Dr. Mercola April 06 2002 926 views
Claiming that the US Food and Drug Administration (FDA) should never have approved it, Public Citizen's Health Research Group petitioned the agency March 19 to take the weight-loss drug Meridia off the US market.
An FDA spokeswoman said the agency will review the petition and respond accordingly, adding that "FDA is concerned about the adverse events with Meridia," and is looking into the reports.
Sidney Wolfe, director of Health Research Group at Public Citizen stated that Meridia poses significant risks, without much benefit, claiming that the average weight loss with the drug is 6 to 11 pounds -- an insignificant amount for someone who is obese.
Everything was against approving this drug. He noted that an FDA advisory panel had voted against approval of the Abbott Laboratories drug in 1996, citing Meridia's tendency to elevate blood pressure.
An FDA reviewer also recommended against approval, and during trials, obese patients taking Meridia had a higher incidence of elevated heart rate and blood pressure, and abnormal electrocardiograms compared with those taking a placebo.
Since Meridia's introduction in early 1998 through September 2001, 152 patients taking the drug have been hospitalized and 29 have died, including three women under age 30, he said. The FDA also received reports of 143 patients who had a serious arrhythmia, or abnormal heart beat.
Responding to growing adverse reaction reports overseas and a decision by Italian authorities to temporarily suspend sibutramine sales on March 8, the FDA said on March 15 that it was monitoring the situation. The agency said it had reports of 25 deaths, 16 due to cardiac events.
Abbott said it has reports of 34 patients who have died worldwide while taking the drug. But the company said it appears that most of those deaths were not related to Meridia, which is sold as Reductil in Europe. The company notes that the drug has been used by 8.5 million people in more than 70 countries.
Abbott spokeswoman Melissa Brotz said the company "was not surprised" by Public Citizen's move to ban Meridia, but "we don't necessarily see what they're doing with any credibility," she added.
Reuters Washington March 19, 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 Redux was withdrawn from the market in September of 1997.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.
It sure seems like a matter of time before this drug is removed from the market.
If you, or someone you know is taking this drug, why don't you get ahead of the ball on this one and get off of the drug before it is pulled from the market.
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.
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Beware of Meridia -- Italy Already Pulled it Off the Market