FDA Seizes Two GlaxoSmithKline Medications Over Manufacturing Problems at Puerto Rico Facility
FDA officials on Friday announced that the agency has ended distribution of the antidepressant Paxil CR and the diabetes medication Avandamet, both manufactured by GlaxoSmithKline, because of problems at a manufacturing facility in Cidra, Puerto Rico, that "dragged on for more than two years," the New York Times reports. FDA seized millions of tablets of the two medications from the Cidra facility, as well as distribution facilities in Tennessee and Puerto Rico, because GSK could not "assure the public that its products are properly made," according to the Times.
FDA first detected the problems in February 2002, when inspections of the Cidra facility found that tablets of Paxil CR, the controlled release version of the medication, tended to split in half during production (Harris, New York Times, 3/5). FDA officials said that patients who took the half that contained the active ingredient would receive an uncontrolled dose and that those who took the inactive half would miss a dose. In addition, FDA said that the active ingredient in Avandamet was not properly distributed throughout the tablets manufactured at the Cidra facility.
FDA said that although the manufacturing problems "aren't thought to pose a health risk" to patients, they "could result in potential risks," the Wall Street Journal reports (Schaefer Munoz/Whalen, Wall Street Journal, 3/7). FDA recommended that patients who take Paxil CR and Avandamet should continue to use their current supplies and discuss alternatives with their physicians until the medications return to the market.
GSK said that the manufacturing problems only involved low-dose versions of Avandamet, although FDA has seized all versions of the medication. FDA did not seize the immediate release version of Paxil (Clarke, Los Angeles Times, 3/5). FDA said that many alternatives exist for patients who take Paxil CR and Avandamet (New York Times, 3/5).
FDA Associate Commissioner for Regulatory Affairs John Taylor said, "FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing. Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner. American consumers deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products" (Wall Street Journal, 3/4).
An unnamed FDA official said, "We felt that we had been working with the firm for a couple of years now, and although they have made some progress in correcting the problems we felt that without our intervention we couldn't get them to where they needed to be."
GSK spokesperson Nancy Pekarek said that company officials had thought they had resolved FDA concerns about problems at the Cidra facility. GSK recalled many of the tablets manufactured at the facility before November 2004 and inspected those produced after that time.
According to Pekarek, a new inspection process used by GSK ensured that only undamaged tablets were shipped to pharmacies. Pekarek added that the manufacturing problems were not likely to injure patients.
However, an unnamed former top GSK official said, "You cannot just say you'll pick out the bad ones. We're not making strawberries here."
GSK officials did not provide details on when or how the company would address the problems at the Cidra facility (New York Times, 3/5). According to the Journal, FDA "will attempt to ensure" that GSK addresses the manufacturing problems "as soon as possible" (Wall Street Journal, 3/4).
GSK officials said that the FDA seizures of Paxil CR and Avandamet likely would cause shortages of the medications (Los Angeles Times, 3/5). However, James McCough, a professor of psychiatry at the University of California-Los Angeles, said, "Most patients who are currently receiving Paxil CR" -- about 450,000 in the United States each month -- "could easily switch to generic versions of Paxil without any loss of benefit" (New York Times, 3/5).