FDA Sends Warning to Supplements Companies
Ten companies that make and distribute dietary supplements containing dimethylamylamine (DMAA) have been sent warning letters for marketing products that lack safety evidence, the U.S. Food and Drug Administration said Friday.
DMAA -- also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract -- is often touted as a "natural" stimulant.
The companies that received warning letters and the names of their products are: Exclusive Supplements for Biorhythm SSIN Juice; Fahrenheit Nutrition for Lean Efx; Gaspari Nutrition for Spirodex; iSatori Global Technologies, LLC for PWR; Muscle Warfare, Inc. for Napalm; MuscleMeds Perfomance Technologies for Code Red; Nutrex Research for Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra, Concentrate, andLipo-6 Black Hers; SEI Pharmaceuticals for MethylHex 4,2; SNI, LLC for Nitric Blast; and USP Labs, LLC for Oxy Elite Pro and Jack3D.
"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven't done that and that makes the products adulterated," Daniel Fabricant, director of the FDA's Dietary Supplement Program, said in an agency news release.
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Bed Bugs Blamed for Monkeypox Scare on U.S. Passenger Plane
Bed bugs, not the monkeypox virus, may have caused the rash on a passenger that resulted in a two-hour quarantine of a Delta Airlines plan in Chicago Thursday.
Monkeypox is a rare and sometimes fatal disease similar to smallpox.
Officers wearing Hazmat suits boarded Flight 3163 to examine and take photographs of the rash on 50-year-old Lise Sievers of Red Wing, Minn., who was returning home from Uganda, ABC News reported.
"Medical staff at CDC and the Chicago Department of Public Health reviewed the case and, based on the patient's symptoms and photographs of the rash, it does not appear that the signs and symptoms are consistent with a monkeypox infection," the U.S. Centers for Disease Control and Prevention said in a statement. "The ill passenger was advised to seek medical care and the rest of the passengers were released from the plane."
"It's just a case of bed bugs," Sievers said after she exited the plane, ABC News reported.
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Holstein with Mad Cow Disease Put Down After Showing Signs of Illness: USDA
A dairy cow in California that was found to have mad cow disease was euthanized after it become lame and started lying down, U.S. Department of Agriculture officials said Thursday.
They also said that the Holstein cow from a dairy farm in Tulare County -- the nation's leading dairy-producing county -- was 10 years and seven months old. That contradicts a spokesman for U.S. Rep. Devin Nunes of California who said Wednesday that the cow was 5 years old, the Associated Press reported.
Routine testing at a transfer facility detected mad cow disease (bovine spongiform encephalopathy -- BSE) in the cow. The animal was never destined for the meat market and posed no threat to the food supply, officials said.
The cow had atypical BSE, which is caused by a random mutation. The last two cases of BSE in the U.S. were atypical as well, the AP reported.
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Don't Use Hepatitis C Drug With HIV Drugs: FDA
The hepatitis C medicine Victrelis (boceprevir) should not be taken with certain ritonavir-boosted HIV protease inhibitor drugs, the U.S. Food and Drug Administration said Thursday.
Taking these medicines at the same time could reduce their effectiveness and allow levels of the hepatitis C virus or HIV in the blood to increase.
Ritonavir-boosted HIV protease inhibitors include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted Prezista (darunavir), and Kaletra (lopinavir/ritonavir).
"Patients should not stop taking any of their hepatitis C or HIV medicines without talking to their healthcare professional. Patients should contact their healthcare professional with any questions or concerns," the FDA said.
"Healthcare professionals who started patients infected with both chronic HCV and HIV on Victrelis while the patient was taking antiretroviral therapy containing one of these ritonavir-boosted protease inhibitors should closely monitor patients for treatment response (no HCV virus detected in the blood) and for potential HCV or HIV virologic rebound (HCV or HIV virus is detected in the blood again after becoming undetectable)," the FDA advised.
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Consumers, Employers to Get $1.3 Billion in Health Insurance Rebates
Under the new U.S. health care law, more than 3 million health insurance policyholders and thousands of employers will receive a total of $1.3 billion in rebates this year, according to a report released Thursday by the Kaiser Family Foundation, a nonpartisan research group.
The law requires insurance companies to spend at least 80 percent of the premiums they collect on medical care and quality improvement or return the difference to individuals or employers, the Associated Press reported.
Insurance companies must notify policyholders about the rebates and pay them by Aug. 1. Some companies have already started issuing rebates.
More than 3 million individual healthy insurance policyholders will receive a total of $426 million, which works out to an average of $127 per person, the AP reported.
On a state-by-state basis, the largest rebates will go to individuals and employers in Texas ($186 million) and Florida ($149 million). Hawaii is the only state in which insurers are not expected to issue rebates.
Rebates totaling $377 million will be sent out to small employers with plans covering nearly 5 million people. Employers are not required to pass their rebates on to workers, and are also allowed to take them as a discount on next year's premiums, the AP reported.
The Kaiser report's findings are based on an analysis of insurance industry filings with state health insurance commissioners.
The rebates are one of the most tangible benefits that consumers have seen to date from the Obama administration's health care law, according to Larry Levitt, a Kaiser Family Foundation expert on private insurance, the AP reported.
However, the insurance industry says new benefits and other requirements of the health care law will likely drive up premiums, negating any consumer benefit from the rebates.
But the Kaiser report said that the new health care law has "provided an incentive for insurers to seek lower premium increases than they would have otherwise," according to the report. "This 'sentinel' effect on premiums has likely produced more savings for consumers and employers than the rebates themselves."
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200 Now Sickened in Tuna-Linked Salmonella Outbreak
A salmonella outbreak linked to a frozen yellowfin tuna product has now sickened 200 people in 21 states and the District of Columbia, the U.S. Centers for Disease Control and Prevention said late Thursday.
In a statement, the agency said 28 people have been hospitalized but there have been no deaths reported.
The CDC says it is now including two types of salmonella in the "outbreak strains" -- Salmonella Bareilly (190 cases) and Salmonella Nchanga (10 cases).
On April 16, nearly 59,000 pounds of tuna product linked to the outbreak -- labeled Nakaochi Scrape AA or AAA -- were recalled by Moon Marine USA Corp. of Cupertino, Calif. The product, which is scraped off fish bones, was sold to grocery stores and restaurants to make dishes such as sushi, sashimi and ceviche.
As reported early in the outbreak by the Associated Press, many people who became ill reported eating raw tuna in sushi as "spicy tuna."
As of Thursday, the CDC said illnesses linked Salmonella Bareilly had been reported in: Alabama (2), Arkansas (1), Connecticut (8), District of Columbia (2), Florida (1), Georgia (9), Illinois (15), Louisiana (3), Maryland (20), Massachusetts (24), Mississippi (2), Missouri (4), New Jersey (18), New York (33), North Carolina (3), Pennsylvania (7), Rhode Island (6), South Carolina (3), Texas (4), Virginia (9), Vermont (1) and Wisconsin (145). Illnesses linked to Salmonella Nchanga had been reported in Georgia (2), New Jersey (1), New York (5), Virginia (1), and Wisconsin (1), the CDC said.
The CDC noted that salmonella illness is often serious for infants, older adults, pregnant women and persons with impaired immune systems, and these individuals should not eat raw or partially cooked fish or shellfish.
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