black box warning Tagged Articles
FDA approves new drug to treat depression
The Food and Drug Administration (FDA) has approved a new treatment for major depression. Clinical tests of Viibryd, also known as vilazodone hydrochloride, showed that the medication improves the symptoms of major depressive disorder (MDD) in adults.
FDA limits acetaminophen levels, adds warning to prescription drugs
The Food and Drug Administration (FDA) is asking the manufacturers of prescription drugs that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule, and to update their safety labels
A closer look at the study that lead to the banning of Darvon, Darvocet
Late last year the Food and Drug Administration (FDA) banned the drugs Darvon and Darvocet, also known by the generic propoxyphene, from the U.S. market because new data showed that people who used the drug were at an increased risk
Suicides, fatal overdoses also linked to Darvocet, Darvon
Reports of abnormal heart rhythms may have been the serious side effect that led to the removal of the popular prescription painkillers Darvocet and Darvon from the U.S. market. But the drugs have also been linked to an increased risk
Metozolv label has new tardive dyskinesia warning
The new chewable heartburn medication Metozolv, an orally disintegrating version of Reglan (metoclopramide), has added a warning to its label alerting users of a risk of the serious movement disorder Tardive Dyskinesia with long-term use of the drug. The change
Heartburn drugs before pregnancy may increase risk for birth defects
Women who use heartburn medication during pregnancy should not be overly concerned about the drugs causing birth defects, but using the drugs before they become pregnant may cause problems for the unborn child, according to a new study from Denmark
Blood pressure drug may cause injury, death to developing fetuses
The safety label of the blood pressure drug Altace (ramipril) has been updated to include a black box warning against use of the drug during pregnancy as it can cause injury or death to the developing fetus. The labels also
Restless leg syndrome turns out to be movement disorder caused by Reglan
PHOENIX, ARIZONA – Ron, a musician and artist, was having trouble sleeping. His legs would move involuntarily back and forth under the sheets. At first, both Ron and his doctors thought he suffered from restless leg syndrome. But after a
Reglan as morning sickness treatment still carries risks for mom
A study into the safety of the anti-nausea drug metoclopramide, also known as the brand name Reglan, on pregnant women indicates that the drug is safe in mothers and their unborn children, according to a first-time study of the drug’s
Woman blames Reglan for causing her young child permanent disability
Dawn Harris says she was never made aware that long-term use of the acid reflux drug Reglan (metoclopramide) could cause her young child to suffer a serious, permanent and disabling neurological injury that results in involuntary movements of the face,
