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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (2491)	5/15/1998 1:51:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 9523

Bangkok Post - Contraband Viagra now available Reluctance to wait for FDA approval May 15 1998 Aphaluck Bhatiasevi The impotence drug Viagra is being smuggled into the country and sold, on the street and at certain clinics, to people unwilling to wait for Food and Drug Administration approval. The FDA must test and approve all new drugs before they are released onto the market to ensure they fulfil the manufacturer's claims and there are no detrimental effects. Pfizer International Co, the importer, sent samples to the FDA for testing last February, but the approval process normally takes at least a year for drugs of this type. The FDA source said using Viagra without a doctor's prescription could be dangerous, particularly if abused. Possible side-effects include headaches, flushing, indigestion, muscle aches and, in extreme cases, colour blindness. The source also said there was confusion about whether women could use the drug. In America, where it has been approved by the regulatory bodies, Viagra has not been tested on women. The pill works by inhibiting an enzyme called phosphodiesterase, which allows more blood to flow into the penis. The source said several importers had submitted to the FDA samples of other drugs with similar claims. Although Viagra and the other drug called Muse, manufactured by Jenssen, have been approved by the US FDA, it will take at least two years to monitor its safety when used on Thais before being approved by the local FDA, said Siriwat Tiptaradol, deputy director-general of the administration. He said the FDA was considering both drugs. Viagra is taken orally while Muse is inserted into the urethra. Dr Siriwat said even if the two new drugs were approved for sale, they would have to be prescribed because of possible side-effects. The only erectile dysfunction drug that has been registered by the FDA is Caverject, manufactured by Pharmacia, and Upjohn, which is injected. Impotence is on the increase among Thai men, particularly in those over 40, claimed Apichat Kongkanand of Chulalongkorn University's medical faculty. "It is considered a health problem for about 50 percent of men over 50," he said. Dr Apichat described erectile dysfunction as an "illness". Many people, he argued, are under the misconception that it has mental causes, and so avoid going to the doctor. Impotence, he said, is often caused by overuse of drugs such as antibiotics, excessive consumption of alcoholic beverages, and heavy smoking. It is common among people suffering from other health problems like diabetes, cardiovascular diseases, neurological ailments and spinal injuries, he said. Verasing Muangman, president of the Thai Urological Association, said a survey conducted on some 200 men aged 40-70 showed that over 40 percent suffered from impotence. While 30 percent wanted to seek treatment, eight percent felt they could do without consulting a physician, he said. Erectile dysfunction is also found among young adults, said Dr Verasing, but it is often temporary and caused by stress or anxiety. bangkokpost.net Contraband viagra sold in Thailand Friday May 15 8:27 AM EDT BANGKOK, May 15 (UPI) - The impotence drug Viagra is being smuggled into Thailand and sold on the black market to men who are unwilling to await its approval by the Thai Food and Drug Administration. The Bangkok Post says (Friday) the manufacturer of the drug, Pfizer, sent samples to the Thai FDA for testing last February, but the approval process normally takes at least a year. dailynews.yahoo.com