A tornado on Wednesday last week damaged US drugmaker Pfizer’s manufacturing plant in North Carolina, which might affect the supply of a drug used for sedation, but Taiwan has enough in storage to last about four months and an alternative is available, the Food and Drug Administration (FDA) said yesterday.
The company on Friday last week issued a news release saying that “most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance.”
“After an initial assessment, there does not appear to be any major damage to the medicine production areas” the company said, adding that the facility in the city of Rocky Mount is responsible for manufacturing nearly 25 percent of all Pfizer’s sterile injectables.
Photo: AP
Asked if the damage would result in drug shortages in Taiwan, FDA medicinal product division chief Yang Bo-wen (楊博文) yesterday said that only the Precedex 100mcg/ml injection might be affected.
He said the Precedex injection’s active ingredient is dexmedetomidine hydrochloride, which is used for the sedation of intubated and mechanically ventilated patients and peri-procedural sedation of non-intubated patients.
Peri-procedural means soon before, during or soon after a surgical or other medical procedure.
About 9,000 doses of the Precedex injection are used in Taiwan every month, accounting for about 80 percent of the market share, while an alternative generic drug made by a local drugmaker makes up the other 20 percent, Yang said, adding that there are about 36,000 doses of the Precedex injection in storage, which should be enough for four months.
The next shipment of medicine from Pfizer is to be imported next month, but that shipment was stored at a warehouse that was not affected by the tornado, he said.
The shipping date and quantity have yet to be set, he added.
Yang said the FDA would also ask the local drugmaker to increase production of the generic injection, to avoid a possible shortage.
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