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DANGEROUS DIET AND WEIGHT LOSS PRODUCTS (Part I): The Ingredient PPA and Meridia/Sibutramine Diet Pills.Nov 1, 2003 Physicians, nutritionists, and other health care professionals have always maintained that the safest and most efficient way to lose weight is to eat right, exercise regularly, and maintain a healthy lifestyle. Yet each year, in the battle to lose unwanted pounds and keep them off, over 17.2 million Americans resort to using questionable over-the-counter (OTC) diet and weight loss products which contain amphetamine-like active ingredients such as guarana, phenylpropanolamine (PPA), chromium picolinate, pyruvate, chitosan, and ephedra, which was the subject of last month’s Newsletter. Millions more turn to prescription diet pills of various types which have their own potentially dangerous side effects.
Many OTC and prescription diet products and pills, however, can cause much more harm than good. While the Food and Drug Administration (FDA) regulates the manner in which a manufacturer can advertise a specific diet medication, there is still an alarming degree of what is known as “off-label use” of these products. This occurs when doctors improperly prescribe medications for inappropriate periods of time, in excessive dosages, or for conditions for which the medication is not approved or may even be contra-indicated.
Although many of these products have been available for quite some time, recent medical evidence has shown that OTC diet and weight loss products can have a significant negative impact on blood pressure, metabolism, and general health. The list of side-effects associated with many dietary supplements include: nervousness, restlessness, insomnia, high blood pressure, fatigue and/or hyperactivity, heart arrhythmias and palpitations, congestive heart failure or heart attack, stroke, headaches, dry mouth, vomiting, diarrhea and/or constipation, intestinal disturbances, tightness in chest, tingling in extremities, excessive perspiration, dizziness, disruption in menstrual cycle, change in sex drive, hair loss, blurred vision, fever and urinary tract problems, tremors, confusion, hallucinations, shallow breathing, renal failure, convulsions, and even death. The longer one uses diet OTC weight loss products, the greater the possibility becomes of suffering one or more of these harmful side-effects or adverse reactions.
Prescription diet pills also come with a host of potentially dangerous side effects and adverse reactions of their own. Depending on the particular type of medication involved, these include; heart and/or organ damage, elevated blood pressure, heart attack, stroke, and death.
In addition to the risks one might be exposed to when deciding to embark on a weight loss program which relies exclusively on OTC products or prescription medications is the medical fact that, once such programs are discontinued, the weight lost is almost always regained. In fact, in many cases, the weight gained after discontinuing use actually exceeds the weight that was lost.
This Newsletter will be published in two parts. This first part will discuss the dangers and health risks associated with the ingredient phenylpropanolamine (PPA) found in dietary and weight loss supplements, and the prescription appetite suppressant, Meridia/Sibutramine. Next month, Part II will deal with numerous other OTC products, prescription medications, and numerous dietary “gimmicks” such as supplements, herbal teas, fat burners, Asian diet pills, chromium, picolinate, chitosan, pyruvate, guarana, laxatives, and diuretics.
Phenylpropanolamine (PPA) in Diet Pills
Phenylpropanolamine, also called PPA, was long used as an ingredient in dietary aids and appetite suppressants. (It has also been used in OTC cold remedies and nasal decongestants.) At its height in popularity it was found in Dexatrim, Acutrim, and Permathene weight control products. For a full list of products containing PPA please visit www.phenylpropanolamine-ppa.com.
PPA is similar to an amphetamine in that it increases heart rate and stimulates the cardiovascular system. While PPA has been around for over 50 years, its dangers have only recently become more apparent and understandable. Moreover, it is now believed to have little, if any, value as a weight loss product.
PPA is a vaso constrictor which means that it causes a narrowing of blood vessels so that less blood is able to flow through at a time. Restricted blood flow heightens pressure in the blood vessels and, in certain individuals; this may cause one or more vessels to rupture and bleed uncontrollably. If this occurs in the brain, it causes what is referred to as a hemorrhagic stroke which may, in turn, lead to death.
PPA usage came under increased scrutiny as a result of a study conducted at Yale University that was designed to identify dangers associated with PPA. The test subjects included men and women, ages 18 to 49, who were hospitalized due to hemorrhagic stroke after taking a PPA product. (For each of these subjects a control subject was also recruited.) A subject was classified as “exposed to PPA” if they reported use within three days of the stroke. The study found that certain people who use PPA are 15 times more likely to suffer a hemorrhagic stroke as nonusers, and that first-time users were three times as likely to suffer a stroke. Women between the ages of 18 and 49 appeared to be at an elevated risk of stroke as well.
Since 1979 there have been about 30 published reports of brain hemorrhaging related to PPA ingestion. Between 1965 and 1990 the FDA claims that there were 142 serious reactions to PPA usage including high blood pressure, headaches, strokes, and eight deaths. Each year as few as 200 and as many as 500 people suffer PPA-related strokes in the United States alone.
As a result of numerous reports of health injury and even death associated with PPA usage, the FDA announced a recall on PPA in over-the-counter products in November of 2000. Interestingly, most of the products which included PPA as an ingredient were re-formulated and re-marketed without PPA by the very same companies under the very same names. This makes one wonder why PPA was ever included as an active ingredient in the first place.
