FDA News Digest
June 26,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- First Generic Version of Cholesterol Drug Zocor
Approved
-- HIV Treatment OK'd for Patients Not Responsive to
Other
Drugs
-- Plan Set to Modernize Clinical Trial, Patient
Protection
Oversight
-- Guidelines Aim to Prevent Toxins, Allergens from
New Plant
Types
»
Recalls/Safety
Alerts
»
Upcoming Public
Meetings
» Question of
the Week
____________________________________________
NEWS
First Generic Version of Cholesterol Drug Zocor
Approved
FDA has approved the first generic version of Zocor
(simvastatin), a drug to treat elevated cholesterol and other fatty substances
in the blood such as triglycerides. In the United States, Zocor is the second
most widely prescribed drug in the "statin" category of cholesterol-lowering
medicines. FDA says Zocor's "generic version can bring significant savings to
the millions of Americans with [elevated
cholesterol]."
HIV Treatment OK'd for Patients Not
Responsive to Other Drugs
FDA has approved Prezista for adults infected with HIV
who have not responded to treatment with other antiretroviral drugs. It is
intended to be taken with ritonavir, another HIV drug. FDA says the new
treatment is not a cure but "one more major step" in battling HIV and
AIDS.
Plan Set to Modernize Clinical Trial,
Patient Protection Oversight
FDA has announced the Human Subject Protection and
Bioresearch Monitoring Initiative, created to strengthen the agency's
oversight of data integrity and patient protection in clinical trials. The
modernization effort was prompted by the evolution of clinical trials, as
they have become larger, decentralized, and
global.
Guidelines Aim to Prevent Toxins,
Allergens from New Plant Types
FDA has issued guidelines to industry that aim to
prevent the accidental introduction of toxins or allergens into the human and
animal food supply from new plant varieties, including bioengineered types. The
agency emphasizes that it has not found new plant varieties under consideration
for food or feed generally to pose any safety
concerns.
To
view an archive of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go
to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What
is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
________________________________________________________
RECALLS/SAFETY
ALERTS
Animal Product
Recalls:
Pro-Pak with Porcine Meat and Bone, Pro-Lak, and Pro-Amino II,
products used in manufacturing animal
feed
Reason for recall: potential
contamination with prohibited ruminant
protein
Pride
Mature Horse feed; 50-lb. bags
Reason for recall: may contain monensin sodium, which could be
fatal to horses
Food Recalls:
Fast
Bites Spicy Breaded Chicken and Fast Bites BBQ Chicken, distributed in vending
machines and convenience stores
nationwide
Reason for recall: bread may contain undeclared milk
ingredients
G.W.
Strawberry Cake, G.W. Honey Dew Melon Cake, and Asian Taste Dried Sweet
Potato
Reason for recall: undeclared
sulfites
Safety Alert:
FDA is advising consumers not to use the
Triaminic Vapor Patch, a cough suppressant for children over 2. The
patches, which contain camphor, eucalyptus oil and menthol, are intended to
be applied to the throat or chest to allow the vapors to reach the nose and
mouth. But the patches pose a hazard in that children might remove them and
place them in their mouths, accidentally ingesting the patch
ingredients.
For a
list of recalls, market withdrawals, and safety alerts involving
FDA-regulated
products
from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go
to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.
[What is
an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
UPCOMING PUBLIC MEETINGS
July 12 --
FDA Workshop on Testing for Malarial Infections in Blood
Donors
Under
discussion: current information that might support donor testing for malaria as
part of screening
Location: Bethesda, Md.
http://www.fda.gov/cber/meetings/malaria071206.htm
For a list of FDA meetings, seminars, and other
public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________
QUESTION OF THE WEEK
Is buying
prescription medicines online a good
idea?
It can be. But you
should keep these tips in mind:
»
Make sure the site requires a prescription and has
a pharmacist available for questions.
» Buy only from
state-licensed pharmacies. The National
Association of Boards of Pharmacies (www.nabp.info/) has more information about
licensing and its program to certify
online pharmacies.
» Don't provide
personal information such as credit card numbers unless you are sure the site
will protect them.
