Matt Cahill, who runs Driven Sports, has received a warning letter from the U.S. Food and Drug Administration (FDA) over concerns about the ingredients in Craze, a controversial workout supplement that is reported to have a methamphetamine-like compound. According to the letter, the agency questions whether several ingredients that are claimed to be from dendrobium orchids actually come from the plant. The FDA says that the proprietary blend of ingredients listed as “Dendrobex” made the product adulterated under federal law, since the agency was not aware of evidence that the ingredient was present in food supply. Additionally, the company never submitted any paperwork to have it permitted as a new dietary ingredient. Continue reading
No state is exempt from abuse reports. According to a study by the Special Investigations Division of the House Government Reform Committee, 5,283 facilities in the U.S. were involved in almost 9,000 instances of abuse over a two-year period from January 1999 to January 2001, Carbonated.tv.com reports. The National Center on Elder Abuse (NCEA) of the Department of Health and Human Services estimates that only 1 in 14 cases of elder abuse ever comes to the attention of authorities.
The European Medicines Agency (EMA) is reviewing the cardiovascular risks of testosterone drugs, MedPage Today reports. Like the U.S. Food and Drug Administration (FDA) the agency is basing its investigation on two recent studies showing that the drugs are associated with a higher risk of heart attack and cardiovascular death. The review was prompted by the Estonian State Agency of Medicines and will be conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Continue reading
Tenants in a Harlem apartment building near the site of last month’s deadly gas explosion are suing their landlord and the city of New York for failing to test for allegedly unsafe levels of toxic substances, including lead and asbestos, inside their apartments.
The suit was filed on Friday in housing court by tenants of the12 apartments in the building at 89 East 116Street. The blast broke windows in their building, and dust and debris settled in the apartments. The explosion destroyed two buildings, 1146 and 1144 Park Avenue, Law360 reports. The Department of Housing Preservation and Development (HPD) initially issued a vacate order for 89 East 116, but rescinded it after finding no dangerous asbestos levels in the air around the building. Continue reading
The Remington firearms company has initiated a voluntary safety recall of certain Model 700 and Model Seven rifles that can fire unintentionally, causing injury and possibly death.
The recalled rifles were manufactured between May 1, 2006 and April 9, 2014 and are equipped with X-Mark Pro, or XMP triggers. An “excess bonding agent being applied in the assembly process,” causes the problem, not the trigger itself, the recall notice says. Remington discovered that these rifles can fire unintentionally, creating a dangerous, possibly fatal, situation. The problem is specific to the XMP trigger only and other Model 700 and Model Seven rifles are unaffected by the recall, Guns.com reports. Rifles made after April 9, 2014 are not subject to recall. Continue reading
Abbott FreeStyle and FreeStyle Flash Blood Glucose Meters, Including those Built into OmniPod Personal Diabetes Manager Get Most Serious Recall Status
A class I recall was issued for Abbott Diabetes Care glucose meters FreeStyle and FressStyle Flash Blood Glucose Meters, including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manage (PDM). The recall, which was initiated on February 19th, was issued due to an error that can cause the meters to falsely give a low blood sugar reading. The Class I recall is the most dangerous recall status, and the FDA states that “Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Continue reading
Device maker Covidien has recalled some of its Pipeline and Alligator brain embolism devices after discovering a potentially lethal problem with the devices’ guidewires.
Covidien identified a problem in the plastic coating on the device’s guidewire; the coating can delaminate and detach from the device, MassDevice.com reports. In a company press release Covidien explained, “Delamination of the PTFE coating could potentially lead to embolic occlusion [blockage] in the cerebral vasculature with the risk of stroke and/or death.” Covidien says that, to date, it has not received any reports of injuries related to the problem. The company has informed the U.S. Food and Drug Administration (FDA) and other regulatory agencies of the recall. Continue reading
The European Medicines Agency (EMA), the European Union’s drug regulators, has announced it will study the benefits and risks of testosterone replacement drugs in light of studies suggesting these drugs increase heart risks for the men who use them.
The agency will issue its opinion about whether authorization to market these medications should be maintained or should be changed, suspended or withdrawn across the group of 28 nations, Bloomberg News reports. Continue reading
A recent series of recalls, including a faulty ignition switch linked to 13 deaths, has led a number of problems for General Motors (GM) Co. Wall Street Journal reports that on Thursday, its estimated costs rose to $1.3 billion. GM’s original estimate was less than a third of the $1.3 billion charge, and this amount is also more than the company’s first quarter profit one year ago. Analysts expect the company will be posting its first quarterly net loss since it emerged from bankruptcy in 2009, WSJ reports. Additionally, the Detroit company has suspended two engineers involved in early decision-making.
GM has recalled 7 million vehicles worldwide since the start of the year. This includes a recall over a faulty ignition switch, which can cause cars to switch out of the “run” position, disabling the engine, air bags, steering, brakes and other safety measures. On Thursday, this recall was expanded to include lock cylinders that may allow keys to fall out while the car is running. GM said it was aware of one injury that occurred from an accident linked to when the key slipped out of the cylinder, causing a car to roll away. Continue reading
A new study questions the effectiveness of Tamiflu (oseltamivir) and Relenza (zanamivir) in preventing or reducing flu symptoms.
Health agency recommendations for the use of antivirals were based in part on findings from trials by drug manufacturers, including GlaxoSmithKline (GSK), Medical News Today (MNT) reports. Cochrane Review researchers hoped to verify the safety and effectiveness of neuraminidase inhibitors, but manufacturers refused to provide full access to clinical trial data, leading the researchers to question whether the risks and benefits of the antivirals have been accurately reported, and whether the drugs should be stockpiled for the treatment of seasonal and pandemic flu. The U.S. has spent over $1.3 billion on reserves of influenza antivirals. Continue reading