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Warning Links Dryvax, Heart Inflammation
By DIEDTRA HENDERSON, AP
WASHINGTON (Nov. 12) - Wyeth Pharmaceuticals Inc. will add black box warnings linking its smallpox vaccine to heart inflammation, the government announced Friday.
Healthy adults given Dryvax vaccine suffered acute myopericarditis - inflammation of the heart and its surrounding sac - says the warning approved by the Food and Drug Administration.
Wyeth spokesman Doug Petkus said the company no longer manufactures or markets the smallpox vaccine. The vaccine had remained in storage since the 1980s. After Sept. 11 domestic terrorist attacks, the government asked Wyeth to test the smallpox vaccine to ensure it was potent.
The black box warnings apply to those vaccines repackaged by Wyeth for immediate use by firefighters, medical personnel and other first responders.
The company had provided nearly 15 million doses for government use, enough to vaccinate up to 8 million people. Government health agencies vaccinated 36,217 civilians. The military has inoculated nearly 680,000 personnel since December 2002. Roughly 13 million smallpox vaccine doses remain in the Centers for Disease Control and Prevention's stockpile.
Because of life-threatening complications associated with existing smallpox vaccines, the government has sought safer new-generation smallpox vaccines to prepare for another terror attack.
In a recent clinical trial comparing Dryvax to an investigational smallpox vaccine, eight confirmed or suspected cases of myopericarditis were detected among 1,162 patients. That means people had a 1 in 145 chance of developing the heart condition after vaccination with Dryvax.
The conclusion followed concerns raised during a 2002-03 Department of Defense vaccination program. Of 540,824 military personnel who received Dryvax, 67 developed myopericarditis - or 1.2 per 10,000 vaccinations. The heart problems developed quickly, in three to 25 days.
Among vaccinated civilians, 21 cases of myopericarditis were reported as of May 9, 2003, according to the FDA.
Col. John Grabenstein, deputy director for military vaccine at the Army Surgeon General's Office, said the Department of Defense has warned about the heart problem since April 2003.
"This is not a new finding. This is paperwork catching up with an old finding," Grabenstein said. While the heart condition is alarming - sending otherwise healthy people to the emergency room with chest pains mistaken for heart attacks - he said it remains uncommon.
People stricken with the heart ailment get better, according to follow-up blood tests, heart exams and exercise stress tests. "Their recovery is very good," he said.
This summer, tens of thousands of troops stationed in the Pacific and the Middle East received mandatory anthrax and smallpox vaccines to protect against biological warfare.
In response to a federal judge's order in late October, the Pentagon halted the mandatory anthrax vaccinations for the military - six shots spaced over 18 months.
Mandatory smallpox vaccinations, not yet challenged in the courts, continue for personnel headed to Afghanistan, Iraq and Korea. In addition, a team of smallpox-vaccinated staffers are assigned to nearly 100 military hospitals and large clinics around the world, Grabenstein said.
On the Net:
Food and Drug Administration: http://www.fda.gov/cber/whatsnew.htm
11/12/04 18:02 EST
Copyright 2004 The Associated Press. The information contained in the AP news report may not be published, broadcast, rewritten or otherwise distributed without the prior written authority of The Associated Press. All active hyperlinks have been inserted by AOL.
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