FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

Health Forums and pain relief drug review / Health News / FDA Related - Health News, Drug News / FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

Pages: 1

Posted: 13 May 2005 23:10
	Registered User Currently Offline	Posts: 25 Join Date: May 2005
The Food and Drug Administration (FDA) is warning the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns. Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately. FDA is warning consumers that prescription drugs purchased in foreign countries are not regulated by the FDA and do not carry the same FDA assurances of safety, effectiveness, and manufacturing quality as drugs purchased within the United States. Counterfeit versions of Lipitor (a cholesterol-lowering drug), Viagra (a treatment for erectile dysfunction), and Evista (a treatment and prevention medication for osteoporosis in postmenopausal women) can pose significant risks to consumers. Counterfeit Lipitor that contains no active ingredient or not enough active ingredient could present a long-term risk for the various complications of high cholesterol, such as heart disease. The counterfeit product purchased in Mexico was associated with several reports of high cholesterol in consumers who had used the product. Counterfeit Viagra that contains little or no active ingredient would be less effective than a legitimate product or altogether ineffective. Women who take the substandard generic Evista product that contains no active ingredient may be at risk for developing osteoporosis or for having their osteoporosis progress. The "generic Evista" was analyzed by FDA in coordination with the National Association of Boards of Pharmacy and was found to contain no active ingredient. The counterfeit Lipitor and counterfeit Viagra were analyzed by Pfizer, Inc. and were also found to contain no active ingredient. The "generic Evista" product was purchased from Agua Prieta, Sonora, Mexico and is labeled as "Raloxifeno, fenilox, 50 tabletas, 60mg", made or distributed by Litio and labeled as manufactured in Monterrey, Nuevo Leon, Mexico. The label has red triangles across the top and bottom. (See the website noted below for photographs of the products.) Counterfeit Lipitor and Viagra were purchased in the Mexican border towns of Juarez, Los Algodones, Nogales, and Tijuana . The counterfeit Lipitor and counterfeit Viagra products were labeled only in English, whereas legitimate Mexican pharmaceuticals are usually labeled in Spanish. In addition, the counterfeit Lipitor was provided in round white plastic bottles; however authentic Lipitor in Mexico is sold only in boxes of blister packs. FDA and Mexican federal health officials are continuing to work together to address the issue of counterfeit human drug products, especially along our common border. Recently, federal health officials in Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) have undertaken several specific operations to target illegal drugs, including counterfeit drugs, in Mexican drug stores. These operations, throughout Mexico, including the areas that border on the U.S. have resulted in the suspension of 19 pharmacies and the confiscation and recall of over 105 tons of medicines. Reports of suspected counterfeit drugs can be submitted to FDA at http://www.fda.gov/medwatch. For additional consumer information on counterfeit drugs, visit the following websites: FDA Consumer Education for Counterfeit Medicine: http://www.fda.gov/cder/consumerinfo/counterfeit_text.htm Counterfeit Drug Photographs: http://www.fda.gov/bbs/topics/news/photos/border.html

Posted: 17 May 2005 02:05
	Registered User Currently Offline	Posts: 4 Join Date: May 2005
FDA Approves Requip for Restless Legs Syndrome The Food and Drug Administration has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The drug was first approved for Parkinson’s disease in 1997. Restless Legs Syndrome is a condition that affects about ten percent of the population. The disorder is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep. Requip was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS. The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life. The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo. Common side effects of Requip reported in clinical trials include nausea, headache, and vomiting. The label for the drug will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness), and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope (fainting) or symptomatic hypotension (low blood pressure) may occur, particularly during initial treatment or dosing.

Pages: 1