US: FDA Warns Wyeth on Quality at Puerto Rico Plant

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Possible contaminants in headache remedies, hormone replacement therapy and other pills made at Wyeth's  plant in Puerto Rico have not been adequately checked out or corrected, the U.S. Food and Drug Administration said on Tuesday.

In its warning letter to Wyeth, the FDA said a November inspection showed several drugs were not packaged under proper conditions.

These drugs include birth control pills, hormone replacement therapy, headache remedies, depression pills and other medications. The agency also noted that workers failed several times to clear packaging lines of old pills.

Analysts said it was hard to assess fallout from the FDA's warning, but said the letter raised concerns about the company's quality control measures overall.

The FDA warning came on top of a Merrill Lynch downgrade of Wyeth to "neutral" from "buy", sending shares of the drug maker off more than 3 percent to a six-week low.

In a letter posted on its Web site, the FDA blasted Wyeth's quality control unit.

"All of the deficiencies stated above are indicative of your quality control unit's failure to assure that each deviation from your drug manufacturing operations, impacting the identity, strength, quality and purity of your drug products, has been adequately investigated," the agency said.

The FDA said the company violated good manufacturing processes related to a number of drugs including its Triphasil birth control pills, hormone replacement drug Prempro, Effexor depression tablets and several forms of the painkiller Advil.

Wyeth spokesman Doug Petkus said the company had recalled some lots of Triphasil already and was working with the FDA on the problems.

"There have been no reports of any impact on patient safety and product efficacy," Petkus said.

Some of the possible contaminants, such as phenol, came from packaging, he said. "It has no medical risk to patients. It does not affect the efficacy of the product. It migrates from container into product," he said.

Deutsche Bank analyst Barbara Ryan said Wyeth is currently operating under a manufacturing consent decree with the FDA covering two other facilities.

"While it appears that none of the cited problems involve significant problems with any of Wyeth's major pharmaceutical products, it is clear that the FDA is concerned with the overall inadequacy of Wyeth's quality control measures at this facility and the actions undertaken to address these issues," Ryan said in a note to clients.

Prudential analyst Tim Anderson said in a note to clients the warning could result in a delay in products of affected products. It also could delay FDA approval of experimental drugs in the company's pipeline.

The Puerto Rico plant packages but does not make all Prempro headed for the U.S. market. It also packages all Advil for the U.S. market and also makes Advil tablets, according to Wyeth.

Wyeth's shares fell $1.55 to $46.32 in closing trade on the New York Stock Exchange after touching a low of $45.78 in the session. (Additional reporting by Julie Steenhuysen in Chicago)

AMP Section Name:Pharmaceuticals
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