Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Benefits of Experimental Cystic Fibrosis Drug Unclear: FDA
It’s unclear whether an experimental combination drug for cystic fibrosis offers any added benefit over the current single-ingredient drug, the U.S. Food and Drug Administration says.
In an online review, the agency said Vertex Pharmaceuticals’ Orkambi helped improve breathing in cystic fibrosis patients, but the benefit was small, the Associated Press reported.
Orkambi is a follow-up to Vertex’s Kalydeco, the first drug to treat the underlying cause of cystic fibrosis. It was approved by the FDA in 2012.
Orkambi combines the active ingredient in Kalydeco with a new drug called lumacaftor. However, the FDA review said it’s unclear if lumacaftor “contributes any added benefit over” Kalydeco alone, the AP reported.
Next Tuesday, an FDA advisory panel will meet to vote on whether the agency should approve Orkambi. The FDA does not have to follow its panels’ recommendations, but often does.
About 30,000 Americans have cystic fibrosis. A person with the disease can expect to live into their early 40s, according to the Cystic Fibrosis Foundation.
——
Blue Bell Knew About Listeria Contamination Two Years Ago: FDA
Blue Bell Creameries knew about listeria contamination in its Oklahoma plant as far back as March 2013, according to Food and Drug Administration investigation findings released Thursday.
Despite knowing about the problem, the company didn’t halt production or issue any recalls until this year when its products were linked to listeria illnesses, including three deaths in Kansas, the Associated Press reported.
There were 17 positive tests for listeria at Blue Bell’s Oklahoma plant between March 2013 and February 2015. The listeria wasn’t found in food at the plant, but in a number of locations around the plant.
Blue Bell said those areas were cleaned, but the FDA said the cleaning wasn’t adequate, the AP reported.
Neither the company nor the FDA has explained why the Oklahoma plant wasn’t closed after listeria was repeatedly found there. The FDA would not reveal who conducted the tests at the plant.
Violations were also found at Blue Bell’s Texas and Alabama plants.
Blue Bell finally recalled all of its products and halted production last month after listeria was found in its ice cream and listeria illnesses and deaths were traced to its products, the AP reported.
In a statement, the company said its facilities remain closed indefinitely as it cleans and sanitizes them. It will be “several months at a minimum” before its ice cream is back in stores, according to CEO Paul Kruse.
—–
FDA Panel to Discuss Twice-Rejected Women’s Libido Pill
An experimental drug meant to increase women’s sexual desire will be discussed by a U.S. Food and Drug Administration advisory panel next month.
The FDA has twice refused to approve flibanserin due to a lack of effectiveness and side effects such as fatigue, nausea and dizziness, the Associated Press reported.
However, Sprout Pharmaceuticals has recruited women’s groups and other supporters to lobby the FDA to approve the pill. They argue that the federal government has overlooked women’s sexual problems for too long.
The advisory panel of outside medical experts will meet June 4. The FDA does not have to follow the advice of these panels, but often does.
Flibanserin is designed to boost women’s libido by targeting brain chemicals linked to appetite and mood. The FDA rejected the drug in 2010 after an expert panel said its benefits did not outweigh its risks, and rejected the drug again in 2013, the AP reported.
Copyright © 2024 HealthDay. All rights reserved.