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Health
FDA seizes 2 drugs for not meeting standards
Associated Press
Published March 5, 2005
WASHINGTON - Glaxo-SmithKline PLC said consumers may see short-term shortages of two types of its drugs after federal officials seized the drugs from three company facilities Friday.
The Food and Drug Administration found the drug company failed to meet manufacturing standards when producing Paxil CR and Avandamet, and officials seized the drugs from a distribution facility in Knoxville, Tenn., and a manufacturing facility and a distribution facility in Puerto Rico.
Because the Cidra, Puerto Rico, manufacturing site is the only place where the drugs are made, "we would expect that in the short term there may be shortages," said company spokeswoman Nancy Pekarek.
Paxil CR is designed to treat depression and panic disorder. Avandamet treats Type II diabetes.
The FDA did not believe the drugs posed significant health risks to consumers and did not recommend that patients stop taking them. But the FDA wanted to halt the products' distribution until the problems are corrected.
An FDA inspection found Paxil CR tablets could split apart, potentially leaving patients with portions lacking either the active ingredient or the controlled-release effect.
The inspection also found that some Avandamet tablets lacked an accurate dose of one active ingredient.
Glaxo recalled certain batches of the two drugs last month and alerted doctors to the problem.
But failure to recall all of the affected product led to the federal seizure, the FDA said.
Group petitions for cancer drug's removal
WASHINGTON - The consumer group Public Citizen petitioned the Food and Drug Administration Friday to remove a last-chance lung cancer drug from the market.
Iressa, made by AstraZeneca, was approved by the FDA in 2003 for use in advanced lung cancer patients for whom standard therapy is no longer effective.
Studies showed Iressa shrank tumors in some terminally ill patients. But a follow-up study after its approval failed to produce an improvement that was statistically significant, prompting AstraZeneca to stop promoting it and to advise doctors that it had failed to live up to expectations.
The failure surprised the manufacturer, which is trying to determine why things didn't go better. Public Citizen had argued against the drug's approval, questioning its effectiveness and safety.
Study shows more pot users seeking help
WASHINGTON - Treatment rates for marijuana nearly tripled between 1992 and 2002, the government says, attributing the increase to greater use and potency.
Advocates of legalizing marijuana disagreed, saying the trend was largely due to an increase in marijuana arrests and had almost nothing to do with more people seeking treatment because they thought their own health was at risk.
FBI records show a substantial increase in marijuana-related arrests during the decade studied, from about 340,000 in 1992 to about 700,000 in 2002.
The study on treatment rates was conducted by the Substance Abuse and Mental Health Services Administration, which estimated that 41 states had an increase in the number of people who sought treatment for marijuana use during the decade studied. The estimates reflect the number of people who get help at a drug or alcohol treatment center, which can include clinics, hospitals or private doctor's offices, administration officials said.
[Last modified March 5, 2005, 00:42:15]
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