All Eyes on Alli vs. Obesity Match-Up – Over-the-Counter Weight Loss Drug That Packs a Punch

The launch of Alli (Orlistat) – the first FDA-approved over-the-counter anti-obesity drug – is exciting news for millions of obese and seriously overweight Americans. Alli, which is expected to hit drugstore shelves this summer, is comprised of a reduced-strength formula of the popular weight-loss drug Xenical (orlistat) and is the only weight-loss drug endorsed by the U.S. Food and Drug Administration and made available without a prescription.

Pharmaceutical giant and Alli manufacturer GlaxoSmithKline maintains the product rights to Alli through mutual agreement with Roche, the manufacturer of prescription-only Xenical. Xenical has a steady safety record and has proven to be moderately effective in helping obese individuals lose weight. Studies indicate that when patients take prescription Xenical in combination with a weight-loss program, patients lost an average of 12.4 pounds of weight less in six months — about double the amount lost by patients taking a placebo weight loss drug. Some studies have suggested that Alli, at half the dosage (and approximately one-third the price of prescription Xenical,) is almost as effective.

How it Works

Alli is made of the same chemical structure as Xenical. The drug obstructs dietary fat from being absorbed by the body after food consumption. The undigested fat is then removed from the body as bowel waste. As such, the drug it leads to a reduction in the absorption of fat by as much as 30%.
Alli will be available in 60 milligram capsules, to be taken three times a day with meals that contain fat. Officials at GlaxoSmithKline said that the drug works by “blocking about 25 percent of the fat in food a person eats. Because of the way it works, Alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal.” GlaxoSmithKline also reported that the drug helps people lose 50 percent more weight than dieting alone. Alli will cost consumers $12 to $25 a week.
“This is the only FDA-approved, over-the-counter weight-loss drug product,” Dr. Charles J. Ganley, the FDA’s director of the Division of Over-The-Counter Drug Products, said during a teleconference. “There are some products, primarily dietary supplements, that make weight-loss claims and those are not FDA-approved, although they are permitted to make these claims.”

Alli vs. The U.S. Obesity Epidemic

The FDA’s approval of the first over-the-counter drug for weight loss comes as the United States and other Western nations are struggling with an unprecedented obesity epidemic. According to the U.S. National Center for Health Statistics, 30 percent of American adults 20 years of age and older — more than 60 million people — are obese. An Additional 36 percent of Americans are considered overweight.

But is Alli the magic diet pill that dieters have been asking for? Maybe not, according to some researchers. Dr. Raj Padwal, an assistant professor of general internal medicine at the University of Alberta, is unsure of about the efficacy of the drug. “People may only lose 1 to 2 kilograms (2.2 to 4.4 pounds) on this half-strength dose [of Xenical]. Whether that is worthwhile is questionable,” said Padwal. “The occasional patient may benefit, but many patients may not. For those patients who need extra incentive to adhere to a low-fat diet, the drug may help.”

Alli is likely to cause very limited direct harm, but may also cause limited good, according to Dr. David L. Katz, an associate professor of public health and director of the Prevention Research Center at the Yale University School of Medicine. “[Alli] is a relatively ineffective weight-loss aid,” he said. “If availability of the drug distracts people from the tried-and-true approach to weight control – eating well and being active – then the FDA decision could prove more harmful than helpful, in spite of good intentions.”

Side Effects

According to research and trials, Alli has very few negative side effects. However, users be warned: eating a meal with too much fat while taking the drug can result in bowel changes such as loose stools, according to the FDA. Side effects typically occur in the first weeks of treatment and can be managed by following the recommended diet of about 15 grams of fat per meal, GlaxoSmithKline said. It is also recommended that users take a multivitamin once a day at bedtime because the drug can interfere with the absorption of some vitamins.
Other side effects may include:

o Oily skin spotting

o Gas with discharge

o Fecal urgency

o Fatty or oily stools

o Frequent bowel movements

Before Taking Alli

Prior consultation with a doctor is recommended before taking Alli. Be sure to:

o Tell your doctor or pharmacist if you are allergic to orlistat or any other drugs.

o Tell your doctor or pharmacist what prescription and nonprescription drugs you are taking, especially anticoagulants (”blood thinners”) such as warfarin (Coumadin); medications for diabetes, such as glipizide (Glucotrol), glyburide (DiaBeta, Dynase, Micronase), metformin (Glucophage), and insulin; other medications for weight loss; pravastatin (Pravachol); vitamins such as beta-carotene and vitamins A, E, and K; and herbal products. If you are taking cyclosporine (Neoral, Sandimmune), take it 2 hours before or 2 hours after orlistat.

o Tell your doctor if you have or have ever had anorexia nervosa or bulimia, gallstones, thyroid disease, diabetes, kidney problems, or if you consistently have problems absorbing food (malabsorption syndrome).

o Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.

o Inform your doctor about your medical history including drug or alcohol abuse in order to avert any medical mishap.

