In preparing the Canadian edition of the September 27 issue, we noticed that the Canadian price for Synthroid is $6.40 (US $4.92) for 100 100-mcg tablets, compared to $52.70 in the US, an extraordinary 10-fold difference. Synthroid may have been reformulated in the US after the FDA in 1997 required all manufacturers of levothyroxine to file new drug applications because of concerns about the potency of various formulations, including Synthroid. The FDA approved Synthroid in 2002. Health Canada found no indication of a quality concern with Synthroid tablets in 2002, but in July 2004 it announced that levothyroxine will be regulated as a new drug there as well, and additional evidence of safety, efficacy and quality may be required.

Questions have been raised in the US press recently about the safety of Canadian drugs. The process of drug approval in Canada is similar to that in the US (D Paul, Int J Med Marketing 2001; 1:224). More than 90% of drugs available in Canada have also been approved by the FDA. Most of these drugs come from the same manufacturers as drugs in the US. Health Canada takes longer on average to release drugs than the FDA does; more than half the drugs discontinued for safety reasons by the FDA between 1992 and 2001 had not been approved for use in Canada (NS Rawson and KI Kaitin, Ann Pharmacother 2003; 37:1403). Websites claiming to sell Canadian drugs, however, may be selling counterfeit drugs from unregulated sources.

Click here to view the free full article.