Diabetes drug pulled from shelves

By DANN OKOTH and ELIZABETH MWAI

The Government has withdrawn a popular drug used to treat Type 2 diabetes from the market just days after the European Union banned it and the US restricted its use.

diabetes drug, Avandia, made by British company GlaxoSmithKline increases the risk of heart problems which could lead to heart attacks. The Government also suspended the sale of Glaxo’s other diabetes drugs, Avandamet and Avaglim, since they too contain rosiglitazone.

In an exclusive interview with Panorama, the Head of Pharmacovigilance Department at the Pharmacy and Poisons Board Jayesh Pandit says it halted the sale after reviewing data pertaining to the safety and risk profile of the drugs.

"The board has written to the manufacturer suspending the market authorisation license with immediate effect until evidence is made available to the board supporting the safety and efficacy related data outweighing their risks," says Dr Pandit.

Licences

In a letter to doctors, Pandit wrote: "We are advising you that clinicians with patients who are currently on rosiglitazone regimens be shifted to alternative treatments. These products will be recalled and quarantined under our supervision."

Assistant Registrar Fred Sioyi says the board has suspended the licenses of the three distributors of Avandia. It has also directed GlaxoSmithKline, and Glenmark and Torrent who circulate the generic types to stop further distribution.

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In an Interview with Panorama, Dr Sioyi confirms the board has instructed doctors and institutions prescribing the drugs to stop immediately.

Sioyi says the suspension of Avandia, which has been in use in Kenya for the past 10 years, will remain in effect awaiting the decision of the review panel and practice committees set to sit next week. "The review panel on safety issues could not meet this week as members were outside Nairobi," he says.

Although the board reacted quickly to keep the medicines from pharmacies, critics cited lack of proper drug surveillance in the pharmacology sector that could put million of lives at risk.

Experts including professors teaching at the Biochemistry and pharmacology department at University of Nairobi faulted the Government terming its action to withdraw the drugs as reactionary rather than proactive.

"For how long will we rely on Western governments to act before we do for our own safety," asked a professor from University of Nairobi.

slap warning

Close to 15 million people report to public health facilities every year across the country withdiabetes related complications.

Last week the European Medicines Agency (EMA) recommended that the widely used diabetes drugs, be pulled from European markets due to health concerns. Avandia "will stop being available in Europe within the next few months", the regulator said in a statement last Thursday.

The announcement came as the US Food and Drug Administration (FDA) decided to severely restrict the use of Avandia, but stopped short of an outright ban.

The drug has long been associated with an increased risk of heart attack and stroke, and an FDA study in 2007 linking the medication to serious health concerns prompted authorities to slap a warning on it.

The EMA said it had taken the decision to pull the drug in Europe due to concerns over the drugs active substance rosiglitazone. "The EMA today recommended the suspension of the marketing authorisations for the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim," said a statement from EMA.

But GlaxoSmithKline said it believed Avandia remained an "important treatment", and was working with the EMA and FDA to try and find a solution to the concerns.

Sioyi says following international concerns regarding the side effects of Avandia it was highly unlikely that the suspension would be lifted. He says the committees will either revoke or suspended the drugs indefinitely which means withdrawal of distributors licences until they gather sufficient scientific evidence showing the drug is not harmful.

Sioyi said Kenya had decided to follow Europe Medical Regulators decision of total withdrawal, due to the low literacy among citizens. He says US regulators recommended restriction in prescription as their population there was more educated.

In Kenya, the drug was licensed in 2000 following an upsurge of diabetes .

The EMA said the Europe-wide suspension would remain, unless there was "convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks". The decision has yet to be adopted by European Commission to become legally binding on all EU member states.