The United States became one of the first countries to re-license thalidomide -- 35 years after it banned the controversial drug -- when government health officials authorised it for sale. But the decision by the federal Food and Drug Administration was hedged with unprecedented restrictions aimed at ensuring that there can be no repeat of the thousands of birth defects which turned thalidomide into one of the most notorious drugs of all time, and triggered a legendary 1960s British lawsuit between the victims and Distillers, the UK parent company of the firm marketing the drug.

After months of speculation, the FDA said that thalidomide was an effective treatment for a small number of leprosy patients who suffer from a serious inflammation called erythema nodosum leprosum. However, in authorising the use for this small group there are said to be around 50 cases in theUS each year the FDA imposed a raft of tight restrictions.

Every patient who uses the drug will be required to enrol in a government monitoring programme. The makers of thalidomide, the New Jersey-based firm Celgene, will be allowed to supply the drug only to authorised chemists and dispensers. Women patients will be required to undergo pregnancy tests, and all patients for whom thalidomide is prescribed will be told to use contraception at all times.

However, the FDA said it could not require doctors not to prescribe thalidomide for other appropriate conditions, and it is known that the drug is being tested for possible use in treating Aids-related ulcers and wasting. Thalidomide is quite widely available illegally in the US as an Aids-related treatment, and the FDA acknowledged that it may in due course be prescribed more widely in these and other cases.

Thalidomide was banned worldwide 35 years ago after it was blamed for birth defects in more than 12,000 babies, many of whom were born without armsor legs, and with defective organs. The drug had been prescribed widely during the 1950s and 1960s as a sedative and treatment for morning sickness for pregnant women in 48 countries, including Britain.

Ironically, the FDA won widespread praise at the time because of its work in preventing the drug from going on sale in the United States. A few Americans nevertheless took thalidomide in clinical trials or had it prescribed in other countries. A number of other countries, including Brazil and Mexico, have recently authorised the limited availability of thalidomide.

The Observer News Service