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Posts Tagged “FDA’s Center for Drug Evaluation and Research”

The FDA has been busy with advisories lately and here is one about buying Accutane online. Apparently Accutane is a bad thing to buy online and based on how it can increase blood pressure you should really talk to your doctor before getting a prescription.

The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online. Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The Web page, http://www.fda.gov/buyonline/accutane, will be positioned as a search result on Google and other search engines when a consumer initiates an online search for the drug under any one of its four names (Isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem, Claravis, and Sotret.) The web page warns that the drug “should only be taken under the close supervision” of a physician or a pharmacist, and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies.

“This Web page is yet another step we’re taking to ensure the safe use of a drug that can provide significant health benefits when used properly, but that can also cause very serious side effects if used without supervision of a health professional,” said Steven Galson, M.D.,M.P.H., Director, FDA’s Center for Drug Evaluation and Research.

FDA and the manufacturers of isotretinoin have put in place special safeguards to reduce the risks of isotretinoin, including a strict distribution program, called iPLEDGE. The aim of the distribution program is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Isotretinoin is available only at a pharmacy that is registered for this distribution program. Additionally, the distribution program is designed to prevent the sale of isotretinoin over the internet. Dispensing must comply with the agency’s risk management requirements.

There are a couple of products that I have recommended in the past to combat and cure acne. The first one is the herbal product Acnezine and the other is the Acne no more program

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Tags: accutane, acne, Acne Treatment, acne_cures, antibiotics, birth defects, director, fda, FDA's Center for Drug Evaluation and Research, Google, herbal product, isotretinoin, online search, pharmacist, physician, search engines, search result, Steven Galson, topical_treatments, U.S. Food & Drug Administration, zits

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The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.

What can the FDA do about crap products?

FDA advises consumers who have used any of these products to discontinue use and to consult their health care provider. FDA encourages anyone experiencing ED to seek guidance from a health care provider before purchasing a product to treat this medical condition.

“These products threaten the public health because they contain undeclared chemicals that are similar or identical to the active ingredients used in several FDA-approved prescription drug products. This risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure,” said Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research.

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Tags: Chemical analysis, chemical ingredients, chemicals, diabetes, dietary supplements, erectile-dysfunction, FDA's Center for Drug Evaluation and Research, heart disease, high blood pressure, illegal products, K. Glavin, levitra, nitroglycerin, non-dietary chemicals, pharmaceutical ingredient, prescription drug products, U.S. Food and Drug Administration, undeclared chemicals, undeclared non-dietary chemicals, United States, viagra

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