FDA Proposed Dietary Supplement Rules Called Too Lax
The U.S. Food and Drug Administration’s (FDA) proposed dietary supplement rules are being called too lax. The proposal is meant to strengthen the agency’s power to regulate dietary supplements, but some feel it falls short.
Supplement makers manufacturing vitamins, minerals, and botanical extracts, are angry about the propsed new rules, but others disagree, said The LA Times, pointing to a New England Journal of Medicine editorial that says the FDA proposed powers are simply not strong enough. Continue reading
Foot-Long Subs Recalled For Possible Listeria Risk
Foot-long subs are being recalled for potential food poisoning risks, the U.S. Food and Drug Administration (FDA) just announced. M.E. Thompson, Inc., Jacksonville, Florida, has recalled its Anytime Deli Turkey & Ham Sub Sandwich over concerns the sandwiches might be contaminated with the dangerous, sometimes deadly, Listeria monocytogenes pathogen.
The recalled Anytime Deli Turkey & Ham Sub Sandwich, which bear UPC 0543200194 and an expiration date of January 19th and January 22nd, were distributed on January 2nd and 3rd to convenience stores in Florida and South Georgia under the label Anytime Deli Turkey & Ham Footlong. Continue reading
Costa Concordia Owner Offers Compensation to Uninjured Cruise Ship Passengers
The operator of the doomed Costa Concordia cruise ship has offered most passengers – those who were not injured in the disaster – $14,460 each for their lost baggage and psychological distress. However, one Italian consumer group has deemed the Costa Concordia offer insufficient, and is urging passengers to reject it.
The Costa Concordia struck a rock off the coast of the Italian island of Giglio on Friday, January 13. The collision tore a 160-foot hole in the hull of the ship, and caused the vessel to capsize. The cruise ship, which is owned by the Italian company Costa Crociera SpA, a subsidiary of Miami-based Carnival Corp., was carrying 4,200 passengers and crew when the accident occurred. At least 16 people died in the accident, and as many as 22 passengers and crew are still unaccounted for. Continue reading
Deaths Reported After Doctors Ignored Kenalog Steroid Injection Warning
Doctors have largely ignored a warning issued by the makers of the Kenalog steroid injection, commonly used in an epidural injection during labor, despite that warning indicating use of it in certain indications could cause serious injury, permanent disability or death.
It was seven months ago when Bristol-Myers Squibb issued a public safety alert and changed the label of the Kenalog injection to indicate that use of it in epidurals has been linked with “serious medical events, including death” and that use of it as an epidural injection was “not recommended.” The company will not go so far as to say Kenalog was responsible for those deaths or injuries and the Food and Drug Administration failed to issue its own alert, as it usually does, when Bristol-Myers Squibb changed the labels on Kenalog. Continue reading
68 Sickened In Salmonella Outbreak Linked To Unnamed Mexican Restaurant
To date, 68 people have been sickened in a Salmonella Enteritidis outbreak that has been linked to an unnamed Mexican restaurant.
The restaurant is a quick-service Mexican restaurant chain, said Nation’s Restaurant News and the illnesses spanned 10 states in an outbreak federal officials say is over. Continue reading
Former Owner Of French Breast Implant Company Arrested
The former owner of a now-defunct French breast implant company has been arrested amid a worldwide cancer scare scandal involving tens of thousands of women who received defective silicone breast implants.
We recently wrote that Jean-Claude Mas, the 72-year-old founder of Poly Implant Prothese (PIP), was is being sought by Interpol on an unrelated drunk driving charge. At that time, Mas was potentially facing prison time in Costa Rica on the charge, but fled the country before he could be brought to trial. Continue reading
Costa Concordia Operator Knew Ship Was in Trouble Moments After Collission
A new report says the operator of the Costa Concordia cruise ship, Costa Crociere, was made aware that the doomed vessel was in trouble minutes after it struck a rock and began taking on water. According to a report from The Wall Street Journal, the revelation is also raising more questions about why the evacuation alarm on Costa Concordia was not sounded for more than an hour after the accident.
On Friday, January 13, the Costa Concordia struck a rock off the coast of the Italian island of Giglio that tore a 160-foot hole in its hull, and caused the vessel to capsize. The cruise ship, which is owned by the Italian company Costa Crociera SpA, a subsidiary of Miami based Carnival Corp., was carrying 4,200 passengers and crew when the accident occurred. At least 16 people died in the accident, and as many as 22 passengers and crew are still unaccounted for. Captain Francesco Schettino was placed under house arrest in the aftermath of the Concordia disaster, and is accused of causing the wreck and abandoning the ship. He allegedly took a detour from the planned route to navigate closer to Giglio. Continue reading
FDA Sets Social Media Rules For Pharmaceutical Companies
The U.S. Food and Drug Administration (FDA) has set social media rules for drug companies to manage how they interact with consumers when using social media.
Industry says it needs significantly more direction from the agency, said The American Medical Association (AMA). The agency’s draft guidance says all unsolicited information requests be handled in a nonpublic format. The AMA noted that requests include doctor requests for details on the off-label uses of certain medications. Continue reading
Novartis to Settle Drug Sales Rep Overtime Claims for $99 Million
Novartis Pharmaceuticals Corp. is set to pay a whopping $99 million to settle charges it illegally denied overtime pay to its drug sales reps. According to a report from Bloomberg News, the Novartis overtime pay settlement covers more than 7,000 current and former sales representatives.
“We believe this settlement is in the best interest of our employees and the company,” Andre Wyss, president of Novartis Pharmaceuticals, a unit of Novartis AG., said in a statement. “We have been litigating this case for nearly six years and the company has determined that it is time to resolve these wage and hours claims.” Continue reading
New York Teens Afflicted With Tourette’s-Like Disorder
Several high school girls and, now, one boy in New York State are exhibiting Tourette’s-like disorder symptoms. The phenomena has caught national attention and the attention of the National Institutes of Health (NIH).
To date, 17 students are suffering from the syndrome, said WNYT, with 15—including one boy—from Le Roy High School alone, said WGRZ. The NIH has offered a second opinion to the diagnosis provided by Dr. Mechtler, who has seen nine girls and one boy who exhibit the troubling symptoms, said WGRZ. Dr. Mechtler diagnosed the teens with Conversion Disorder, which, as a group, is known as mass psychogenic illness. Continue reading
