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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior
with Antiepileptic Medications (Jan. 31)
The U.S. Food and Drug Administration today issued new information to
health care professionals to alert them about an increased risk of suicidal
thoughts and behaviors (suicidality) in patients who take drugs called
antiepileptics to treat epilepsy, bipolar disorder, migraine headaches,
and other conditions. [ Read
more ]
FDA
Warns Public of Contaminated Syringes (Jan. 25)
The U.S. Food and Drug Administration (FDA) today announced a nationwide
recall of all lots of heparin and saline pre-filled flush syringes manufactured
by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated
with Serratia marcescens, a bacterium that can cause serious injury or
death. [ Read
more ]
FDA
Issues Early Communication about an Ongoing Review of Vytorin (Jan. 25)
The U.S. Food and Drug Administration today issued an Early Communication
regarding the agency’s ongoing review of Vytorin based on preliminary
results from a recently completed study – the Effect of Combination
Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic
Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE)
– on this cholesterol lowering drug. Vytorin contains both Zetia
(ezetimibe) and Zocor (simvastatin) in one tablet. [ Read
more ]
FDA
Approves New HIV Drug After Priority Review (Jan. 18)
The U.S. Food and Drug Administration today approved etravirine tablets
for the treatment of HIV infection in adults who have failed treatment
with other antiretrovirals. [ Read
more ]
FDA
Warns Public of Possible Botulism Risk (Jan. 18)
The U.S. Food and Drug Administration (FDA) today announced that New Era
Canning Company, New Era, Mich., is expanding its product recall because
of potential Clostridium botulinum (C. botulinum) contamination to all
canned green beans and garbanzo beans distributed by the company nationwide
over the last five years. C. botulinum can cause botulism, a serious and
sometimes life-threatening condition. The affected cans are large institutional-sized
containers, weighing approximately six and a half pounds. [ Read
more ]
FDA
Approves Update to Label on Birth Control Patch (Jan. 18)
The U.S. Food and Drug Administration (FDA) today approved additional
changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label
to include the results of a new epidemiology study that found that users
of the birth control patch were at higher risk of developing serious blood
clots, also known as venous thromboembolism (VTE), than women using birth
control pills. VTE can lead to pulmonary embolism. [ Read
more ]
FDA
Clears for Marketing Real-Time Test for Respiratory Viruses (Jan. 18)
The U.S. Food and Drug Administration has cleared for marketing a test
that simultaneously detects four common respiratory viruses, including
the flu, in a patient’s respiratory secretions. The ProFlu+ test
provides results in as few as three hours. Other diagnostic tests for
respiratory viruses are fast but not as accurate or are accurate but not
as rapid. [ Read
more ]
FDA
Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold
Products (Jan. 17)
The U.S. Food and Drug Administration today issued a Public Health Advisory
for parents and caregivers, recommending that over-the-counter (OTC) cough
and cold products should not be used to treat infants and children less
than 2 years of age because serious and potentially life-threatening side
effects can occur from such use. OTC cough and cold products include decongestants,
expectorants, antihistamines, and antitussives (cough suppressants) for
the treatment of colds. [ Read
more ] [ En
Español ]
FDA
Approves Sealant to Control Bleeding During Surgery (Jan. 16)
On Jan. 2, the U.S. Food and Drug Administration (FDA) expanded the indication
for a liquid fibrin sealant to help control bleeding during general surgery.
Fibrin is a protein that helps blood clot. [ Read
more ]
FDA
Issues Documents on the Safety of Food from Animal Clones (Jan. 15)
After years of detailed study and analysis, the Food and Drug Administration
has concluded that meat and milk from clones of cattle, swine, and goats,
and the offspring of clones from any species traditionally consumed as
food, are as safe to eat as food from conventionally bred animals. There
was insufficient information for the agency to reach a conclusion on the
safety of food from clones of other animal species, such as sheep. [ Read
more ]
FDA
Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease (Jan. 14)
The U.S. Food and Drug Administration has approved Tysabri (natalizumab)
for the treatment of moderate-to-severe Crohn's disease in patients with
evidence of inflammation who have had an inadequate response to, or are
unable to tolerate, conventional Crohn's disease therapies. Crohn's disease
patients using the drug must be enrolled in a special restricted distribution
program called the Crohn's Disease–Tysabri Outreach Unified Commitment
to Health (CD TOUCH) Prescribing Program. [ Read
more ]
FDA
Approves New Genetic Test for Breast Cancer Patients (Jan. 14)
The U.S. Food and Drug Administration has approved a test that helps in
assessing the risk of tumor recurrence and long-term survival for patients
with relatively high-risk breast cancer. The TOP2A FISH pharmDx
is the first approved device to test for the TOP2A (topoisomerase
2 alpha) gene in cancer patients. [ Read
more ]
FDA
Licenses 14 New Blood-Typing Tests (Jan. 11)
On Jan. 10, the U.S. Food and Drug Administration licensed 14 new tests
for determining a person's blood type, a process essential to a safe U.S.
blood supply and safe transfusions. [ Read
more ]
FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs (Jan. 9)
The U.S. Food and Drug Administration (FDA) sent letters warning seven
pharmacy operations that the claims they make about the safety and effectiveness
of their so-called "bio-identical hormone replacement therapy,"
or "BHRT" products are unsupported by medical evidence, and
are considered false and misleading by the agency. FDA is concerned that
unfounded claims like these mislead women and health care professionals.
[ Read
more ]
FDA Commissioner Names Directors to Food Safety and Veterinary Centers (Jan. 4)
Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., is pleased
to announce two major changes in the agency's senior leadership team.
Effective Monday, Stephen F. Sundlof, D.V.M., Ph.D., is moving from director
of FDA's Center for Veterinary Medicine (CVM) to director of FDA's Center
for Food Safety and Applied Nutrition (CFSAN). Bernadette Dunham, D.V.M.,
Ph.D., who is deputy director of CVM, will assume directorship of CVM,
also effective Monday. [ Read
more ]
FDA
Clears First Test Designed to Detect and Identify 12 Respiratory Viruses
from Single Sample (Jan. 3)
The U.S. Food and Drug Administration today cleared for marketing a test
that simultaneously detects and identifies 12 specific respiratory viruses.
[ Read
more ]
FDA
Receives New Data on Risks of Anemia Drugs (Jan. 3)
The U.S. Food and Drug Administration (FDA) is reviewing new data from
two studies that provide further evidence of the risks of anemia drugs
known as erythropoiesis-stimulating agents, or ESAs. The studies show
that patients with breast or advanced cervical cancers who received ESAs
to treat anemia caused by chemotherapy died sooner or had more rapid tumor
growth than similar patients who didn’t receive the anemia drug.
[ Read
more ]
FDA
Clears First Quick Test For Drug-Resistant Staph Infections (Jan. 2)
The U.S. Food and Drug Administration (FDA) today announced it has cleared
for marketing the first rapid blood test for the drug-resistant staph
bacterium known as MRSA (methicillin-resistant Staphylococcus aureus),
which can cause potentially deadly infections. [ Read
more ]
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