Also, people who have had an organ transplant should not take the Alli. Anyone taking blood-thinning medicines or being treated for diabetes or thyroid disease should consult a physician before using the drug, the FDA said.
Is Alli the end-all treatment that will fight the obesity epidemic once and for all? Studies indicate that it may certainly help, yet skeptics are equally as weary about its overall effectiveness. If you are considering taking Alli when it hits the shelves this summer, be sure to consult with your physician first.

Anti Malaria Drug Therapy

Anti Malarial Drug Therapy needs the advice of an expert because of drug resistance, and side effects, and you must do this well before leaving on vacation. This article gives a brief summary of the popular anti malarials, and their potential side effects.

Chloroquine and Proguanil known as Paludrine are the oldest and most widely used. They are safe to take long-term, however, annual eye check-ups are recommended after three years of chloroquine use. The wealth of experience suggests that they are safe to use during pregnancy although it is recommended that folic acid 5 mgs daily is added to the regimen during preg­nancy when proguanil is taken. Unfortunately, there is now widespread resistance to these drugs, rendering them much less effective in some parts of the world.

Depending on the area to be visited, they are either taken alone or together. Travellers should start anti-malarials at least a week before travel, mainly to make sure that they do not react to the medication, continue whilst there and for at least four weeks after leaving a malaria area. The usual adult dose is chloro­quine two tablets once a week together with proguanil two tablets daily, making a total of sixteen tablets per week.

The main side-effects of the chloroquine/proguanil combi­nation, apart from an unpleasant taste, are nausea, stomach upsets and mouth ulcers. Chloroquine should not be taken by people who are currently suffering from epilepsy or have had epilepsy in the past, or by people who suffer from psoriasis, a common skin disorder.

There has been a lot of controversy surrounding the use of mefloquine known as Larium for malaria prophylaxis. Publicity in the media and conflicting medical advice have led to confusion, and subsequently some travellers are not taking any drug prophylaxis at all for countries where it is recom­mended. This could lead to potentially life-threatening malaria infection. Every traveller needs to consider the pros and cons of mefloquine and decide if the drug is suitable for them.

All drugs have side effects, and studies have shown that meflo­quine can cause problems such as dizziness, headache, insom­nia, vivid dreams and depression in a few people, and that these problems seem to affect women more than men. A recent study showed that around a quarter of those people taking mefloquine and an eighth taking chloroquine and proguanil experi­enced problems. Some studies have shown that, in about one in ten people, the side effects interfered with planned activities and in one in 10,000 people a severe side effect occurred.

Some of the side effects experienced with mefloquine, especially headaches and vivid dreams, may be helped by taking half a tablet twice a week. The majority of side effects with meflo­quine start within three weeks of starting the drug and stop within three weeks of stopping. It is recommended that you start mefloquine at least two weeks before travelling so that if any side-effects occur you can change to an alternative drug.

Studies from Africa show that mefloquine is more effective at preventing malaria infection then a combination of chloro­quine and proguanil, 90 per cent compared to 60-70 per cent. Mefloquine is also convenient to take as it is a weekly dose, and it is now licensed to be used for up to one year. However, it is rel­atively expensive. If travellers are tolerating mefloquine and re­main at high risk of malaria infection, it is advisable to continue for 2-3 years. Mefloquine has now been used by over 6,000 Peace Corps workers for 2-3 years without evidence of se­rious adverse reaction.

Mefloquine is first choice for areas where there is widespread chloroquine resistance, such as sub-Saharan Africa, the Amazon basin and parts of South-East Asia. Mefloquine is not suitable for everyone and it is not recommended for the following women in the first 12 weeks of pregnancy, women who are breast-feeding or women who might become pregnant within three months of taking the last tablet. However, evidence is ac­cumulating that women who have taken mefloquine in the early stages of pregnancy, or just prior to becoming pregnant, do not appear to have an increased risk of having a child with congeni­tal problems compared to the background risk.

People with a history of epilepsy or a strong family history of epilepsy. People who have any mental health problems, e. g. depression, anxiety attacks or mood disturbances. People who have cardiac rhythm problems. People whose jobs depend on a high degree of co-ordination, such as airline pilots or professional divers.

