Common Sense Needed, not new risky weight loss drug
Tuesday, July 13, 2010
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Obesity Concerns Not Cured by A Risky Drug: FDA Plans to Review First of 3 New Diet Drugs
Remember Phen-Fen, an older alleged weight loss drug that harmed the hearts of many and often caused pulmonary hypertension among its other gifts?
It may be reappearing in a different form, a new concoction of phentermine and topiramate, ready to be reviewed by our trusting folks at the FDA.
Phen-Fen: The once-popular diet-drug combination of fenfluramine and phentermine that, amidst much media attention, was taken off the market because of concern for heart valve damage.
Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethyl sulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solu tion has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: used for Seizure and Migraine
14 July, 2010 NEW YORK (AP) – Vivus Inc.'s potential weight loss drug Qnexa will likely draw scrutiny over nervous system and psychiatric side effects from a panel of Food and Drug Administration experts this week.
But shares jumped in morning trading as the FDA acknowledged the potential blockbuster drug's effectiveness in cutting weight. The stock rose $1.75, or 16 percent, to $12.40 in morning trading, more than doubling from a low of $5.57 last July.
The FDA raised some concerns in briefing documents posted online on Tuesday about a range of side effects. It said reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others. The concerns were not a surprise to Wall Street, which has been following development of the drug over the last several years. Complete article
Remember Phen-Fen, an older alleged weight loss drug that harmed the hearts of many and often caused pulmonary hypertension among its other gifts?
It may be reappearing in a different form, a new concoction of phentermine and topiramate, ready to be reviewed by our trusting folks at the FDA.
Phen-Fen: The once-popular diet-drug combination of fenfluramine and phentermine that, amidst much media attention, was taken off the market because of concern for heart valve damage.
Fenfluramine hydrochloride is an anorectic drug for oral administration. Immediate release tablets containing 20 mg fenfluramine hydrochloride are orange, scored, compressed tablets engraved AHR and 6447.
Inactive Ingredients: Corn Starch, FD&C Yellow 6, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sodium Lauryl Sulfate.
Fenfluramine HCl - one of many fluoride based drugs - has the following chemical name: N-ethyl-alpha-methyl-3-(trifluoromethyl) benzeneethanamine hydrochloride.The most common adverse reactions of fenfluramine are drowsiness, diarrhea, and dry mouth. Less frequent adverse reactions reported in association with fenfluramine are:
- Central nervous system: Dizziness; confusion; incoordination; headache; elevated mood; depression; anxiety, nervousness, or tension; insomnia; weakness or fatigue; increased or decreased libido; agitation, dysarthria. Gastrointestinal: Constipation; abdominal pain; nausea. Autonomic: Sweating; chills; blurred vision. Genitourinary: Dysuria; urinary frequency. Cardiovascular: Palpitation; hypotension; hypertension; fainting; pulmonary hypertension. Skin: Rash; urticaria; burning sensation. Miscellaneous: Eye irritation; myalgia; fever; chest pain; bad taste.
Drug Abuse and Dependence
Fenfluramine hydrochloride is a controlled substance in Schedule IV. Fenfluramine is related chemically to the amphetamines, although it differs somewhat pharmacologically.Topiramate is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethyl sulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solu tion has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: used for Seizure and Migraine
14 July, 2010 NEW YORK (AP) – Vivus Inc.'s potential weight loss drug Qnexa will likely draw scrutiny over nervous system and psychiatric side effects from a panel of Food and Drug Administration experts this week.
But shares jumped in morning trading as the FDA acknowledged the potential blockbuster drug's effectiveness in cutting weight. The stock rose $1.75, or 16 percent, to $12.40 in morning trading, more than doubling from a low of $5.57 last July.
The FDA raised some concerns in briefing documents posted online on Tuesday about a range of side effects. It said reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others. The concerns were not a surprise to Wall Street, which has been following development of the drug over the last several years. Complete article
Side effects include but may not be limited toCardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Allergic: Urticaria.
Endocrine: Impotence, changes in libido.
Sensible responses to weight issues are welcome.
Our main organization, CHI, offers nutritional and spiritual counseling
If the 'Phen' proportion isn't bad enough consider the anti-seizure drug's problems. Just check out page three of this drug information database and evaluate for yourself.
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