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Italy has just suspended the use of Merida in their country. And legal action is being filed in the US. This is to let you know where to go for that information.
The following article begins with a question, "Is Merida another Fen-Phen?"
Of course if you have read my book on serotonergic medications, "Prozac: Panacea or Pandora? - Our Serotonin Nightmare," you know without any doubt that Merida is most definately another Fen-Phen or Redux. About the only difference is that Merida came with a few (very few, but at least a few) warnings unlike its predecessors Fen-Phen and Redux did.
From the day Merida was approved I have been asking why. Fen-Phen and Redux had just been removed and the FDA was putting another serotonergic drug out just like the two they had pulled. It made absolutely no sense.
What is tragic is that in the meantime at this point NINE MILLION worldwide have taken the drug and suffered damage in varying degrees.
Be sure to note the list of side effects at the bottom of this article and then compare them to your favorite SSRI or SNRI antidepressant. You will be amazed at the similarity in the two lists of cardiovascular effects.
Keep in mind that in the case of Fen-Phen and Redux and heart valve damage it was the resulting increase in serotonin that produced that damage. ANY DRUG THAT INCREASES SEROTONIN HAS THE POTENTIAL TO PRODUCE THAT SAME GUMMY SUBSTANCE THAT BUILDS UP ON HEART VALVES. And who knows where else in the system it builds up and what damage that causes? No one. Because it is not being researched.
Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
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A number of legal actions are now under investigation on behalf of patients who have been prescribed the weight-loss drug Meridia (sibutramine) and who suffered injury from the drug. In some people, Meridia causes a sharp increase in blood pressure or heart rate. Between February, 1998, when Meridia was first marketed in the U.S., and September, 2001, there have been 397 reports in the U.S. of people who suffered an adverse reaction while taking Meridia. Of these patients, 152 were hospitalized and survived while 29 patients died. Of the 29 deaths, 19 were of cardiovascular causes such as heart attacks, including 10 people who were 50 or younger (three of these were women under the age of 30). There were also 143 patients in whom a cardiac arrhythmia was reported. Because these adverse reaction reports are voluntary, the actual numbers may be ten times higher.
Italy recently suspended use of its versions of Meridia because of two cardiovascular deaths. In the U.K. and France, there have been a total of 103 serious adverse reaction reports in people using the drug, including two deaths in Britain. Nine million people have taken the drug worldwide since it went on the market.
Prior to the Food and Drug Administration's approval of Meridia on November 22, 1997, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted five to four that the benefits of Meridia did not outweigh its risks. The FDA medical officer who reviewed the drug also wrote that "sibutramine has an unsatisfactory risk-benefit ratio and therefore this Reviewer recommends non-approval." The concern of both the advisory committee and the medical officer was based on the fact that Meridia significantly increases blood pressure and heart rate in some people.
Early Study Showed Alarming Rate of Side Effects
One study (BPI 852) that the FDA considered prior to its approval of Meridia showed that a much higher percentage of the people taking Meridia, compared to people taking a placebo, suffered various cardiac affects:
Heart palpitations: 3.1% of Meridia users, 1.2% of placebo users.
High blood pressure: 2.1% of Meridia users, 0.8% of placebo users.
Rapid heart rate: 2.8% of Meridia users, 0.5% of placebo users.
Vasodilatation: 2.6% of Meridia users, 0.8% of placebo users.
When the FDA approved Meridia, it announced that "the drug causes a small increase in average blood pressure, and causes a higher increase in some patients. FDA recommends patients taking sibutramine have regular blood pressure evaluations. People with uncontrolled high blood pressure should not take sibutramine. No cases of pulmonary hypertension, a rare but serious side effect associated with the anti-obesity drugs fenfluramine and dexfenfluramine, have been reported in clinical trials of sibutramine. Echocardiograms on patients taking sibutramine did not show more valvular disease than those on placebo."
On November 12, 1999, the FDA changed Meridia's warning label to include the following as adverse effects in patients taking Meridia: "Cardiovascular: angina pectoris, abnormal ECG, arrhythmia, atrial fibrillation, cerebrovascular accident, chest pressure, chest tightness, congestive heart failure, heart arrest, heart rate decreased, hemorrhage, myocardial infarction, sudden unexplained death, supraventricular tachycardia, syncope, torsade de pointes, transient ischemic attack, ventricular extrasystoles, ventricular fibrillation, ventricular tachycardia."
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