Meridia and Other Rx Diet Drugs and their Risks

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

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.

FDA : Recent Recalls

Image via Wikipedia
The folks at the FDA have been busy the past several weeks. Here's a short list of recalls:

Amgen Initiates Voluntary Nationwide Recall of Certain Lots Of Epogen® And Procrit® (Epoetin Alfa):The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The products are indicated for the treatment of anemia related to HIV therapy, chronic renal failure, and chemotherapy. Link.

 

Pfizer Consumer Healthcare Issues Voluntary Recall of One Lot of ThermaCare HeatWraps Menstrual Product  The company said it is taking this precautionary step after finding a potential for a leak of the components contained in the wrap, which could cause skin injury such as irritation or burn. Link

 

Recall of AROM-X Capsules, AROM-X UTT Liquid, AROM-XL Liquid, 4-AD Capsules and Decavol Capsules Marketed as a Dietary Supplements Containing ATD: FDA's states that the ingresidnets 1,4,6 etioallocholan-dione do not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.

 

Recall of Reversitol a Product Marketed as a Dietary Supplement Containing ATD: FDA has requested that iForce Nutrition inform consumers that adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction. Consumers with liver, kidney, adrenal, or prostate abnormalities are at higher risk for developing adverse events. iForce Nutrition has not received any adverse event reports nor are they aware of any adverse events associated with the use of these products. Link.

 

 

 

 

Meridia: Heart Attack Warning Added to Label; Banning urged n Europe

The FDA is warning doctors that weight loss pill Meridia may increase the risk of heart attack and stroke in patients with a history of heart problems.

The FDAis adding new labeling to the drug, stressing that it should not be used in patients with heart failure, hypertension, irregular heart beats and other problems.

Meridia was introduced into the market in 1997 as a weight loss pill. It's Sibutramine, and can be found as sibutramine hydrochloride monohydrate.

The European Medicines Agency advised doctors to stop prescribing medicines containing sibutramine, which are sold under the names Reductil, Reduxade and Zelium in Europe and Meridia in the United States.

"The risks of these medicines are greater than their benefits," EMEA said in a statement.

The European Commission will consider the recommendation for suspension of marketing approval.

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