Italy's health minister Girolamo Sirchia has suspended sales of anti-obesity drugs containing sibutramine after 50 reports of adverse events among people taking the medicines.
The decision follows a report from the General Directorate for the Evaluation of Drugs and Pharmacovigilance. All drugs that contain sibutramine, including Abbott's anti-obesity drug Reductil (called Meridia in the US), have been withdrawn from the market.
"Based on 50 reports of adverse events during treatment, the CUF (Drugs Committee) decided that the beneficial effects of the drug must be re-evaluated."
Sibutramine-based drugs have been on the Italian market since April 2001.
The ministry advises people currently using sibutramine to stop taking the medicines and seek advice from their doctor.
Dr. Eugene Sun, the vice president for pharmaceutical development at Abbott reported that the company has received reports of 32 deaths in people who were taking sibutramine, with 28 in the US, two in Italy, one in Switzerland, and one in South Africa.
About 20,000 Meridia prescriptions are filled in the US each week, according to the FDA. Abbott said that 8.5 million people worldwide have taken the drug.
The drug was approved for use in the US in 1997. A risk of increased blood pressure and heart rate have been reported in some patients taking it.
Reuters Florence March 7, 2002
In July 1997, I warned that researchers at the Mayo Clinic discovered a possible association between valvular heart disease and use of prescription diet pills containing fenfluramine and phentermine, dubbed "fen-phen". Redux was withdrawn from the market in September of 1997.
However, in November of 1997 Meridia was approved in the US for weight loss. Meridia is a neurotransmitter reuptake inhibitor that works by affecting natural chemicals in the brain involved in regulating appetite. The appetite control center in the brain is believed to regulate the amount of food eaten through feelings of hunger and fullness.
Meridia is associated with many side effects.
More common side effects may include: Abdominal pain, acid indigestion, anxiety, back pain, constipation, cough increase, depression, dizziness, dry mouth, flu symptoms, headache, increased appetite, insomnia, joint pain, loss of appetite, loss of strength, nasal inflammation, nausea, nervousness, painful menstruation, rash, sinus inflammation, stomachache, sore throat.
Less common side effects may include: Acne, abnormal thinking, agitation, allergic reaction, arthritis, bronchitis, changes in taste, chest pain, dental problems, diarrhea, difficulty breathing, drowsiness, ear pain, ear problems, emotional changes, fever, gas, heavy uterine bleeding, herpes simplex virus, increased heart rate, increased blood pressure, itching, laryngitis, leg cramps, menstrual problems, migraine headache, muscle ache, neck pain, rectal problems, reduced vision, stimulation, stomach and intestinal inflammation, sweating, swelling, thirst, throbbing heartbeat, tingling skin sensation, urinary tract infection, vaginal yeast infection, vomiting.
Rare side effects may include: Bleeding problems, kidney problems, seizures.
Although Meridia is still available in the US, I would caution anyone using it to discontinue its use immediately. My prediction is that the US will likely follow Italy's lead and remove the drug from market in the future.
Don't wait like those who were damaged with heart disease by Redux, the other obesity drug that was pulled from the market in 1997.
Losing weight is a major challenge.
The major approach, of course, would be to follow the eating plan.
I have been using EFT quite successfully in my practice to help people address the nearly universally emotional stresses that contribute to the problem. You can review the EFT Resource page for how you can use this for your own weight loss program.
Related Articles:
The Scientific Definition of Obesity and its Dangers