Sibutramine: Appetite Suppressant
In November 1997, the Food and Drug and Drug Administration approved the sale and distribution of Sibutramine. Prescribed for patients initial body mass index (BMI – Statistical measure of the weight of a person scaled according to height. BMI of less than 20: Underweight. Over 25 BM: Overweight, and over 30: Obese) at least 30 or 5′ 06″ and weights 185 pounds or more (Or Weight – loss aid for people 16 years or older). During clinical trials, sibutramine had shown weight loss during the first six months of treatment and weight loss was maintained for one year. However, contrary to FDA approval of this drug, the advisory committee to the FDA voted against its approval by a five to four vote. There concern was based upon the health risks associated with the use of Sibutramine (Meridia) for the treatment of obesity, despite future benefits. Between, February 1998 until September 2001, reported to the FDA 397 adverse reactions, including 152 hospitalizations, and 29 deaths.
Information should be considered before taking Sibutramine: The medication is not recommended for those with uncontrolled high blood pressure. Sibutramine may be taken with or without food, unless others instructed by the patient’s physician. The prescribed dosage will be different for each patient. A missed dose can be taken within two or three hours, however if the missed dosage is missed, return to regular dosing schedule (Double doses is not advisable). Recommended not to drink excess alcohol while taking sibutramine, because it may worsen certain side effects of the medication. Use caution when driving, operating machinery or performing other hazardous actives, which may cause dizziness or restlessness, after taking the medication. When storing the medication, keep away from heat and direct light. Sibutramine has never been tested on pregnant women (Listed in FDA pregnancy category ‘C.’ Means that it is not known whether this medication will harm an unborn baby), but studies in animals have shown birth defects (Doses where higher than prescribed for human use). Also, risk of infants breast – feeding while taking the medication. Women should inform their physicians prior to taking the medication, if planning on getting pregnant or already pregnant. The possibility of developing physical or psychological dependence is low. Currently, no long term study results of sibutramine, more than one year.
Sibutramine has been known to have a variety of side effects from common to rare. Common side effects include: acid indigestion, abdominal pain or stomachache, back pain, constipation, cough increase, depression, dizziness, flu symptoms, headache, insomnia, joint pain, loss of strength, nasal inflammation, nervousness, painful menstruation, rash, sinus inflammation, and sore throat. Also, dryness of the mouth, which can be relieved by sugarless candy or gum, melted bits of ice placed in the mouth or use of saliva substitute. Rare side effects include: Excessive bleeding following an injury, kidney problems and seizures. Patients that are taking other types of medications need to notify their physician, prior to taking sibutramine, which may cause side effects or interfere with their prescribed medications. Presence of medical problems may affect the use of sibutramine. These medical problems include: Anorexia, narrow-angle glaucoma or thyroid problems, high blood pressure, brain disease or damage, history of heart disease, kidney disease, liver disease, and history of seizures.
The recommended starting dosage for Merida is 10 milligrams once daily. If at least four pounds, is not lost within four weeks of starting the medication, then the dosage would increase to 15 milligrams daily. The maximum amount recommended. If the increase dosage does not reduce weight, then the medication would be discontinued.
In the United States, 16 percent of the American teenagers are overweight or obese, according to the Centers of Disease Control (2006). According to a study, published in the Annals of Internal Medicine, teenage girls who are obese, have a three times greater risk of premature death upon reaching middle age. In July 2006, published article in the Annals of Internal Medicine, a study confirmed the use of sibutramine, along with behavioral counseling for treating obesity in children. First time the medication was tested for those under, sixteen years old. The study conducted by Dr. Robert Berkowitz of the Children Hospital of Philadelphia (The nation’s first pediatric hospital), and funded by Abbott Laboratories, manufacturer of the drug. The clinical test involved 498 obese adolescents, ranging from age groups 12 to 16 and average initial weight of 215 pounds. These adolescents where divided into two groups. One of the groups where given a sugar pill placebo and the other given sibutramine. Conclusion of the clinical test, had shown those taking the medication had an average weight loss of 14 pounds in one year. Those taking the drug had shown side effects ranging from moderate increase in blood pressure and pulse rate, which required monitoring. The Food and Drug Administration has not yet approved sibutramine, for those younger than sixteen years of age, until further long – term studies have been concluded.
