FDA warns of heart risks from stress-test drugs
Doctors are being warned that two drugs used in cardiacnuclear stress tests can cause heart attacks and deathin patients, the US Food and Drug Administration says.These rare but serious events have led the agency toapprove changes to the labels of Regadenoson andAdenosine and to update recommendations for their use.
FDA approves extended release Hydrocodone painkiller
The US Food and Drug Administration approved Hydrocodone Bitartrate (extended release) for severepain that requires round-the-clock long-term treatment.Citing the potential for opioid abuse or dependency,even if the product is used as prescribed, the agencysaid that the drug should be used only in cases whenother painkillers have proven ineffective.
FDA approves new Antidepressant
USFDA approved vortioxetine, a novel SSRI variant.
Announcing its decision, the FDA noted the drug was
shown to be effective in treating depression in six clinical
trials that compared outcomes in subjects taking the
drug against those of subjects who received a placebo.
The medication will carry a boxed warning alerting
patients and physicians that with children, adolescents
and young adults between 18 and 24, antidepressants
can increase the risk of suicidal thoughts and behavior.
FDA approves Diabetes,
An advisory committee of USFDA voted to approve
Type-2 Diabetes drug Dapagliflozin. The FDA is
scheduled to consider approving Dapagliflozin for sale.
It is also pointed out that both developments are good
for AstraZeneca, the originator, which has experienced
problems with research and drug development that
have left it with few new market entries.
Malaria medication granted
Breakthrough Therapy status
Medscape reported GlaxoSmithKline and the Medicines
for Malaria Venture announced the antimalarial
medicine Tafenoquine recently received Food and
Drug Administration breakthrough therapy status, accelerating its development and review processes. This
medicine could treat the 70-390 million annual cases in
less affluent regions of the world.
FDA approves LDL cholesterol
USFDA approved its elevated low-density lipoprotein
cholesterol treatment, Liptruzet, which combines the
companys Zetia (ezetimibe) and a generic version of Lipitor
(Atorvastatin). A clinical trial showed the combo reduced
LDL cholesterol more than Lipitor alone, but it did not
reduce patients chances of developing heart disease. FDA
approved Liptruzet as a once daily treatment to reduce
low-density lipoprotein cholesterol among individuals who
are unable to control their levels with a healthy diet alone.
FDA approves first Bionic
FDA approved a bionic eye system. The Argus-II Retinal
Prosthesis System, made by Second Sight Medical
Products, is approved for US patients with advanced
Retinitis Pigmentosa, a degenerative eye disease that
can cause blindness. Its not perfect vision, the company
admits, but we are taking blind people back up to low
vision, and that is pretty significant. It took some 20
years and $200 million to get the product this far.
FDA approves first medication of
new class to treat Diabetes
USFDA has approved the first of a new class of medicines
to treat diabetes. The medication, Canagliflozin, will
be sold by Johnson & Johnson and treats patients with
Type-2 Diabetes in a new way, by causing blood sugar to
be excreted in the urine.
FDA approves medication for
USFDA approved Bayer AGs pulmonary hypertension
drug Riociguat for the treatment of two forms of the
condition. The medication is the first to treat, the
form of the condition that lasts six months or longer
often caused by Chronic Thromboembolic Pulmonary
Hypertension. The FDA said the drug is from a class of
drugs called soluble guanylate cyclase stimulators that
help arteries relax to increase blood flow and decrease
blood pressure. The drug will include a boxed warning
advising against its use in pregnant women because of
the potential for fetal harm.