If you are concerned that you have taken or are currently taking any products which might contain PPA, including any weight loss medications, appetite suppressants, cold and cough medicines, or nasal decongestants, stop using them immediately and consult a physician. Also, when shopping for any of these products, be sure to read the label or look for a statement that the product is “PPA FREE.”
Meridia (or Sibutramine) weight loss pills are prescription-only appetite suppressants which were designed for either short-term or long-term weight management for obese and severely overweight individuals. About 20,000 prescriptions for Meridia are filled in the United States each week. Like any weight loss pills, Meridia should not be used to substitute healthy eating or exercise. It should only be used in conjunction with a consistently healthy lifestyle including regular exercise and frequent medical monitoring.
Meridia, which was designed to affect neurotransmitters in the brain and to decrease appetite, raises levels of chemicals in the nervous system such as serotonin, dopamine, and norepinephrine. Some of the more common and least problematic side-effects include; dry mouth, sleepiness, irritability, upset stomach or constipation.
Unfortunately, Meridia may also significantly increase blood pressure and heart rate in certain people. Since most Meridia users suffer from obesity and are therefore already prone to elevated heart rate and high blood pressure, the introduction of an amphetamine such as Meridia will only increase the risk of a serious adverse reaction or harmful side-effect.
Even prior to its approval in early 1997, the FDA Advisory Committee voted 5-4 that the benefits Meridia did not outweigh its risks. Since Meridia’s introduction to the market in 1997 there have been over 5,000 reports of adverse health reactions including 306 cardiac events, 152 hospitalizations and 29 deaths. Last year, the consumer watchdog organization, Public Citizen, asked the FDA to bring charges against Abbot Laboratories, the makers of Meridia, on the grounds that the company illegally withheld information regarding the death of a Meridia user as well as other significant risk information that should have been made available to the public.
Public Citizen also requested that the FDA ban Meridia after its usage was suspended in Italy because of two deaths related to cardiovascular complications. In the United Kingdom and France there have been a total of 103 serious adverse reactions including two deaths in the UK. The drug, which is available in 70 countries and has been taken by over 8.5 million people worldwide, is also suspected of having caused deaths in Switzerland and South Africa.
Studies have shown that Meridia may facilitate weight loss for obese individuals but that the weight loss tends to “plateau” after about a year with a loss of about 10% of the starting weight. Thus, a 250 pound person, who is 100 pounds overweight, should only anticipate a 25 pound weight loss after a regimen of Meridia. Regaining the lost weight (and then some) is also a very real possibility.
Therefore, it is clear that the potentially serious, or even deadly, health risks associated with Meridia far outweigh the rather limited weight loss to be anticipated after taking the drug for an extended period of time. Moreover, people using the drug are prone to the same disregard of proper medical monitoring as associated with other potentially dangerous prescription drugs.
Some things to take into consideration when dieting:
People who are seeking to lose weight should do so by: making sensible choices as to the types of food that they eat; carefully monitoring the size of the portions they consume; and undertaking a regular exercise program that takes into consideration their level of fitness and any health problems from which they may be suffering. Before beginning any weight loss program you should always consult your physician, especially if you are severely overweight, looking to lose more than 100 pounds, or suffer from any serious health problem such as high blood pressure, diabetes, heart disease, or liver or kidney disease. You should certainly avoid taking weight loss drugs whenever possible especially if:
* You are pregnant or are breastfeeding;
* You have a history of drug or alcohol abuse;
* You have a history of an eating disorder;
* You have a history of severe depression or manic-depressive disorder;
* You are taking a monoamine oxidase (MAO) inhibitor or any other type of anti-depressant medication;
* You get migraine headaches and take medications for them;
* You have an unstable medical condition, such as glaucoma, diabetes, high blood pressure or heart disease or a heart condition such as irregular heartbeat.
If you are currently taking any weight loss or diet medications and feel as if you may be addicted to them, consult your physician immediately to seek help. Some side effects associated with withdrawal include:
* Noticeable mood swings;
* Insomnia and nightmares;
* Stomach cramps or pain;
* Severe irritability;
* Listlessness or extreme fatigue;
* Nausea or vomiting;
It is not a secret that America is a nation that suffers from an epidemic of obesity. “Fast food,” a sedentary life style, a high standard of living, the wide availability of labor saving devices and other factors that either increase food consumption (“supersize” portions, buffets, etc.) or reduce physical activity (video games, over reliance on automobiles, etc.), have left us with a problem of monumental proportions. The problem is even more acute when it comes to children and teenagers who have been indoctrinated into a culture of excess. It is only natural that those afflicted by severe weight problems and the debilitating illnesses associated with obesity want to lose weight as quickly and effortlessly as possible. Unfortunately, this has lead to a sudden increase in “fad” diets, questionable weight loss products or “folk” remedies, and under-tested prescription drugs, many of which we will discuss next month.
In the meantime, if you or a loved one suspects that a prescription weight loss medication or OTC product has caused an injury of any type, do not hesitate to contact Parker & Waichman for a free case evaluation at www.yourlawyer.com.