Acceptable vs. Unacceptable Risk
Any drug must be evaluated in terms of
risk to the patient. When a disease is life threatening patients
may decide to take a drug that could cure them even though the
drug comes with published known negative side effects or even
risk of death. This is a choice for the patient and doctor to
decide. They must have full disclosed knowledge of the possible
consequences as well as the claimed benefits of using the drug.
Drug manufacturers have a legal and moral obligation to inform
physicians and patients of all the risks associated with drugs
after exhaustive testing and clinical trials. They also have
an obligation to re-evaluate the risks of damaging side effects
when reports come in after it has been on the market.
Lawsuits concerning the damaging effects of drugs is on he rise.
The enormous profits drug manufacturers hope to gain from the
sale of certain drugs may outweigh the need to continue with
clinical trials, provide adequate warning labels or re-evaluate
the drug after negative reports have come in. Drug companies
must be held accountable if they have failed in their duty to
provide adequate information and monitor their products.
Sibutramine (Meridia) was the first weight-loss drug to be given the OK since the 1997 bans on Redux, also known as dexfenfluramine, and fenfluramine, the "fen" in fen-phen, following reports that the drugs caused heart valve damage.
While the same effects on the heart valves that plagued fen-phen and Redux were not noted, sibutramine does have some potentially serious cardiovascular side effects that are noted on the drug's label.
Meridia has been associated with 29 deaths, including 19 from adverse cardiovascular effects and hundreds of adverse reaction reports worldwide.
The department of Health in Britain reports that two patients taking the anti-obesity drug Reductil (Meridia) in Britain have died and more than 200 others have had suspected adverse reactions.
Italy suspended sales last week after reports of health problems including two fatalities,
Earlier this week French drug regulators reported that they had received 99 reports of side effects, ten of them serious, but no fatalities in patients taking sibutramine.
Meridia is an orally administered controlled substance in Schedule IV of the Controlled Substances Act (CSA) which means some patients could become addicted.
The Following is taken from the information for patients published by Abbott Laboratories
Description
Meridia (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity.
Who should not take Meridia?
* Patients receiving monoamine oxidase
inhibitors (MAOIs)
* Patients who have anorexia nervosa
* Patients taking other centrally acting appetite suppressant
drugs
* Patients with hypersensitivity to sibutramine or any of the
inactive ingredients of sibutramine hydrochloride monohydrate
Special Warnings with Meridia:
* Sibutramine substantially increases blood
pressure in some patients. Regular monitoring of blood pressure
is required when prescribing sibutramine.
* Sibutramine is a norepinephrine, serotonin and dopamine reuptake
inhibitor and should not be used concomitantly with MAOIs
* Treatment with sibutramine has been associated with increases
in heart rate and/or blood pressure. Therefore, sibutramine should
not be used in patients with a history of coronary artery disease,
congestive heart failure, arrhythmias, or stroke.
Meridia may not be right for you, if you:
* Have glaucoma. Because sibutramine can
cause mydriasis, it should be used with caution in patients with
narrow angle glaucoma.
* Organic causes of obesity (e.g., untreated hypothyroidism)
should be excluded before prescribing sibutramine.
General Precautions with Meridia:
Pulmonary Hypertension
Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH), a rare but lethal disease. In premarketing clinical studies, no cases of PPH have been reported with sibutramine. Because of the low incidence of this disease in the underlying population, however, it is not known whether or not sibutramine may cause this disease.
Seizures
During premarketing testing, seizures were reported in <0.1% of sibutramine-treated patients. Sibutramine should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.
Gallstones
Weight loss can precipitate or exacerbate gallstone formation.
Renal/Hepatic Dysfunction
Patients with severe renal impairment or severe hepatic dysfunction have not been systematically studied; sibutramine should therefore not be used in such patients.
Interference With Cognitive and Motor Performance
Although sibutramine did not affect psychomotor or cognitive performance in healthy volunteers, any CNS active drug has the potential to impair judgment, thinking or motor skills.
Possible side effects of Meridia:
* headache
* backache
* flu-syndrome
* abdominal pain
* chest pain
* neck pain
* dry mouth
* anorexia
* insomnia
* constipation
If you or someone you know is taking Merida and have experienced Dangerous Side effects, you may be entitled to compensation.
Contact us for legal consultation
Primary Pulmonary Hypertension Treatments | Mesothelioma Cancer Center | Paxil Suicide Lawsuits | Stock Fraud Lawsuits | Erbs Palsy Claims
Boston Lawyer Referral | Car Accidents.com
Personal Injury Lawyers