Fact file: Thalidomide

TORONTO – The German manufacturer of anti-morning sickness drug thalidomide has for the first time apologized to people who were born with congenital birth defects as a result of its use.

If you’re hearing about thalidomide for the first time, or wondering if it’s still sold in Canada, here’s the latest information with data from Health Canada.

What is it?
Thalidomide is a drug that was originally sold as a sleeping aid or to treat morning sickness in pregnant women in the late 1950s and 1960s.

What’s the problem?
In 1960-61, it was linked to birth defects, especially if taken during the first 25-50 days of pregnancy.

Who was affected?
It led to birth defects in around 12,000 babies in 46 countries, with only around 8,000 surviving past their first birthday.

When was it taken off the market?
In 1962, thalidomide was withdrawn from the market by regulators around the world.

Which companies sold it?
German drugmaker Grunenthal, UK-based Distillers Company (Biochemicals) Ltd. – which sold the drug in Australia – and Diageo Scotland Ltd., the successor company to Distillers.

Have there been lawsuits?
Thalidomide lawsuits have been filed internationally, and all three companies have previously paid out settlements, many for millions of dollars. In 2010, the British government officially apologized to people hurt by the drug, after earlier agreeing to pay $31 million to thalidomide’s victims. An Australian woman recently reached a multimillion dollar settlement with the British distributor.

Was it possible to get in Canada after it was banned?
Canadians could get thalidomide through doctors via Health Canada’s Special Access Programme. About 95 per cent of requests in 2009 were for multiple myeloma, and the others were for other cancers and conditions.

Is thalidomide back?
The drug has had a resurgence, after having been found to be effective for several conditions including multiple myeloma, a blood cancer. Thalomid is the brand name sold by Celgene Corporation, and is now licensed in Canada.

Why is it back?
Health Canada’s website says in certain trials in recent years, “thalidomide demonstrated benefits in multiple myeloma patients and is being made available in Canada to treat those patients who are 65 years of age or older.”

They go on to explain that in 1998, “thalidomide was approved by the US Food and Drug Administration (FDA) for the treatment of leprosy. In 2006, a new FDA approval was granted for thalidomide in combination with dexamethasone for the treatment of multiple myeloma. Thalidomide is also approved in other countries including Australia and the European Union.”

How are we managing the risk of birth defects?
Health Canada has “carefully reviewed” data on thalidomide and the drug is only available through a controlled distribution program called RevAid. This means only doctors and pharmacists registered with RevAid can give out the product, and all patients must be registered in the program. Prescriptions only last for a limited number of days and women patients who may become pregnant must have regular checkups to make sure they are not pregnant while taking the drug, and must use two forms of contraception. Patients must also not donate semen or blood during and four weeks after their thalidomide treatment.

With files from The Canadian Press