MADRID – The Spanish Medicines Agency (AEMPS) has announced that several batches of a drug against osteoporosis have been withdrawn from the market due to a health alert.
The health alert focuses on alendronic acid-cholecalciferol that fights osteoporosis. In particular, there are several presentations of alendronic acid-cholecalciferol manufactured by Pharmathen International S.A and distributed by the STADA laboratory.
According to the agency (AEMPS), the defect is due to an “out-of-spec result in the cholecalciferol test.” Therefore, they are taking the measure to remove from the market all units that have been distributed from affected batches and returned to the laboratory through the usual channels.
Parties involved and expiration date:
ALENDRONIC ACID/COLECALCIFEROL WEEKLY STADA 70 MG/2,800 IU TABLETS EGF 4 Tablets (NR: 83548, CN: 723911)
Batch: 10483, expiration date 31-01-2023
Batch: 10996, expiration date 31-03-2023
ALENDRONIC ACID/COLECALCIFEROL WEEKLY STADA 70 MG/5,600 IU TABLETS EGF 4 Tablets (NR: 83549, CN: 723912)
Lot: 10895, expiration date 28-02-2023
Cholecalciferol, commonly known as vitamin D3, is the component that caused the drug to be discontinued. Moreover, this nutrient helps the body use calcium and phosphorus to build strong bones and teeth.
Osteoporosis is a skeletal disease in which bone mass density decreases. For example, the bones become more porous, the number and size of the cavities or cells in the bones increase, they are more fragile, they are less able to withstand blows and they break more easily.