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FDA warns of dangerous reactions to unapproved respiratory drugs

Two respiratory drugs sold in stores in Spanish-speaking neighborhoods contain illegal drug ingredients that can cause liver failure and severe skin reactions, the Food and Drug Administration (FDA) warns. The drugs Baczol Antigripal and Expectorante, manufactured by the El Salvador company Laboratorios Lopez, are marketed as a treatment for bronchitis, pneumonia and other respiratory infections. They contain sulfamethoxazole and trimethoprim, which have been found to cause liver failure, serious skin reactions and blood cell abnormalities. Some of the drugs also list dipirona on the labels, which is a nonsteroidial anti-inflammatory drug (NSAID) that is not legal in the United States. ... Read More

FDA launches program to stop importation of dangerous, ineffective drugs

The Food and Drug Administration (FDA) has implemented a new pilot program designed to crack down on the import of contaminated, misbranded or unapproved drugs into the United States. The Secure Supply Chain Pilot Program will help ensure the safety of drugs manufactured outside the country, but will also help qualified drug companies in the program by expediting their approval processes so that the agency can focus on drugs not in the program that may need closer inspection to ensure safety. In order to qualify to be in the program, pharmaceutical companies must be the sponsor of a New Drug ... Read More

Lawsuit seeks to cease illegal production, marketing of products from drug company

The Justice Department has filed a lawsuit against a Louisiana pharmaceutical company to stop the sale of drugs that the Food and Drug Administration (FDA) says are labeled incorrectly and have not received federal clearance to be marketed in the United States. Sage Pharmaceuticals, based in Shreveport, has been making and selling prescription painkillers and over-the-counter cold medicines and wound cleansers without FDA approval. The agency says it has been repeatedly warning the company to stop illegally making and distributing the products. In 2000, the government filed an injunction against Sage Pharmaceuticals, to prevent the company from selling two unapproved ... Read More