U.S. officials Friday seized batches of GlaxoSmithKline's diabetes drug Avandamet and controlled-release antidepressant Paxil CR because of concerns over manufacturing quality.
The U.S. Food and Drug Administration saw no immediate risk to consumers from the two drugs made by Europe’s biggest drugmaker but said the manufacturing failed to meet standards for safety, strength, quality and purity.
Patients were advised to continue taking their medication but talk to their doctor about possibly using alternative drugs until the manufacturing problems are corrected.
“FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing,” said John Taylor, FDA Associate Commissioner for Regulatory Affairs.
The European Medicines Agency said no recall of products was envisaged in Europe at present. Glaxo had informed the agency that none of the batches seized had been supplied to the European market.
Resolve problems quickly
The FDA found that Paxil CR tablets could split, possibly giving patients a portion lacking any active ingredient or active ingredient without controlled release.
In addition, some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient.
Glaxo said it was working to resolve manufacturing problems as quickly as possible but said both drugs would be in short supply in the United States in the short term.
The seizures were executed by the U.S. Marshals Service at GlaxoSmithKline’s Cidra, Puerto Rico manufacturing facility, and a distribution facility in Knoxville, Tennessee and one in Puerto Rico, the FDA said.
There have been FDA inspections for some time at the Cidra plant, as Glaxo highlighted when it announced full-year results last month. The factory is the only source of supply of both drugs for the U.S. market.
The facility also makes a number of other medicines, including heart failure treatment Coreg, but the spokesman said they were not affected by the move and the FDA was not investigating other product lines.
The European Medicines Agency said European officials would soon inspect Glaxo’s Puerto Rico factory.
