Health Highlights: April 26, 2018
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Safety of Parkinson's Drug Nuplazid Being Reviewed by FDA
The safety of the Parkinson's disease drug Nuplazid is being reviewed by the U.S. Food and Drug Administration.
The drug has been cited as a "suspect" medication in hundreds of deaths reported by health care providers, CNN reported.
Nuplazid, the only drug approved to treat hallucinations and delusions in Parkinson's disease patients, was approved by the FDA despite concerns that not enough was known about its risks.
At a congressional budget hearing last week, FDA Commissioner Scott Gottlieb said he would "take another look" at Nuplazid. The FDA this week told CNN that a review of the drug was launched several weeks ago.
The agency said the decision to review the drug was based on a number of factors, but would not specify those factors. Doctors should not stop prescribing the drug or take patients of it while the safety review is conducted, the FDA said.
Death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who had many medical conditions and often took other medications that can increase the risk of death, according to the FDA.
However, some medical experts say the high number of death reports citing Nuplazid warrant further examination to determine what role the drug may have played, and expressed concern that the drug was approved too quickly, with too little evidence that it was safe or effective, CNN reported.
Doctors Worry as Company Stops Making Cancer Drug Pump
A life-extending drug pump for cancer patients will no longer be available because the manufacturer has decided to stop making it.
The Codman pump is implanted in the abdomen and sends high doses of chemotherapy directly into the liver for cancer that has spread there, typically from colorectal tumors, The New York Times reported.
A pump costs between $7,000 and $11,000 and is used in conjunction with intravenous chemotherapy.
The pumps are made by Cerenovus, a subsidiary of Johnson & Johnson. In a letter dated April 4, the company told doctors that production of the pumps stopped on April 1 "because of significant and multiple raw material supply constraints within the manufacturing process," The Times reported.
Demand was "very low," with sales of about 300 pumps a year in the U.S., according to Cerenovus spokeswoman Mindy Tinsley.
"I don't know what we're going to do," Dr. Nancy Kemeny, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York and a pioneer in using the pump, told The Times.
She said her hospital implanted 146 of the pumps last year, and more than 1,000 pumps overall.
"They've increased survival more than anything else in this disease," Kemeny said.
She said she and other doctors appealed to the company to keep making the pump, but it declined, The Times reported.
The Food and Drug Administration does not have the authority to force companies to sell a specific product, said agency spokeswoman Angela Stark.
A similar pump is made by Medtronic, but approved for use in the spine, not the liver. Kemeny said she hoped the Medtronic pump could be used in her patients, The Times reported.
© 2020 HealthDay. All rights reserved.
Posted: April 2018
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