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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. The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press. The need for careful inspections of foreign drug manufacturing plants has come to the forefront ... Read More

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. However, congressional investigators say inspecting the more than 3,000 drug plants in other countries could take as long as 13 years, according to the Associated Press. In comparison, U.S. pharmaceutical factories are inspected by the ... Read More

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 blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China. Even more were harmed recently when 50,000 children were sickened by milk from China that was contaminated by melamine, a product used in the manufacturing of plastics, fertilizer, paint and adhesives that can be lethal to infants. This, just a year after parents around the world were urged to dig through their ... Read More

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. Baxter International is the world’s largest maker of blood-disease treatments. The company also sells the blood thinner heparin, which last year was recalled after batches of the drug made in the company’s Chinese plant were found to have been contaminated. As a result, more than more than 80 people died and hundreds more were made ill after receiving the tainted heparin. At that time, Baxter was the largest heparin ... Read More

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. The blood thinner heparin made news recently when the FDA recalled batches of heparin after more than 80 people died and several others became ill after receiving heparin. It was later determined that heparin made by Baxter International was contaminated in the company’s Chinese manufacturing ... Read More

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. “We are sending a very clear message to producers: if you want to have access to our market you need to make products that meet our standards of quality,” Health and Human Services Secretary Michael Leavitt was quoted in the story. Leavitt oversees the FDA and other federal health agencies. ... Read More

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. FDA approval isn’t a guarantee of safety. For example, last spring, FDA-approved batches of heparin were recalled after they were found to have been contaminated. The tainted drug killed more than 80 people and sickened hundreds more before the FDA recalled the medication. ... Read More

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. “With more drug companies buying ingredients and producing products overseas, country-of-origin labeling is more important than ever,” Sen. Brown said in a press release. Country-of-origin labeling for active pharmaceutical ingredients was initially proposed last April as part of the Food and Drug Administration (FDA) Globalization ... Read More

Artery procedures successfully performed without heparin

A medical study performed at the University of Turin (Italy) has shown favorable results not using the blood thinner heparin during artery-opening procedures, according to the U.S. News. Heparin is usually used during these procedures. Italian researchers carefully selected 700 of the “lowest risk” patients to participate in the trial. This included patients with single blockages of a heart artery, currently taking two clot-preventing medications such as aspirin and thienopyridine, and with no immediate danger of heart attack. The study found that the incidence of heart damage and bleeding events were lower in the patients who participated in the study, ... Read More

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. Nearly 100 pharmacists and the hospitals they work for were fined $2,000 to $5,000 by the Board of Pharmacy, according to the report. The Food and Drug Administration (FDA) recalled heparin early last year after a large number of patients ... Read More