Primary Pulmonary Hypertension News - Menu 1st over-the-counter obesity pill to be considered by FDA By MELANIE THOMAS The State News Help may be on the way for the millions of overweight and obese Americans. In an 11-3 vote, a Food and Drug Administration health advisory committee recommended the approval of an over-the-counter weight loss pill. The FDA generally follows the outside panel committee recommendations. The pill, orlistat, would be the only FDA-approved weight loss medication available without a prescription. Orlistat is already sold as a higher-dosage prescription marketed as Xenical. "Other over-the-counter pills are dietary supplements and not FDA-approved for weight loss," GlaxoSmithKline Consumer Healthcare spokesperson Malesia Dunn said. Roughly 127 million adult Americans are either overweight or obese, according to the American Obesity Association. "This (pill) is not for people who want to lose a few pounds," Dunn said. "This is for the consumer that will be committed to weight loss through a gradual and meaningful weight loss program." Dunn added the consumer would have to adopt lifestyle changes such as eating better and exercising. The company still needs the FDA's final approval before it hits the stores, Dunn said. If approved, the pill would be marketed as Alli, she said. Orlistat is unique among other weight loss medications because it does not affect the central nervous system, brain or heart, she said. The pill is taken with meals to help block fat absorption in the body. It will be used to help aid a reduced-calorie diet that contains no more than 30 percent of calories from fat, Dunn said. The pill has been marketed as a prescription drug since 1999, Dunn said. Xenical is a 120 mg capsule and Alli would be 60 mg, she said. "We are excited by the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said GlaxoSmithKline Consumer Healthcare North America president George Quesnelle in a written statement. Olin nutritionist Ronda Bokram said there is no guarantee that when you stop the pill, you will keep the weight off. Bokram also questions the pill's effects if a person's diet is low in fat. "It is important to get to the root of the problem of a person's relationship with food or emotional eating," she said. Bokram added there is no regulation over how much a person can take at each meal. GlaxoSmithKline will recommend the consumer only takes one 60 mg pill per meal. "Their recommendation of one pill is just a liability issue," she said. "They don't acknowledge the misuse of [the pill]." Other prescription and over-the-counter pills have traditionally had a bad reputation in the public's eye. In 1997, fen-phen was taken off the shelves when it was linked to heart valve damage, Bokram said. GlaxoSmithKline's own product, Xenical, has side effects like diarrhea, oily stools and malabsorption, she said. About two years ago the government pulled Ephedra, a common stimulant in dietary supplements aiding weight loss, because it caused an adolescent's death in Illinois, Bokram said. "It is sending the wrong message that you can just take a pill to take care of the problem," Bokram said. Xenical Pronounced: ZEN-eh-kal Why is this drug prescribed? Xenical blocks absorption of dietary fat into the bloodstream, thereby reducing the number of calories you get from a meal. At the usual dosage level, it cuts fat absorption by almost one-third. Combined with a low-calorie diet, it is used to promote weight loss and discourage the return of unwanted pounds. The drug is prescribed for the frankly obese and for merely overweight people who have other health problems such as high blood pressure, diabetes, or high cholesterol levels. Your weight status is determined by your body mass index (BMI), a comparison of height to weight. Most important fact about this drug Along with dietary fat, Xenical decreases the absorption of some fat-soluble vitamins and beta-carotene. To compensate, you should take a multivitamin containing vitamins A, E, D, and K once a day, at least 2 hours before or 2 hours after taking Xenical. How should you take this medication? Take a capsule of Xenical during, or up to 1 hour after, each main meal. You should follow a nutritionally balanced, low-calorie diet that provides no more than 30 percent of its calories from fat. If you miss a meal, or the meal contains no fat, you can skip the accompanying dose of Xenical. --If you miss a dose... Resume taking Xenical at the next meal. Don't try to make up the loss with a double dose. The extra drug won't help. --Storage instructions... Store at room temperature, in a tightly sealed container. What side effects may occur? Side effects of Xenical are more common during the first year of treatment. