Health Highlights: July 1, 2013
Start HIV Treatment Earlier: New WHO Guidelines Hobby Lobby Won't be Fined in Birth Control Case FDA Detains Pomegranate Seed Shipments From Turkish Company First Non-Hormonal Treatment for Hot Flashes Approved by FDA
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Start HIV Treatment Earlier: New WHO Guidelines
Antiretroviral therapy for people with HIV should begin sooner than it does now, according to new guidelines released Sunday by the World Health Organization.
Treatment should begin as soon as a patient's CD4 count drops below 500 cells per cubic millimeter of blood, compared with the previous count of 350, The New York Times reported. CD4s are immune system cells that are attacked by HIV, the virus that causes AIDS.
The WHO said some people should begin antiretroviral therapy as soon as they test positive for HIV, regardless of CD4 count. This includes patients with active tuberculosis or hepatitis B liver disease, women who are pregnant or breast feeding, children under age 5, and people whose regular sex partners are not infected.
Many experts recommend that all patients diagnosed with HIV start treatment immediately, regardless of CD4 count. This greatly reduces the risk that they'll infect others and may help them live longer, healthier lives, The Times reported.
Hobby Lobby Won't be Fined in Birth Control Case
Hobby Lobby and the Mardel Christian bookstore chain will not have to pay $1.3 million in daily fines for refusing to provide employees with access to certain forms of birth control.
U.S. District Judge Joe Heaton made the ruling Friday and set a court date of July 19 to hear claims by the companies' owners that having to provide every form of birth control through workers' health care plans would violate their religious beliefs, the Associated Press reported.
The owners object to birth control methods meant to prevent implantation of a fertilized egg in the uterus, such as the morning-after pill or an intrauterine device. However, they are willing to provide employees' with access to 16 other forms of birth control mentioned in the federal health care law.
Heaton said that between now and the hearing, the government cannot impose fines against the companies for failing to comply with the Affordable Care Act, the AP report.
FDA Detains Pomegranate Seed Shipments From Turkish Company
Imports of pomegranate seeds from a Turkish company will be detained by the U.S. Food and Drug Administration because the seeds have been linked to an outbreak of hepatitis A.
The outbreak has sickened 127 people in Arizona, California, Colorado, Hawaii, Nevada, New Mexico, Utah, and Wisconsin and was linked to a frozen food blend called Townsend Farms and Harris Tweeter Organic Antioxidant Blends.
An investigation into the outbreak concluded that the most likely source of the hepatitis A was a shipment of pomegranate seeds used in the frozen food products. The shipment of pomegranate seeds came from Foodstuffs Import Export Trading of Turkey, the FDA said.
The agency said it's working with companies that have distributed pomegranate seeds from this shipment to help ensure that all recipients of these seeds are notified.
First Non-Hormonal Treatment for Hot Flashes Approved by FDA
The first non-hormonal treatment for menopause-associated hot flashes has been approved by the U.S. Food and Drug Administration.
The agency approved Brisdelle to treat moderate to severe hot flashes. The new drug contains paroxetine, a selective serotonin reuptake inhibitor (SSRI) antidepressant sold under the brand names Paxil and Pexeva. Brisdelle is taken once daily at bedtime.
There are a number of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin. Approval of Brisdelle was based on two clinical trials that included a total of 1,175 postmenopausal women and found that Brisdelle was more effective than a placebo at reducing hot flashes. Common side effects included headache, fatigue and nausea/vomiting.
Paxil and Pexeva carry a warning about an increased risk of suicide in children and young adults. Because Brisdelle contains the same active ingredient as those drugs, a warning about suicide risk is included on the new drug's label.
Brisdelle's label also warns about a possible reduction in the effectiveness of tamoxifen if both medications are used together, and an increased risk of bleeding.
Menopause-associated hot flashes occur in up to 75 percent of women and can persist for five years or longer. While not life-threatening, hot flashes can cause discomfort, embarrassment and sleep disruption.
"There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments," Dr. Hylton Joffe, director of the Division of Bone, Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
Brisdelle is marketed by Noven Therapeutics, LLC. of Miami, Fla.