The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
Hallucinations or delusions can occur in as many as 50 percent of patients with Parkinson’s disease at some time during the course of their illness. People who experience them see or hear things that are not there (hallucinations) and/or have false beliefs (delusions). The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.
As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis.
In clinical trials, the most common side effects reported by participants taking Nuplazid were: swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state).
For more information, please visit: Nuplazid.
The U.S. Food and Drug Administration today approved the first generic version of Crestor (rosuvastatin calcium) tablets for the following uses:
- in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults;
- in combination with diet for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides;
- either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol.
In the clinical trials for Crestor, the most common side effects reported by participants taking Crestor included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea.
Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm. Women who require treatment with rosuvastatin should be advised not to nurse their infants.
For more information, please visit: rosuvastatin.
Drug Information Update – New Drug Safety Communication on Brintellix (vortioxetine)
The U.S. Food and Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.
Because of the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period.
Health care professionals should check carefully to make sure they have prescribed or dispensed the correct medicine. During the transition to the new name change from Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use. Patients should make sure they have received the correct medicine. Trintellix tablets will look the same as the Brintellix tablets. Those having any questions or concerns should talk to their prescriber or pharmacist.
Brintellix/Trintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder in adults. It is in a class of antidepressants called serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced.
For more information, please visit: Brintellix.
Emilio Dirlikov, PhD; Kyle R. Ryff, MPH; Jomil Torres-Aponte, MS; et al.
MMWR Morb Mortal Wkly Rep 2016;65:(Early Release)
During November 1, 2015–April 14, 2016, a total of 6,157 specimens from suspected Zika virus–infected patients from Puerto Rico were evaluated, and 683 (11%) had laboratory evidence of current or recent Zika virus infection. Of the 683, there were 65 (10%) symptomatic pregnant women who tested positive for Zika. A total of 17 (2%) patients required hospitalization, including five patients with suspected Guillain-Barré syndrome. One patient died after developing severe thrombocytopenia. The public health response in Puerto Rico includes increased capacity to test for Zika virus, preventing infection in pregnant women, monitoring infected pregnant women and their fetus for adverse outcomes, controlling mosquitos, and assuring the safety of blood products.