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Xenical. * More common side effects may include: * Less common side effects may include: Side effects that usually occur after the first year of treatment with Xenical include: depression, leg pain, swollen feet, and tendonitis. Why should this drug not be prescribed? Do not take Xenical if you suffer from "chronic malabsorption syndrome"--a condition that prevents nutrients from passing from your stomach into your bloodstream--or from cholestasis, a blockage in the supply of bile needed for digestion. You'll also need to avoid Xenical if it gives you an allergic reaction. Special warnings about this medication Weight loss begins within 2 weeks and continues for 6 to 12 months. The effect of using Xenical for more than 2 years is still unknown. Side effects such as diarrhea and abdominal pain may be worse if you continue eating a high fat diet or even take a high-fat meal. Limit your fat intake. Your doctor will test your thyroid function before starting you on Xenical to make sure that your weight problem is not due to an underactive thyroid gland (hypothyroidism). Xenical is not an appropriate remedy for this problem. Xenical increases the likelihood of kidney stones. Use it with caution if you have a history of this problem. If you have diabetes, weight-loss is likely to reduce your blood sugar levels. If you're taking an oral diabetes medication or insulin, your dose may have to be reduced. Note that the safety and efficacy of this drug in children have not been established. Possible food and drug interactions when taking this medication If Xenical is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Xenical with the following: Cyclosporine (Neoral and Sandimmune) Special information if you are pregnant or breastfeeding The effects of Xenical during pregnancy have not been adequately studied and the drug is not recommended for pregnant women. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether Xenical appears in breast milk. Do not take it while breastfeeding. Recommended dosage ADULTS Overdosage Adipex-P Pronounced: ADD-i-pecks Why is this drug prescribed? Adipex-P, an appetite suppressant, is prescribed for short-term use (a few weeks) as part of an overall weight reduction program that also includes dieting, exercise, and counseling. The drug is for use only by excessively overweight individuals who have a condition--such as diabetes, high blood pressure, or high cholesterol--that could lead to serious medical problems. Most important fact about this drug How should you take this medication? Take Adipex-P before breakfast or up to 2 hours after breakfast. Tablets can be broken in half, if necessary. Take Ionamin before breakfast or 10 to 14 hours before you go to bed. Ionamin capsules should be swallowed whole. --If you miss a dose... Skip the missed dose completely; then take the next dose at the regularly scheduled time. --Storage instructions... Store at room temperature. What side effects may occur? * Side effects may include: Why should this drug not be prescribed? If you are sensitive to or have ever had an allergic reaction to phentermine hydrochloride or other drugs that stimulate the nervous system, you should not take this medication. Make sure your doctor is aware of any drug reactions you have experienced. Do not take this drug if you have hardening of the arteries, symptoms of heart or blood vessel disease, an overactive thyroid gland, the eye condition known as glaucoma, or high blood pressure. Also avoid this drug if you are agitated, have ever abused drugs, or have taken an MAO inhibitor, including antidepressant drugs such as Nardil and Parnate, within the last 14 days. Special warnings about this medication This drug may affect your ability to perform potentially hazardous activities. Therefore, you should be extremely careful if you have to drive a car or operate machinery. You can become psychologically dependent on this drug. Consult your doctor if you rely on this drug to maintain a state of well-being. If you stop taking this drug suddenly after you have taken high doses for a long time, you may find you are extremely fatigued or depressed, or that you have trouble sleeping. If you continually take too much of any appetite suppressant it can cause severe skin disorders, a pronounced inability to fall or stay asleep, irritability, hyperactivity, and personality changes. Even if your blood pressure is only mildly high, be careful taking this drug. Possible food and drug interactions when taking this medication Remember that this drug should never be combined with the weight-loss drug fenfluramine (Pondimin); very dangerous side effects could result. This drug may also react badly with alcohol. Avoid alcoholic beverages while you are taking it. If Adipex-P is taken with certain other drugs, the effects of either can be increased, decreased, or altered. It is especially important that you check with your doctor before combining this drug with the following: Drugs that boost serotonin levels, such as the antidepressants Luvox, Paxil, Prozac, and Zoloft Special information if you are pregnant or breastfeeding Recommended dosage ADULTS The usual dose is 1 capsule or tablet a day, taken before breakfast or up to 2 hours after breakfast. Some people need only half a tablet each day. Others may find it more effective to take half a tablet twice daily. Ionamin The usual dose is 1 capsule a day, taken before breakfast or 10 to 14 hours before bedtime. CHILDREN Overdosage * Symptoms of Adipex-P overdose may include: Fatigue and depression may follow the stimulant effects of this drug. In cases of fatal poisoning, convulsions and coma usually precede death. Meridia Pronounced: mer-ID-dee-uh Meridia helps the seriously overweight shed pounds and keep them off. It is especially recommended for those who in addition to being overweight have other health problems such as high blood pressure, diabetes, or high cholesterol. It is used in conjunction with a low-calorie diet. Meridia works by boosting levels of certain chemical messengers in the nervous system, including serotonin, dopamine, and norepinephrine. Most important fact about this drug Make a point of keeping follow-up appointments with your doctor. Meridia can increase your blood pressure, so it's important to have your blood pressure and pulse monitored at the beginning of therapy and regularly thereafter. How should you take this medication? --If you miss a dose... Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once. --Storage instructions... Store at room temperature away from heat and moisture in a tight, light-resistant container. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Meridia. * More common side effects may include: * Less common side effects may include: * Rare side effects may include: Why should this drug not be prescribed? Special warnings about this medication Use Meridia with caution if you have uncontrolled high blood pressure; it could make the problem worse. Avoid Meridia completely if you've had a stroke or suffer from heart disease, heart failure, or irregular heartbeat. Also avoid it if you have severe kidney or liver problems; the drug has not been tested under these conditions. Seizures are a rare, but possible, side effect. If you've had seizures in the past, use Meridia with caution. If you have a seizure while taking the drug, stop using it and call your doctor immediately. Any drug that acts on the nervous system can theoretically impair judgment, thinking, and motor skills. Meridia does not seem to have this effect, but caution is still in order until you know how the drug affects you. If you have narrow-angle glaucoma or thyroid problems, make sure the doctor knows; Meridia should be used with caution in these circumstances. If you are prone to gallstones, be aware that weight loss can cause more of them to form. Meridia has not been tested in people under 16 years old. It should be used with caution in those over 65. Although it has been classified as a controlled substance (potentially subject to abuse), the possibility of developing physical or psychological dependence is low. Possible food and drug interactions when taking this medication Remember that Meridia must never be taken within 2 weeks of using an MAO inhibitor such as Marplan, Nardil, or Parnate. The combination could lead to serious, even fatal, overstimulation. Meridia may also interact with a wide variety of other prescription and over-the-counter drugs, especially weight-reducing agents, decongestants, antidepressants, allergy medications, and cough and cold remedies that contain ephedrine or pseudoephedrine. Among the many drugs that pose a potential problem are the following: If you have any doubt about the safety of a combination, be sure to check with your doctor. Special information if you are pregnant or breastfeeding Recommended dosage The starting dose is 10 milligrams once daily. If you have not lost at least 4 pounds after 4 weeks, the doctor may increase the dose to 15 milligrams daily. This is the maximum; if weight loss still fails to appear, Meridia will be discontinued. For those who experience side effects at the 10-milligram level, a 5-milligram dose may prove sufficient. Use of Meridia for longer than 1 year has not been studied. Overdosage Although doctors have had little experience with overdoses of Meridia, increased heart rate and blood pressure are possible results. Since any medication taken in excess can have serious consequences, seek medical attention immediately if you suspect an overdose. FDA APPROVES ORLISTAT FOR OBESITY The Food and Drug Administration has approved orlistat, a new drug to treat obesity. Orlistat is the first drug in a new class of non-systemically acting anti-obesity drugs known as lipase inhibitors. Unlike other obesity drugs, orlitstat prevents enzymes in the gastrointestinal tract from breaking down dietary fats into smaller molecules that can be absorbed by the body. Absorption of fat is decreased by about 30 percent. Since undigested triglycerides are not absorbed, the reduced caloric intake may have a positive effect on weight control. The effects of orlistat on weight loss, weight maintenance, and weight regain and on a number of obesity-related illnesses were assessed in seven long-term multicenter, clinical trials. These studies included about 2800 patients treated with orlistat and 1400 patients treated with placebo. A well-balanced, reduced- calorie diet was recommended for all patient in the weight-loss and weight-maintenance study periods. The diet was intended to decrease caloric intake by 20 percent and to provide 30 percent of calories from fat. In addition, all patients were offered nutritional counseling. Of the patients who completed one year of treatment, 57 percent of the patients treated with orlistat and 31 percent of the placebo-treated patients lost at least 5 percent of their baseline body weight. The recommended dose of orlistat is one capsule with each main meal that includes fat. During treatment, the patient should be on a nutritionally balanced, reduced-calorie diet that contains no more than 30 percent of calories from fat. Orlistat is indicated for obese patients with a body mass index (BMI, a measure of weight in relation to height), of 30 or more, or for patients with a BMI of 27 or more who also have high blood pressure, high cholesterol, or diabetes. A person who is 5’5” in height and weighs 180 pounds would have a BMI of 30. Because orlistat reduces the absorption of some fat-soluble vitamins and beta carotene, patients should take a supplement that contains fat soluble (A, D, E, and K) vitamins and beta carotene. The most common side effects of orlistat are oily spotting, gas with discharge, fecal urgency, fatty/oily stools and frequent bowel movements. Orlistat is manufactured by Roche Laboratories Inc. under the trade name Xenical. |