An old version of a thyroid medication went back on sale in France on Monday after thousands of the country's three million users complained of serious side effects from a new formula.
France was the first country where the new version of Levothyrox became available, and its German maker Merck Serono has said it is set to be approved in other European countries.
More than 9,000 people in France reported side effects from the drug -- which went on sale in March -- including cramps, headaches, dizziness and hair loss.
A petition for the restoration of the old formula attracted nearly 300,000 signatures, and several lawsuits have been launched.
The new version was developed in 2012 by Merck at the request of French drug safety watchdog ANSM, which was concerned over its short expiration date.
An investigation has been opened into complaints over the drug, which treats underactive thyroids.
It is also used following surgery for cancer of the thyroid, a gland in the neck which regulates the body's metabolism.
The old version is being imported from Germany under the name Euthyrox, ANSM said.
But it noted that the drug was available only in limited quantities, urging doctors to prescribe it as a "last resort".
Merck does not intend to resume production of the old version.
Health Minister Agnes Buzyn announced on September 15 that the old drug would be restored, while alternatives would be made available within a month.
ANSM said one such alternative, L-Thyroxin Henning, produced by French giant Sanofi, would be available by mid-October.
An old version of a thyroid medication went back on sale in France on Monday after thousands of the country’s three million users complained of serious side effects from a new formula.
France was the first country where the new version of Levothyrox became available, and its German maker Merck Serono has said it is set to be approved in other European countries.
More than 9,000 people in France reported side effects from the drug — which went on sale in March — including cramps, headaches, dizziness and hair loss.
A petition for the restoration of the old formula attracted nearly 300,000 signatures, and several lawsuits have been launched.
The new version was developed in 2012 by Merck at the request of French drug safety watchdog ANSM, which was concerned over its short expiration date.
An investigation has been opened into complaints over the drug, which treats underactive thyroids.
It is also used following surgery for cancer of the thyroid, a gland in the neck which regulates the body’s metabolism.
The old version is being imported from Germany under the name Euthyrox, ANSM said.
But it noted that the drug was available only in limited quantities, urging doctors to prescribe it as a “last resort”.
Merck does not intend to resume production of the old version.
Health Minister Agnes Buzyn announced on September 15 that the old drug would be restored, while alternatives would be made available within a month.
ANSM said one such alternative, L-Thyroxin Henning, produced by French giant Sanofi, would be available by mid-October.
