WARNER-LAMBERT CONSENT AGREEMENT

US drugmaker Warner-Lambert has entered into a consent agreement with the Food and Drug Administration which means it will stop making certain drugs until it can provide evidence that it has improved its manufacturing practices. The company will, however, be permitted to continue making and shipping drugs that are deemed medically necessary and not otherwise available.

Such products include Dilantin (phentytoin), Nitrostat (nitroglycerin), Acupril (quinapril), Lopid (gemfibrozil), Nipent (pentostatin), Zarontin (ethosuximide) and Celontin (mesuximide).

Among the lapses which the FDA found in W-L's manufacturing practices were improperly trained laboratory technicians, the changing of drug formulae without government permission and failure to take action when the drug batches failed laboratory quality tests, according to an FDA spokeswoman. She said the company was selectively filing lab reports on its products, and reports that would have shown drugs were chemically unstable were not filed with the government.