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Tobacco Companies Try to Win Consumers’ and Regulators’ Trust by Placing Lengthy Warnings on E-Cigarettes

Bigger, direr health warnings are appearing on e-cigarette labels these days.

The warnings on electronic cigarettes (e-cigarettes) are getting longer and more serious compared to the warnings on packages of traditional tobacco cigarettes, The New York Times (The Times) recently pointed out. Per the U.S. Food and Drug Administration (FDA), tobacco cigarettes are only required to have short warnings. A 2009 push by federal regulators to require tobacco companies to create bigger, graphic warnings failed after a successful court challenge from several Big Tobacco companies, according to The Washington Post (The Post). More Tobacco Companies Try to Win Consumers’ and Regulators’ Trust by Placing Lengthy Warnings on E-Cigarettes

Defective Saline Sheaths Prompt Recall of Atherectomy Systems

The U.S. Food and Drug Administration (FDA) announced that Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they contain defective saline sheaths that could fracture during use.

The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted through a catheter into a patient’s blood vessel. The system is intended to reestablish blood flow in narrowed arteries or arterio-venous dialysis shunts. More Defective Saline Sheaths Prompt Recall of Atherectomy Systems

Woman who took Supplement Containing DMMA Experienced Liver Failure

A healthy woman who took three Saba Appetite Control and Energy (ACE) weight loss pills within two days developed liver failure and needed a liver transplant, researchers said.

Two weeks after the 35-year-old woman took the pills she developed jaundice, a yellowish pigmentation of the skin, according to the report from researchers at the University of Kentucky in Lexington, who treated the woman. More Woman who took Supplement Containing DMMA Experienced Liver Failure

Acne Medications can Cause Serious Skin Reactions

The U.S. Food and Drug Administration (FDA) is warning the public that many over-the-counter acne treatments can cause serious and even life-threatening skin reactions.

The FDA released a statement warning that use of certain acne products containing the active ingredients benzoyl peroxide or salicylic acid can cause rare but serious allergic reactions or severe irritation. More Acne Medications can Cause Serious Skin Reactions

FDA Warns of Tainted Weight Loss Supplements

The U.S. Food and Drug Administration (FDA) is warning consumers to not buy or use several tainted supplements promoted for weight loss or body building. Included in the FDA’s warning are: Mix Fruit Slimming; Trim-Fast Slimming Softgel; Lingzhi Cleansed Slim Tea; Sliming (sic) Diet By Pretty White; Lipo 8 Burn Slim; and 24 Ince.

The warning was issued after FDA lab analyses confirmed that sitbutramine, a controlled substance withdrawn from the market, was an active ingredient in Mix Fruit Slimming, Trim-Fast Slimming Softgel, Lingzhi Cleansed Slim Tea, Sliming (sic) Diet By Pretty White, Lipo 8 Burn Slim, and 24 Ince. More FDA Warns of Tainted Weight Loss Supplements

DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

DePuy Orthopaedics Inc. has been ordered to pay $4 million to settle allegations by the Oregon Department of Justice (ODOJ) that the medical device maker knowingly marketed faulty ASR XL metal-on-metal (MoM) hips.

The ASR XL all-metal hip device was intended to last 15 years, but studies showed the devices failed much sooner than expected. Data collected from the National Joint Registry of England in 2010 revealed that one in every eight patients (12 percent to 13 percent) had to undergo revision surgery within five years of receiving it.The hips have caused thousands of patients to experience pain, swelling, bone and muscle damage, and difficulty walking. More DePuy Must Pay Oregon $4 Million to Settle Allegations Related to its Marketing of ASR XL Hips

OTC Acne Products Linked to Serious Skin Reactions

The U.S. Food and Drug Administration (FDA) is warning the public that certain over-the-counter (OTC) topical acne products can cause rare but serious and even life-threatening allergic reactions.

In a safety communication, the agency said consumers should “stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.” Consumers are also advised to also stop using the product if they develop hives or itching. More OTC Acne Products Linked to Serious Skin Reactions

Key Ignition Problem Prompts GM to Issue 44th Vehicle Recall This Year

On Monday, General Motors (GM) announced that it would recall 3.16 million midsize and large cars to modify their ignition switches to avoid a replay of the problems that sparked a recall of 2.9 million small cars in February and March.

The faulty ignition switch has been linked to 13 deaths and 54 crashes. GM says it is aware of eight crashes and six injuries tied to the vehicles involved in the current recall, according to USAToday.com. More Key Ignition Problem Prompts GM to Issue 44th Vehicle Recall This Year

Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Managed care company Humana has sued Medtronic Inc., accusing the company of falsely representing its Infuse bone growth device as safe and effective in spinal fusion surgeries.

Humana filed the lawsuit in federal court in Tennessee on Friday. The complaint alleges that Medtronic paid for academic literature that fraudulently portrayed Infuse as safe and effective for off-label uses. According to court documents, Humana said that Medtronic engaged in a “sophisticated and deeply deceptive marketing strategy” designed to expand the market for Infuse, by urging and compensating spine surgeons to use the device by over-emphasizing its benefits and downplaying its serious risks, Reuters reported. More Human Sues Medtronic, Accuses the Company of Falsely Representing its Infuse Bone Growth Product

Study Links Excessive Cell Phone Use to Brain Tumors

People who use their cell phones with great frequency may be at an elevated risk of being diagnosed with a brain tumor, according to a new French study.

The study authors cautioned that it’s still not clear if there’s added risk for the majority of cell phone users, but say a link may exist between excessive cell phone use and brain tumors. They added, that since the devices and the way people use them is ever-changing, more research is needed going forward, Fox News reported. More Study Links Excessive Cell Phone Use to Brain Tumors