News for October, 2008

FDA will not name Chinese plants that supplied tainted heparin

The U.S. Food and Drug Administration (FDA) is at odds with congressional investigators over an investigation into the federal agency’s inspection of foreign drug manufacturing facilities.

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FDA inspections of foreign drug facilities could take years

This year’s contaminated heparin scare that seriously harmed hundreds of Americans has taught us one thing – we need a better system of ensuring that drugs manufactured in foreign markets are safe for Americans.

The U.S. Food and Drug Administration (FDA) recently announced that it will place more than 60 food and drug regulators worldwide over the next year to inspect foreign drug manufacturing plants.

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More products made in China recalled for harming infants

Will Chinese products be responsible for more deaths and hardships around the world?

Early last year, more than 80 people died and thousands more were sickened after receiving the heparin. It was later found that specific lots had been contaminated at a manufacturing plant in .

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Despite recall, Baxter International enjoys third-quarter gains

Despite heparin-recall woes earlier in the year, Pharmaceutical drug giant Baxter International announced that it had a 19 percent increase in third-quarter profits, according to a Baxter International press release.

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Pharmaceutical companies developing drugs to fight blood clots

Five pharmaceutical companies are working on new medications to treat blood clots, also known as thrombosis, according to The Wall Street Journal. Thrombosis is a serious problem affecting nearly 900,000 Americans each year, and resulting in nearly 300,00 deaths annually. Currently, heparin and Vitamin K antagonists are the only two principal treatments for blood clots.

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FDA to set up offices worldwide

The U.S. Food and Drug Administration (FDA) will place more than 60 food and drug regulators worldwide over the next year to provide guidance on U.S. quality standards, according to the Associated Press. This will replace the agency’s current practice of sending staffers on individual assignments to inspect foreign facilities.

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High court rule may affect right to sue drug makers

Next month the U.S. Supreme Court will hear a case that could decide whether people harmed by prescription drugs could recover damages for their injuries by suing in state courts. The pharmaceutical industry argues that manufacturers whose drugs are approved by the Food and Drug Administration (FDA) should be protected from liability, according to the Natural News.

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Senator proposes country-of-origin labeling for medications

If Sen. Sherrod Brown (D-OH) has his way, we soon may be able to read the label of prescription medications and learn where they were manufactured. Sen. Brown recently introduced the Transparency in Drug Labeling Act (S. 3633), arguing that Americans have the right to know where their medications are produced, according to Pharmaceutical Technology.

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Artery procedures successfully performed without heparin

A medical study performed at the University of Turin (Italy) has shown favorable results not using the heparin during artery-opening procedures, according to the U.S. News. Heparin is usually used during these procedures.

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Recalled heparin still appearing in hospitals, pharmacies

Just because a drug has been recalled doesn’t mean that it has been eliminated from pharmacy and hospital inventory. According to the Associated Press/San Jose (California) Mercury Sun, during an investigation by the California Board of Pharmacy, heparin, which was recalled last winter, was found 94 times in California hospitals and at least 16 hospitals administered the drug to patients.

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