FDA Heparin problems cause unknown
Thu, 28 Feb 2008 23:40:40 GMTWASHINGTON - U.S. inspectors found some mostly procedural problems at a Chinese factory that supplied the main ingredient for the recalled blood thinner heparin — but said Thursday they can't yet tell what is to blame for serious side effects.
"We're still considering all possibilities," said Food and Drug Administration compliance chief Deborah Autor. "We have not ruled anything out at this point."
Baxter International halted production earlier this month after the blood thinner was linked to four deaths and hundreds of reports of allergic-type reactions, including vomiting, nausea and difficulty breathing.
The FDA has completed an inspection of the Chinese factory, Changzhou SPL, that supplied the active ingredient, and took the unusual step Thursday of posting its draft inspection findings on the agency's Web site. The FDA is under intense scrutiny in the probe, after it acknowledged that an agency mix-up meant the Chinese factory had never been inspected before the heparin began selling.
Inspectors compiled a list of possible problems in how workers ensure they're producing quality drug.
Among the findings:
• A lack of specific procedures outlining removal of impurities.
• Workers reprocessed the drug that didn't meet specifications without determining what caused the initial problem.
• No records showing suppliers' source of the products.
• Some apparently improperly cleaned and maintained equipment.
Heparin, used to prevent blood clotting, is generally made from pig intestines. In China and other developing countries, tracing the source of animals used to make it can be difficult.
The FDA stressed that inspectors' initial findings are preliminary and must be further investigated. China isn't the probe's only focus; the FDA also is conducting inspections at facilities in the U.S.
The FDA said Thursday that it now has a total of 448 reports of possible problems in patients taking heparin from any manufacturer, but the agency thinks that those associated with the problematic Baxter product number 215.
Baxter hadn't formally recalled all of the problematic heparin vials because the FDA feared doing so would trigger a shortage. Thursday, Baxter took that next step, after the FDA verified that a second U.S. supplier has ramped up to fill the gap.
Of most concern are vials of heparin used in fairly large doses, such as for heart surgery or during dialysis. But also recalled Thursday, in what FDA said was a purely precautionary move, was Hep-Lock, a very diluted product used to prevent blood clots from forming in intravenous medication lines, because it was made with the same ingredient.
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On the Net:
FDA's Heparin update: http://www.fda.gov/cder/drug/infopage/heparin/default.htm
FDA OKs Nexium in children age 1 to 11
Thu, 28 Feb 2008 23:27:05 GMTWASHINGTON - The Food and Drug Administration has approved use of the drug Nexium in children aged 1 to 11 who have acid reflux disease.
FDA said Thursday it approved liquid and delayed-release capsules of Nexium in doses of 10 milligrams or 20 milligrams for these youngsters. It is already approved in doses of 20 milligrams or 40 milligrams for those aged 12 to 17.
Nexium, manufactured by AstraZeneca of Wilmington, Del., is a type of drug known as a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.
The approval was for short-term use in these children, FDA said. The most common side effects in children were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness, the agency said.
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On the Net:
FDA: http://www.fda.gov
Swiss say fans should get measles shot
Thu, 28 Feb 2008 23:19:27 GMTBy ELIANE ENGELER, Associated Press Writer
GENEVA - Soccer fans and players should take precautions against measles before coming to Switzerland for the European Championship in June, authorities said Thursday. The highly contagious disease has infected more than 420 people this year in the Alpine nation, which is co-hosting with Austria the soccer event that is expected to draw hundreds of thousands of fans and tourists.
"We recommend that those who are not immunized, including the Swiss, get vaccinated," said Jean-Louis Zuercher, a spokesman with the Federal Office of Public Health. Players and teams should also check their vaccine status and get a shot if necessary, he said.
Measles, once a scourge of children in Europe, has become extremely rare in recent decades as a result of vaccination programs.
But a fear of side-effects has led some parents to refuse immunization for their children, a reluctance that Swiss officials blame for an epidemic that began two years ago and infected 1,081 people in 2007.
Dr. Peter Strebel, of the World Health Organization, said there is a risk the disease might spread to thousands of soccer fans and teams who come for the 15 international games Switzerland will host during the Euro 2008.
"There are some studies that have shown transmission in settings like that," he said.
Measles symptoms include high fever, coughing and red skin spots. The fatality rate is low in developed countries, but higher in underdeveloped nations with poor health care.
The disease spreads very easily, jumping from person to person through droplets emitted in sneezing or coughing. But a person becomes immune once infected with the virus or, of course, through vaccination.
Switzerland, one of the world's richest and most developed nations, has a surprisingly low immunization rate of only 86 percent. France, Italy and Portugal — which all are sending teams and thousands of fans to Switzerland — also have coverage of less than 95 percent, which is the national immunization rate recommended by the U.N. health body.
Strebel said the risk of transmission is higher "when a lot of people, especially from different countries, come together and live in accommodation where they may be close to each other, as well as in locker rooms, dressing rooms and in stadiums."
He said he was concerned that the current Swiss epidemic was continuing, especially as the country shares a border with so many others.
European soccer body UEFA, which is organizing the tournament said it was "concerned about this measles epidemic with regard to players and other members of the national associations' delegations."
UEFA will tell team doctors at a meeting in Vienna next month that unvaccinated players and staff should be protected against the virus, the Swiss-based body said in an e-mailed statement.
Zuercher said the same should be recommended of fans.
But, he added, it would be unthinkable to bar soccer fans from entering Switzerland for lack of vaccination.