It is not suitable for young children under 5 kg. For children between 5-13 kg it is difficult to break up the tablets to get the correct dose, which is 5 mg/kg, since the tablet contains 250 mg of mefloquine, and therefore less than a quarter of a tablet is re­quired. As yet there are no paediatric formulations available. Finally people with liver problems or severe kidney disease.

The third alternative is an antibiotic called doxycycline, a form of tetracycline. This is particularly popular with Australian travellers, but British authorities mainly recom­mend it for travellers to the border areas of Thailand/Myanmar (Burma) and Thailand/Cambodia, as well as the western prov­ince of Cambodia, where falciparum malaria is often resistant to both chloroquine and mefloquine. Studies show that doxycy­cline gives around 85 per cent protection against malaria infec­tion, though this effectiveness quickly falls if compliance is poor. Doxycycline is increasingly being used by the higher risk traveller to sub-Saharan Africa if mefloquine is contra-indicat­ed or if there is a reluctance to take it.

Doxycycline is recommended for short term prophylaxis, for 3-4 months, and concern about possible side effects restricts its use for longer. Balancing these side effects, doxycycline provides good anti-malarial protection and also reduces the incidence and duration of travellers’ diarrhoea.

Doxycycline should not be taken by pregnant women or chil­dren under the age of ten. American recommendations allow its use in children aged eight or over. It should be taken with liber­al quantities of fluid to prevent ulceration and discomfort in the oesophagus. The main side-effect is that some people become very sensitive to the sun and become sunburnt easily. Doxycy­cline interferes with the contraceptive pill and it is recommend­ed that women also use barrier methods of contraception in the first 2 weeks of starting doxycycline. Women taking regular doxycycline maybe prone to recurrent vaginal thrush.

Malarone is a combination of atovaquone and proguanil, and you should not take it if you are allergic to either proguanil or atovaquone. People with kidney disorders, should not take Malarone. The same applies for people suffering from depression, mental illness and epilepsy. If you are pregnant or planning on becoming pregnant, talk to your doctor, but the best advice is probably to stay away from Malaria regions.

Finally even if you have taken every precaution you can think of, if you feel feverish go to a doctor, even if it is some time after you return. You can’t be too careful, and just remember no medication works 100% of the time so don’t forget all the other preventative measures.

Natural Anti Histamine – Quercetin

Quercetin is being referred to as a biological response modifier. When I was first told about this reference I had no idea what it meant. First, it has to be realized that quercetin is a flavonoid and they are generally referred to as nature’s biological response modifiers. This is because flavonoids have an ability to modify the body’s reaction to other compounds, such as viruses, allergens, and carcinogens, as evidenced by their anti-inflammatory, anti-allergic, anti-viral and anti-cancer properties.

Quercetin demonstrates a strong anti-inflammatory activity due to direct restriction of a number of the beginning processes of inflammation. Quercetin restricts both the manufacture and release of histamine and other allergic and inflammatory compounds. Quercetin appears to be useful in virtually all inflammatory and allergic conditions, i.e., asthma, hay fever, rheumatoid arthritis and lupus, and this would include diabetes and cancer.

Quercetin has anti-oxidant properties, and as a flavonoid, it is a very powerful anti-oxidant in giving dramatic protection against oxidative and free-radical damage. Quercetin also exerts a vitamin C- sparing action.

How does quercetin compare to synthetic anti-histamines?

In the United States, synthetic anti-histamines are big business, as these over-the-counter drugs are the major players along with prescription drugs. Anti-histamines and nasal decongestants are used many times to self-treat allergies; generally this only brings a limited success. Synthetic anti-histamines biggest general problem seems to be their mechanism of action. This happens because anti-histamines do not restrict or block the release of histamine. Rather they block the action of histamine at the cellular receptor sites. Because histamine functions in the brain to maintain alertness, anti-histamines generally cause drowsiness; and this is a major side effect. This side effect has caused problems for the drug companies. To overcome this problem, the pharmaceutical companies have developed prescription anti-histamines that do not produce drowsiness but they do have other serious side effects.

There is an obvious need for an effective natural alternative to the synthetic anti-histamines. Quercetin fills the bill. In contrast to anti-histamine drugs that block the binding of histamine to cellular receptors, quercetin research has shown that it restricts the release of histamine to cellular receptors and other inflammatory compounds. When these chemicals are restricted, quercetin greatly limits the allergic/inflammatory response. The bonus is there are no side effects have been reported with quercetin.

DISCLAIMER: I am not a Doctor and do not give medical advice; this is a news report and cannot substitute for the advice of a medical professional.