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Consumer advocates are demanding that pharmaceutical company Abbot Laboratories take Synthroid (the brand name for levothyroxine sodium) off the market, at least until the Food and Drug Administration (FDA) has had time to evaluate its safety. A group of patient watchdog groups, led by the Gray Panthers, has raised issue with the drug’s effectiveness and safety. A host of problems in 1997 forced the FDA to request that all levothyroxine manufacturers submit new drug applications. Synthroid and other levothyroxine drugs have been on the market for more than 40 years and their manufacturers never had been forced to submit a drug application. Rather than do so now, Abbott opted to submit a "citizen’s petition" asking the FDA to waive the requirement that Synthroid be regulated as a new drug because of the time the medication has been on the market and its proven safety and efficacy.
The FDA refused to grant Abbott’s request in April, citing changes in the medication’s recipe over the years and problems with inconsistent dosing from batch to batch.