June 1, 2007

Wait Before Using Type 2 Diabetes Drug Januvia, Public Citizen Advises on WorstPills.org

‘Worst Pills, Best Pills’ Subscribers Receive Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market

WASHINGTON, D.C. – Januvia (scientific name sitagliptin), a new drug designed to improve blood sugar control in patients with type 2 diabetes, should not be used because the drug’s long-term safety is still unknown, Public Citizen writes in a new June posting on its WorstPills.org Web site.

Clinical study patients who were given Januvia experienced an increase in the chemical creatinine, which is found in the blood. Increases in creatinine are often an early indicator of kidney problems. Because the drug is new, more serious adverse effects may not become apparent until the drug is used by a large number of patients. Public Citizen advises consumers not to take the drug until after it has been on the market for seven years – in this case, until 2014 – without exhibiting significant health risks.

Diabetes drugs have been under particular scrutiny since a recent study in the New England Journal of Medicine connected the use of the popular diabetes drug Avandia to an increased risk of heart attack. Two and a half years ago, Public Citizen warned people not to use Avandia because it caused heart failure and is less effective in treating the disease than older, better known drugs.

“Individuals with type 2 diabetes should wait seven years before taking Januvia,” said Dr. Sidney Wolfe, director of the health research group at Public Citizen. “They should not be human guinea pigs and risk being harmed by the adverse effects associated with Januvia that may be magnified with time, as they were with Avandia.”

The Food and Drug Administration (FDA) medical officer charged with reviewing Januvia’s success stated that the drug’s performance was only “fairly modest.” Public Citizen maintains that newly marketed type 2 diabetes drugs are often no more potent or effective than the older diabetes drug families: insulin, the sulfonylureas and the biguanides. Because Januvia is not a “breakthrough” drug – one that is significantly more effective than drugs already on the market – Wolfe advises patients with type 2 diabetes to wait to see if it is truly as safe as its manufacturer, Merck, claims.

The June updates to the WorstPills.org Web site also discuss Parkinson’s disease medication Permax (scientific name pergolide) being pulled from the market because of heart valve damage and the diet drug Xenical (scientific name orlistat) – about to become available over-the-counter as Alli – and its connection to gallstones.

Worst Pills, Best Pills is a monthly newsletter available in print and electronic formats through Public Citizen’s Web site, www.WorstPills.org. The article about Januvia will be available free on the site for the next seven days. The site has other searchable information about the uses, risks and adverse effects associated with prescription medications, including all the information contained in Public Citizen’s best-selling book, Worst Pills, Best Pills. More than 200 drugs on the site are listed as DO NOT USE.

Worst Pills is an unbiased analysis of information from a variety of sources, including well-regarded medical journals and unpublished data obtained from the FDA that allow Public Citizen to sound the alarm about potentially dangerous drugs long before they are banned by the federal government. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Baycol, Zelnorm and Propulsid years before they were pulled from the market.

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