Showing posts with label meridia recall georgia. Show all posts
Showing posts with label meridia recall georgia. Show all posts

Tuesday, October 19, 2010

Meridia and Other Rx Diet Drugs and their Risks

Medication used for obesity. Orlistat and sibu...Image via WikipediaThe real risks of heart attacks, strokes and other possible long-term side effects still are not completely known, even after Meridia was studied and pulled from the market.

Other prescription diet pills include orlistat (Xenical by prescription, Alli over-the-counter), phentermine (Adipex-P), diethylpropion (Tenuate), and phendimetrazine (Bontril). They can help with short-term weight loss. Orlistat can potentially be taken for a longer period of time. None can be considered entirely safe, some folks say.

Orlistat is probably the safest of the five. It blocks the intestine from absorbing fat. The main side effects are frequent bowel movements, greasy stool and gas. You need to stay on a low fat diet to avoid these side effects. A long-term concern about orlistat is that some claim that a user may not get enough vitamins A, D, E, K and beta carotene. These vitamins need fat in the intestine to be absorbed.

Phentermine, diethylpropion and phendimetrazine decrease appetite for the first few weeks of use. They may be prescribed to jump-start weight loss as part of a lifestyle modification program.

http://www.latimes.com/health/sns-health-ask-harvard-meridia-diet-pills,0,6548317.story


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Tuesday, October 12, 2010

10/12/10 Georgia Meridia Recall Lawyer -Background on the product

Meridia is also known as Sibutramine. Until recently it was marketed and prescribed as an adjunct in the treatment of exogenous obesity along with diet and exercise.
My office is investigating claims of injury because of this recalled product.


Sibutramine is a centrally-acting serotonin-norepinephrine reuptake inhibitor. Serotonin and norepinephrine reuptake inhibitors (SNRIs) are a type of antidepressant medication that increases the levels of both serotonin and norepinephrine by inhibiting their reabsorption (reuptake) into cells in the brain. Although the precise mechanism of action isn't clear, it's thought that these higher levels enhance neurotransmission — the sending of nerve impulses — and so improve and elevate mood. Medications in this group of antidepressants are sometimes called dual reuptake inhibitors.


 
Sibutramine was originally launched and marketed by Knoll Pharmaceuticals and was most recently manufactured and marketed by Abbott Laboratories before its withdrawal from the market.
This product should not be used by people with with:
  • Psychiatric conditions 
  • Patients with a history of or a predisposition to drug or alcohol abuse
  • Patients below 18 and above 65 years of age
  • History of peripheral arterial disease
  • Hypertension that is not sufficiently controlled (e.g., > 145/90 mmHg), caution in controlled hypertension
  • Existing pulmonary hypertension
  • Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
  • A history of coronary artery disease (e.g., angina, history of myocardial infarction), congestive heart failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or cerebrovascular disease (stroke or transient ischemic attack (TIA)
  • Stroke or transient ischemic attack (TIA)
  • Hyperthyroidism (overactive thyroid gland)
What are the common side effects?
Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.
Sibutramine may  substantially increase blood pressure and pulse in some patients.
These side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).
Symptoms that require urgent medical attention are seizures, problems urinating, abnormal bruising or bleeding, melena, hematemesis, jaundice, fever and rigors, chest pain, hemiplegia, abnormal vision, dyspnea and edema.
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Monday, October 11, 2010

Meridia Withdrawal News

From the FDA:

AUDIENCE: Primary Care, Consumers

ISSUE: Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary withdrawal of Meridia (sibutramine), an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.

BACKGROUND: Meridia was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

RECOMMENDATION: Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.

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