The FDA announced today that Orlistat, the active ingredient in the prescription diet product Xenical (Roche) and the over-the-counter diet product Alli (Glaxo), will be reviewed for safety. The triggering event was the compilation of 32 reports of adverse events, all of which concerned severe liver disease. Six of them led to fulminant liver failure. Most of the 32 were hospitalized. We offer our readers a general medical perspective and explain why these products are generally safe.
While we are not yet aware of the case reports or the details of the case, some general observations can help to put these risks in perspective. The data includes 32 reports of liver damage related to the use of Orilstat over a period of 9 years. 27 of them were hospitalized. Thirty of these cases were collected outside of Australia and were 120 mg Rx doses. The other two American cases were over-the-counter doses in half. Other adverse events are being investigated. Quality control and consistency of past event reports in Australia may not be sufficient to ensure that they are compiled.
Even without knowing the cumulative number of unit doses sold worldwide in Rx and over-the-counter within almost 10 years, this number must overshadow 32 units from at least six logs, which makes these observations infinitely rare. It is well known that the detection of such rare events must be based on exposure to the market in a large number of users. These cases can represent people with a history of comorbidity or with other impairments.
Drug-induced liver failure is often "idiosyncratic", a nickname that is now thought to be exposure to a toxic metabolite, a genetic predisposition to catabolism, and / or an allergic phenomenon. Although the chameleon-like clinical picture of many drug reactions affecting the liver appears to be a cholestatic reaction, it is an obstruction that is similar to an obstruction of the biliary tract with hepatitis. Although orlistat itself is not absorbed from the intestine, a metabolite (M3) is absorbed, transported to the liver, has a long half-life and is excreted in the biliary system. Genetic deficits in rare people may be required to cause liver toxicity. Alternatively, users of other drugs may experience rare and occasional drug interactions. A third distant idea could involve modulating the orlistat of cell surface receptors required for the entry of the hepatitis C virus.
In this case, the FDA did the right thing by advising the medical community on further analysis of the data. However, this advice can prevent non-prescription consumers from using the product. Given the minimal frequency of liver damage and the likely requirement of a rare accompanying factor, the FDA should prescribe additional warnings on the label of the Rx and OTC versions, but without import. The removal of these products appears to be unjustified and unlikely.
[Dr. Riker is a member of the American Society of Pharmacology & Clinical Therapeutics, the American Society of Pharmacology & Experimental Therapeutics, the Drug Information Association and the American Academy of Allergy, Asthma & Immunology.
Slimming pill - its interaction with other drugs and its relevance to people with high blood pressure
Xenical, an active ingredient in Orlistat, is a medication that is prescribed to treat obesity. It prevents part of the fat absorbed from being absorbed by your body. Xenical is one of the most effective anti-obesity drugs available on the market. It can be combined with a healthy diet and a disciplined exercise program. To determine if you are a Xenical candidate, you can have your body mass index (BMI) checked by your doctor. If you are overweight, Xenical will be prescribed for you.
All medications are precautionary. Xenical is no different and if you are allergic to any of the ingredients in Xenical it is advisable to stay away from it. Xenical blocks fat intake. However, if you have chronic malabsorption syndrome, Xenical is not recommended. To get the most out of Xenical and find out how useful it is for medication, you should tell your doctor about your medical history and your current medication intake. Xenical is not recommended for people under the age of 18 and should never be taken without consulting a doctor.
Risk of interaction with Xenical
Xenical in combination with other medications can have various side effects. For this reason, you should inform your doctor about taking certain medications. If you are taking oral insulin or another oral diabetes medication, Xenical may not be prescribed for you. Medicines such as Gengraf, Sandimmun and Neoral with the active ingredient cyclosporin can interact with Xenical. Caution should also be exercised when taking medicines such as digitalis, lanoxin and lanoxicaps, the active ingredient of which is digoxin. Doctors should also not prescribe Xenical for patients taking medications such as synthroid, levoxyl and levothroid with the active ingredient levothyroxine. If you are taking an anticoagulant like Coumadin that contains warfarin as an active ingredient, you should avoid taking Xenical.
Xenical has been shown to be unsuitable for the above medicines. However, in some cases the dosages can be adjusted so that the patient can take Xenical. Doctors can also perform special regular tests on patients to see if other medications they are taking interact with Xenical. Even if you are taking over-the-counter medications, you should tell your doctor. If you are taking Xenical, you must not take a new medicine without consulting your doctor.
Xenical and high blood pressure
Xenical is safe for people with high blood pressure. When used on a low-fat diet, it helps you get rid of excess weight, which can have some serious health consequences. Xenical can be taken by hypertensive patients. Most importantly, it was found that taking Xenical had a positive impact on their health. Clinical studies with Xenical have shown that in patients with mild hypertension, blood pressure has dropped significantly long before they have actually lost weight.
If Xenical helps you lose weight and you manage weight loss well, you may not need to take antihypertensive drug therapy. This is in cases where you have mild high blood pressure. More than using Xenical, it is actually weight loss that contributes to a drop in blood pressure. Xenical also helps hypertensive patients reduce their medication intake. In some cases, they can even take medication for high blood pressure.
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