FDA to USPlabs: Recall adulterated supplement products from the market
SILVER SPRING, Md. — The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.
The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses, and that there is a reasonable probability that the products are adulterated.
The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act by sending such a letter.
“We took this step to ensure that adulterated and harmful products do not reach the American public,” stated deputy commissioner for Foods and Veterinary Medicine Michael Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”
In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58%, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (63%) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants. For a list of products affected, please see the FDA News Release.
In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.
Study: Cough-cold manufacturers’ voluntary label change on pediatric products reduced ER admissions
BURLINGTON, Vt. — The voluntary action taken five years ago by manufacturers of cough and cold medicines — namely to no longer recommend the use of OTC cough-cold products in children under the age of 4 years unless directed to do so by a doctor — has worked, according to a study published Monday online by Pediatrics, the peer-reviewed journal of the American Academy of Pediatrics.
After a voluntary market withdrawal and labeling revision, emergency room visits for adverse events associated with cough-cold medicines declined both among children younger than 2 years and between the ages of 2 years and 3 years relative to adverse event visits for all drugs.
“The data show what we know to be true: Education and proactive efforts to help parents appropriately use over-the-counter pediatric cough and cold medicines are working,” stated Barbara Kochanowski, VP scientific and regulatory affairs at the Consumer Healthcare products Association. “Through education and packaging and labeling improvements, manufacturers are helping parents choose the right medicine, use the right medicine and store medicine appropriately to avoid accidental, unsupervised ingestion — the primary cause of the rare reported adverse events involving these medicines.”
“Our industry is committed to ensuring the safe use and storage of these medicines,” Kochanowski continued. “The CDC study published today shows these industry initiatives to enhance the safety and safe use of these medicines have had an impact on both adverse drug reactions in infants and toddlers, as well as accidental unsupervised ingestions. Already rare, there have been declines in both.”
Among children ages 2 years and younger, ER visits for cough-cold medicines decreased from 4.1% of all visits before the market withdrawal to 2.4% of all visits afterward. Among children ages 2 years to 3 years, ER visits decreased from 9.5% of all visits before the labeling revision announcement to 6.5% of all ADE visits afterward.
Unsupervised ingestions accounted for 64.3% of children less than 2 years old who suffered from an adverse event associated with a cough-cold medicine. And 88.8% of visits involving children ages 2 years to 3 years reported to an ER with an adverse event after the labeling revision announcement.
Survey: Americans practice bad cold etiquette
EAST HANOVER, N.J. — As many as 56% of Americans who suffer from a cough or cold are still working out at the gym, jumping on public transportation and liberally shaking hands, according to a Mondelez survey in support of its Halls brand. And 43% of Americans continue to go to work when they have a cough or cold.
And it’s not just sick people with unhealthy habits. According to the survey, 23% of healthy Americans make no effort to stay away from cough and cold sufferers.
Mondelez accompanied release of the survey with the introduction of Halls Extra Strong Menthol Flavor, a throat drop made with higher menthol levels than the classic flavors (15 mg vs. 5.8 mg). In support of the launch, Mondelez created the web site UnlockYourCool.com, where consumers can enter for a chance to win a prize.
"From our findings, we know that people aren’t practicing good habits. So for those who inevitably fall victim to a cough, Halls can provide temporary soothing relief," stated Farrah Bezner, director marketing, Halls. "Our new Extra Strong Menthol Flavor throat drop can help you let the cool in, when you’re not feeling your best."