Meridia SCOUT Study
According to Abbott, he FDA’s request for the company to remove Meridia from the US market is based mainly on the results of the SCOUT (Sibutramine Cardiovascular OUTcome Trial) study. The study researched approximately 10,000 patients over 6 years, and was requested by European regulatory authorities as a post-marketing commitment to evaluate cardiovascular safety in high-risk patients.
SCOUT showed that the average difference in body weight between people on Meridia and those on a placebo was about 2.5%, yet there was a 16% increase in the risk of heart attacks and strokes. This apparent risk-to-benefit ratio was not acceptable to the FDA, prompting a request to Abbot that they should recall Merida.
Do I have a Meridia Recall Side Effects Injury Lawsuit?
The Defective Drug & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Meridia side effects injury lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
What side effects can this medication cause?
Sibutramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
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headache
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change in appetite
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constipation
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heartburn
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dry mouth
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weakness
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back pain
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nervousness
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difficulty falling asleep or staying asleep
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runny nose
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flu-like symptoms
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flushing
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painful menstrual periods
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
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fast or pounding heartbeat
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chest pain
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shortness of breath
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nausea
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stomach pain
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vomiting
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extreme excitement
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restlessness
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anxiety
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depression
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dizziness
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lightheadedness
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fainting
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confusion
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uncoordinated or abnormal movement
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muscle stiffness
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shaking hands that you cannot control
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seizures
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shivering
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excessive sweating
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fever
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sore throat
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large pupils (black area in center of eyes)
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change in vision
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eye pain
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hives
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skin rash
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itching
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difficulty speaking, breathing, or swallowing
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hoarseness
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swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
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unusual bleeding or bruising
Sibutramine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
