
the plaintiffs failed to come forward with sufficient scientific
evidence to support the claims. "The court's decision supports what
Abbott has long known, that Meridia, when combined with diet and
exercise, has been approved as a safe and effective option for the
treatment of obesity," said William G. Dempsey, senior vice
president of Pharmaceutical Operations and president of
Pharmaceutical Products Division. "We hope that this court decision
brings to a stop the alarming and medically inaccurate campaign of
fear, confusion and misinformation perpetuated by the plaintiffs'
attorneys and certain consumer watchdog groups." Meridia scientific
data is sound In its decision, the court held that the plaintiffs
lacked sufficient and reliable evidence to support their claims,
and concluded that an expert for the plaintiffs lacked appropriate
qualifications to address cardiovascular events. Likewise, the
court dismissed as "irrelevant" certain data produced by another
expert for the plaintiffs. Also, though not mandatory in cases of
this nature, the court noted that plaintiffs lacked epidemiological
evidence to support the claims. Meridia has been approved as a safe
and effective treatment for obesity when combined with diet and
exercise, and has been extensively studied in more than 100
clinical trials involving more than 12,000 patients throughout the
world. Approximately 13 million patients in more than 70 countries
have used sibutramine for the treatment of obesity. Meridia has
been approved in the U.S. since 1997. Meridia is an important
option for appropriate patients with obesity who, without
assistance of pharmacotherapy, are unable to manage their obesity
through diet and exercise alone. In studies, sibutramine, in
combination with diet and exercise, was effective in producing and
maintaining statistically significant weight loss in the majority
of obese patients compared to diet and exercise alone. In a
two-year trial, nearly three times as many patients on Meridia in
combination with diet and exercise maintained at least 80 percent
of their initial six-month weight loss when compared to patients
practicing diet and exercise alone. Research has shown that
maintaining a weight loss of five to ten percent of body weight
significantly reduces the risk of obesity-related adverse health
conditions. "Obesity is a serious disease that threatens the health
and well-being of a rapidly growing percentage of the population in
countries around the world," said Donna H. Ryan, M.D., professor of
medicine and associate executive director of clinical research at
Louisiana State University's Pennington Biomedical Research Center.
"Meridia is one of the few effective medical treatments we have
when diet and exercise alone are not enough. It may not work for
everyone, but it has helped, and continues to help, numerous
individuals lose weight." About Obesity Obesity is a serious
disease and a major risk factor for the development of
life-threatening illnesses such as coronary heart disease,
hypertension, stroke, type 2 diabetes and certain types of cancer.
In the United States, obesity can be attributed to 300,000 lost
lives per year and has substantial economic consequences for the
nation's health care system. In 2000, the total cost of health care
for obesity was estimated at $117 billion. Meridia(R) (sibutramine
HCI monohydrate) C-IV Use and Safety Information Meridia is
available only by prescription. It is indicated for weight loss and
maintenance of weight loss, and should be used in conjunction with
a reduced-calorie diet. Meridia is recommended for obese patients
with an initial body mass index (BMI) > 30 kg/m2 or > 27
kg/m2 in the presence of other risk factors (e.g., hypertension,
diabetes, dyslipidemia). Patients cannot take Meridia if they are
taking prescription medicines called monoamine oxidase inhibitors
(MAOIs). Meridia also cannot be taken if patients have anorexia
nervosa or bulimia nervosa, are taking other weight loss
medications that act on the brain or are allergic to any of the
ingredients of Meridia. Meridia's label states that the drug
substantially increases blood pressure in some patients. Patients
being treated with Meridia should see their doctor as directed for
regular monitoring of blood pressure and pulse rate. Meridia should
be given with caution to those patients with history of
hypertension and should not be given to patients with uncontrolled
or poorly controlled hypertension. Meridia should not be used in
patients with a history of coronary artery disease, irregular
heartbeats, congestive heart failure or stroke. Meridia should not
be used in patients with severe liver or kidney disease. It should
be used with caution in patients with narrow-angle glaucoma or a
history of seizures. It is important that patients discuss with
their doctor all current and past medical problems, all current
symptoms, all medications that they take or have taken
(prescription and over-the-counter medicines, including cough and
cold medications, and herbal products) and any prior allergies to
medicines. Patients should notify their doctor if they are taking
medications that regulate the neurotransmitter serotonin in the
brain: for example: Prozac(R) (fluoxetine), Zoloft(R) (sertraline),
Effexor(R) (venlafaxine), Luvox(R) (fluvoxamine), Paxil(R)
(paroxetine) or Zyban(R) (bupropion). Women who are pregnant or
planning to become pregnant or who are breast-feeding their infant
should not use Meridia. Patients need to talk to their doctors if
they are taking medications that may increase their risk of
bleeding (e.g. aspirin, clopidogrel, ticlopidine or Warfarin).
Meridia is classified as a Schedule IV drug in the U.S., and its
full prescribing information discloses it as such; patients who
abuse Meridia may become dependent. The most common side effects
include headache, dry mouth, anorexia, constipation and insomnia.
The brands listed are trademarks of their respective owners. For
more information about Meridia (sibutramine HCl monohydrate) C-IV,
including full prescribing information, please visit
http://www.meridia.net/ . Abbott Laboratories is a global,
broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.
The company employs more than 55,000 people and markets its
products in more than 130 countries. Abbott's news releases and
other information are available on the company's Web site at
http://www.abbott.com/ . DATASOURCE: Abbott Laboratories CONTACT:
U.S. Media, Laureen Cassidy, +1-847-938-7743, or Media Outside the
U.S., Sarah Henderson, +1-847-938-1170, or Financial Community,
John Thomas, +1-847-938-2655, all of Abbott Laboratories Web site:
http://www.abbott.com/ http://www.meridia.net/ Company News
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