Health Highlights: June 9, 2017
Generic Version of HIV Drug Truvada Approved by FDA Birth Control Pills Recalled Due to Danger of Unintended Pregnancy Unknown Opioids in Fake Pain Pills May Be Behind Georgia Deaths Maid-Rite Beef Products Recalled Creation Gardens Beef Products Recalled
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Generic Version of HIV Drug Truvada Approved by FDA
The first generic version of the HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate) has been approved by the U.S. Food and Drug Administration.
The generic drug is approved for the "treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk," according to the FDA.
Common side effects among HIV-1 infected people using the drug in clinical trials included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. HIV-free people taking Truvada for PrEP reported headache, abdominal pain, and weight loss.
When the generic form is used to prevent HIV infection, it "must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use," the FDA said.
It also said that doctors should tell women with HIV-1 not to breast-feed while taking the drug.
Birth Control Pills Recalled Due to Danger of Unintended Pregnancy
One lot of Mibelas 24 Fe birth control pills has been recalled due to a packaging error that could put users at risk of unintended pregnancy, manufacturer Lupin Pharmaceuticals Inc. says.
The recall is for lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg), the Baltimore-based company said.
In this lot, the blister is rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have four non-hormonal placebo tablets as opposed to the active tablets, putting the user at risk for contraceptive failure and unintended pregnancy.
Consumers with the recalled lot should notify their physician and return the product to the pharmacy or place of purchase. For more information, contact the company at 1-800-399-2561.
Unknown Opioids in Fake Pain Pills May Be Behind Georgia Deaths
Counterfeit pain pills -- linked to an overdose outbreak in Georgia that resulted in four deaths --appear to contain two synthetic opioids, state officials say.
One of the opioids is unknown modified type of fentanyl and may be a new drug, according to a Georgia Bureau of Investigation spokesperson, CNN reported.
The second opioid is a known synthetic drug, but it is not being named until a full analysis of both drugs is complete. That could take days, according to Nelly Miles, director of the GBI Office of Public Affairs.
The fake pills resemble the prescription painkiller Percocet and were sold on the street, CNN reported.
More than two dozen people in Georgia are believed to have overdosed on the pills over three days, including the four deaths, according to the Georgia Department of Public Health. But that number may increase as further test results become available, a spokeswoman said.
Maid-Rite Beef Products Recalled
About 174,000 pounds of raw and ready-to-eat beef products are being recalled by Maid-Rite Specialty Foods due to possible undeclared allergens. The products may contain milk, but it is not listed on the labels, the U.S. Department of Agriculture's Food Safety and Inspection Service said.
The products were produced between March 13, 2017 and May 26, 2017 and shipped across the United States and Canada.
Pennsylvania-based Maid-Rite said bread crumbs received from an outside supplier and used in the products may contain milk. There are no confirmed reports of allergic reactions among people who've ate the products, according to FSIS.
Consumers with the recalled items should throw them away or return them to the place of purchase. For more information, call the company at 570-343-4748.
Creation Gardens Beef Products Recalled
Nearly 23,000 pounds of raw ground beef and beef primal cut products have been recalled by Kentucky-based Creation Gardens, Inc. due to possible contamination with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) says.
The products were produced on May 31, June 1 and June 2, 2017 and have the establishment number "EST. 7914" inside the USDA mark of inspection. The items were shipped to food service locations in Indiana, Kentucky, Ohio and Tennessee.
E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 28 days (34 days, on average) after exposure the organism.
Consumers who have the products should be throw them away or return them to the place of purchase, FSIS said.