FDA Bars New Patients From Joining Study of Diabetes Drug Tied to Heart Risks | Pharmaceutical Proce

U.S. federal health officials are barring new patients from enrolling in a safety study of GlaxoSmithKline’s controversial diabetes pill Avandia, a week after a panel of experts ruled that the drug increases heart risks.

The Food and Drug Administration said it issued a “partial clinical hold” on the study to update researchers on the latest concerns about Avandia, which has been under scrutiny since 2007.

Last week a panel of experts voted that the drug appears to increase heart risks, but they ultimately voted to leave the drug on the market because the evidence was not definitive.

The FDA is currently reviewing the panel’s opinions and deciding what action to take.

GlaxoSmithKline said in a statement it would halt recruitment for the so-called TIDE trial and update the study’s chief investigators on last week’s meeting. Patients already in the study will be permitted to continue participating.

The principal investigator of the TIDE trial, diabetes expert Dr. Hertzel Gerstein of McMaster University in Hamilton, was not immediately available for comment on the FDA’s decision.

The London-based drugmaker agreed to conduct the trial in 2007, after safety questions about Avandia were first publicized.

The TIDE study is designed to give a definitive picture of whether Avandia’s heart risks are greater than its chief competitor Actos.

Last week, the FDA’s panel of outside advisers voted 20-10 that the trial should continue if Avandia stays on the market.

However, Avandia’s critics have argued that the trial is unethical since current evidence already shows Avandia is riskier than Actos, which is made by Japan-based Takeda Pharmaceuticals.

In May, Dr. David Juurlink of Toronto’s Sunnybrook Health Sciences Centre and the U.S. patient advocacy group Public Citizen called on the FDA to pull the plug on the trial, saying it would be unethical to ask patients to take a drug