New Drug Update 2009-2010 - LAFP

about PCV2, a contaminant in RotaTeq. Gordon Allan, PhD, a professor at The Queens University Belfast
in Belfast, Northern Ireland, rang an alarm bell with what resembled a passing remark about how the virus
triggers postweaning multisystemic wasting syndrome.
"PCV2 in a lot of ways is a strange virus," Dr. Allan said. To get "good disease in pigs with PCV2," one
must infect them with the virus and then stimulate their immune system, either by reinfecting them with
the virus or vaccinating them. He raised the possibility of this chain of events occurring with sequential
doses of rotavirus vaccine.
May 14, 2010 FDA Revises Recommendations for Rotavirus Vaccines
The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the
prevention of the disease in infants and has determined that it is appropriate for clinicians and health care
professionals to resume the use of Rotarix and to continue the use of RotaTeq.
The agency reached its decision based on a careful evaluation of information from laboratory results from
the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input
from scientific and public health experts, including members of the FDA’s Vaccines and Related
Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.
The FDA also considered the following in its decision:
• Both vaccines have strong safety records, including clinical trials involving tens of thousands of
patients as well as clinical experience with millions of vaccine recipients.
• The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known
to cause infection or illness in humans.
• The benefits of the vaccines are substantial, and include prevention of death in some parts of the
world and hospitalization for severe rotavirus disease in the United States. These benefits
outweigh the risk, which is theoretical.
March 28, 2010 FDA warns that of the 4 million prescriptions for nitroglycerine tablets sold in the
US last year, that most were not FDA approved nor was their safety or effectivenss vetted by the
FDA.
The FDA notified the two major unapproved manufacturers Glenmark Generics and Kronec tthat they had
not meet the rules of the FDA and that they should discontinue manufacturing in the nest 90 days and
marketing of these unapproved nitroglycerine tablets in the next 6 months. The companies said that they
would comply but they took issue with the FDA saying that these products were pre 1938 FDA regulations
and thus grandfathered and not required for FDA review. The FDA has not evaluated these products but
they are NOT FDA approved and thus we are ordering them off the market. Pfizer’s Nitrostat is the only
FDA approved nitroglycerine tablet and it is priced slightly above the other two $21.99 vs. $19.99
May 2010 FDA Action against Johnson and Johnson and McNeil Consumer Healthcare
Ingredients used by Johnson & Johnson in some of the 40 varieties of children's cold medicines recalled
last week were contaminated with bacteria, according to a report by the Food and Drug Administration.
Agency officials said Tuesday none of the company's finished products tested positive for the
contaminants, though such testing is not definitive. "We think the risk to consumers at this point is
remote," said Deborah Autor, director of FDA's drug compliance office. The FDA report, which was posted
online, lists more than 20 manufacturing problems found at the McNeil Consumer Healthcare plant in Fort
Washington, Pa., where the formulas were made. The recalled products include children and infant
formulations of Tylenol, Motrin, Zyrtec and Benadryl. FDA inspectors visited the plant in mid-April and
wrapped up their inspection Friday. J&J issued its "voluntary" recall later that night. Among other
problems, FDA inspectors said the company did not have laboratory facilities to test drug ingredients and
failed to follow up on customer complaints. J&J did not investigate more than 46 complaints received in
the last year about "black or dark specks" in Tylenol products, according to the FDA's report. Additionally,
inspectors found some pieces of equipment covered with thick layers of dust, while others were held
together with duct tape. In a statement Tuesday, J&J called the problems cited by the FDA "unacceptable
to us, and not indicative of how McNeil Consumer Healthcare intends to operate." The FDA reiterated that
serious medical problems with the products are unlikely, but advised consumers to stop using the
medicine as a precaution. Parents are instructed to use generic alternatives instead. J&J has said some
of the recalled medicines may have a higher concentration of the active ingredient than listed on the
bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet
testing requirements. "That warning letter brought us to the point where we thought it was necessary to sit
down with management and discuss our concerns," Autor said. FDA officials said they are considering
taking additional action against J&J, ranging from issuing more warning letters to pursuing criminal action.
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