Health Highlights: March 29, 2019
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Questions Remain About Safety of Parkinson's Psychosis Drug: Report
There are many unanswered questions about the safety and effectiveness of a drug used to combat hallucinations and delusions in Parkinson's patients, says a report from a drug safety group.
The nonprofit Institute for Safe Medication Practices (ISMP) called for Nuplazid to have stronger warnings on its label for patients and their families, CNN reported.
The U.S. Food and Drug Administration deemed the drug a "breakthrough" medication and gave it an expedited review, with approval granted in 2016. It's the only approved drug for Parkinson's psychosis.
But after the federal government received a high number of reports about deaths among patients taking Nuplazid, the FDA last year conducted a safety evaluation of the drug. The agency said it found no "new or unexpected" risks that weren't already known at the time of the drug's approval and decided that no further action was needed, CNN reported.
However, the ISMP report released Wednesday says documents from the FDA's evaluation of Nuplazid fail to answer a number of questions about the drug's safety and efficacy.
As a result, the "reassurance" from the FDA was not warranted, according to the medical researchers, safety experts and doctors who wrote the report.
The FDA refused to comment on the ISMP report. The agency said "in general the FDA does not comment on individual studies or reports, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect the public health," CNN reported.
The maker of Nuplazid, Acadia Pharmaceuticals, has stood by the drug. The company is under investigation by the Department of Justice for its sales and marketing of the medication.
New First-Line Treatment for Severe Malaria in U.S.
The drug artesunate -- the World Health Organization-recommended first-line treatment for severe malaria -- will become the first-line treatment for severe malaria in the United States, the Centers for Disease Control and Prevention says in a new guidance to health care providers.
It marks a change in U.S. treatment protocol that became necessary after the only Food and Drug Administration-approved intravenous (IV) antimalarial drug in the U.S. -- quinidine -- was discontinued by the maker and will no longer be available.
Currently, artesunate is not FDA approved or commercially available in the U.S., so the CDC will use a special FDA regulatory measure to ensure that IV artesunate is available for treatment of severe malaria.
Starting April 1, health care providers must call CDC's Malaria Hotline (770-488-7788) to obtain the IV artesunate. After a CDC expert confirms that IV artesunate is needed, the drug will be released free of charge to the CDC quarantine station closest to the requesting hospital, which can pick the drug up at the station.
CDC is stocking artesunate at 10 quarantine stations and will work with the stations and hospitals to ensure swift delivery of the drug. There will be a sufficient supply of IV artesunate for treatment of all cases of severe malaria in the U.S., according to the CDC.
In 2017, there were about 219 million cases of malaria worldwide and 435,000 deaths. Each year, an average of 1,700 travelers to countries where malaria is common return to the U.S. with malaria, and that number is on the rise. Of those, about 300 people return to the U.S. with severe malaria, the CDC said.
Woman With 2 Wombs Has Twins 26 Days After Birth of First Child
A Bangladeshi women with two wombs gave birth to twins, 26 days after giving birth to her first child.
Arifa Sultana, 20, gave birth to a boy in late February, said Dr. Sheila Poddar, a gynecologist at Ad-Din hospital in Dhaka, CNN reported.
After that normal delivery, the mother and baby were released from a different Dhaka hospital. Less than four weeks later, she was admitted to Ad-Din hospital.
"She came to the hospital complaining of lower abdominal pain," said Poddar, CNN reported.
An ultrasound revealed that Sultana was pregnant with twins. Poddar performed a cesarean section to deliver the twins, a boy and girl. All three children are healthy.
Sultana's first baby and the twins were conceived and grown in her two separate wombs. Sultana did not get an ultrasound before her first delivery.
"It is not very common to have two uteruses. When the uterus develops, it comes from two tubes and those tubes fuse together. For some women, the fusion does not occur and the dividing wall does not dissolve," said Dr. S.N. Basu, head of obstetrics and gynecology at Max Healthcare hospital in New Delhi, CNN reported.
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Posted: March 2019