Archive for November, 2006

Drug Stents May Raise Blood Clot Risk

Thursday, November 30th, 2006

Patients who are receiving stents—drug-coated heart devices—have four to five times an increased risk of developing blood clots, according to a new data analysis.

The analysis conducted by the Cleveland Clinic was of 14 studies involving 6,675 patients. The results are sure to cause concern over the safety of these small, wire-mesh devices used to hold open arteries that have been surgically cleared.

Blood clots, or thrombosis, may lead to severe injury such as heart attack or death.

“Our analysis found that there is a small, but real hazard of late stent thrombosis with drug-eluting stents more so than with bare-metal stents, likely in the setting of discontinuation of anti-clotting drugs,” said Cleveland Clinic official Dr. Deepak Bhatt.

However, Bhatt added that this analysis does not necessarily mean that drug stents should no longer be used since it has been proven that they are more effective than the bare metal kind.

The U.S. Food and Drug Administration’s panel of experts will meet next week to discuss the safety of drug-coated stents.

Family Of Man Who Attempted Suicide Sues Police

Thursday, November 30th, 2006

The mother of a man who attempted suicide while in jail filed a federal lawsuit against police, claiming their negligence led to his permanent disability.Dean Vargo, of Plum, was arrested two years ago for failure to appear in court for drug possession and related charges. While in jail, he attempted to hang himself.

When he was arrested, Vargo was found to be under the influence of heroin, which should have prompted police to place him under a suicide watch, according to the lawsuit.

Paramedics performed cardiopulmonary resuscitation after he tried to hang himself with a T-shirt but he has been a “human vegetable” since, the lawsuit claimed.

Drugstore Pays Suit Settlement

Thursday, November 30th, 2006

CVS Pharmacy will pay $4,000 to a Carlisle family as part of a lawsuit settlement stemming from an incorrect prescription.

Cumberland County Judge J. Wesley Oler signed a settlement order in favor of Daniel Madio II and Tina Madio, whose 4-year-old son, Benjamin, will receive $2,768.27 after legal costs.

The boy will have access to the money after he turns 18.

The suit, filed in 2004, said the pharmacy on South West Street in Carlisle dispensed a Zantac refill for the boy’s gastroesophageal reflux condition. When the parents got it home, they noticed the medication tasted different than a previous prescription had.

But they thought it was just flavored differently and gave the boy most of the medication before finally taking it back to the pharmacy, where a pharmacist determined the prescription was labeled incorrectly and it was actually Zyrtec, an allergy medication.

Ex-Guards, Nurse Charged In Florida Boot Camp Death

Thursday, November 30th, 2006

A teen’s death at a juvenile boot camp has led to a shake-up in Florida’s criminal justice system, the resignation of Florida’s top law enforcement officer, and now aggravated manslaughter charges for seven former guards and a nurse.In the past 11 months, news stations have repeatedly aired a surveillance video showing the guards beating and kicking 14-year-old Martin Lee Anderson during a 30-minute altercation at the Bay County sheriff’s camp in Panama City on Jan. 5. The nurse is seen doing nothing to stop the scene.

Guards said Anderson was uncooperative and had refused to participate during group exercises. The teen collapsed in the camp’s exercise yard and died at a hospital the next day.

The nurse, Kristin Anne Schmidt, was expected to have a bond hearing Wednesday. She and seven former guards were charged Tuesday.

“Today is a good day for me. I’m finally getting justice for my baby,” said Gina Jones, Anderson’s mother.

The seven guards have bonded out of jail on $25,000 bail. An arraignment was scheduled for mid-January and the defendants will be tried together. All face up to 30 years in prison if convicted of the first-degree felony.

Schmidt’s attorney, Jim Appleman, told The News Herald of Panama City that his client was not able to turn herself in until about 11 p.m. Tuesday because she was fulfilling obligations to a Hospice patient.

The death prompted the state to dismantle its military-style detention system for young offenders, sparked protests at the state Capitol and prompted the resignation of Florida Department of Law Enforcement chief Guy Tunnell, who started Bay County’s boot camp when he was sheriff there.

Gov. Jeb Bush signed a bill in May to replace Florida’s boot camps with programs that offer job training and counseling and prohibit physical discipline.

Dr. Vernard Adams, the medical examiner for Hillsborough County, ruled the guards’ hands blocked the boy’s mouth, and the “forced inhalation of ammonia fumes” caused his vocal cords to spasm.

The guards had said in an incident report that they used ammonia capsules five times to gain cooperation from the boy who was in custody for a probation violation for trespassing at a school.

The guards charged are Charles Helms Jr., 50, Henry Dickens, 50, Charles Enfinger, 33, Patrick Garrett, 30, Raymond Hauck, 48, Henry McFadden Jr., 33, and Joseph Walsh II, 35.

“To a degree, it is a relief to have the charge filed because that other shoe has finally dropped,” said attorney Waylon Graham, who represents Helms Jr. “This wasn’t a surprise to anybody. Now we can go forward.”

Jonathan Dingus, who represents McFadden, said he and his client were ready to begin their defense.

Garrett said through his lawyer, Bob Sombathy, that he was disappointed that charges were filed. “He’s relieved that the facts in his case will finally come out,” Sombathy said.

Bob Pell, an attorney who represents Walsh, said he learned of the decision to charge his client from The Associated Press.

“I didn’t anticipate it. I was hoping cooler heads would prevail,” he said.

An initial autopsy found Anderson died of natural complications of sickle cell trait, a usually benign blood disorder. But after an uproar and cries of a cover-up, a second autopsy was conducted by another medical examiner, and it concluded Anderson suffocated because of the actions of the guards.

Still pending is the family’s wrongful death lawsuit against the state Department of Juvenile Justice, which oversaw the boot camp system, the Bay County Sheriff’s Office and the seven guards. They are seeking more than $40 million in damages.

FDA Warning - Material Regarding Seroquel is “Misleading”

Wednesday, November 29th, 2006

The U.S. Food and Drug Administration (FDA) has issued a letter to AstraZeneca, the manufacturer of Seroquel (quetiapine fumarate) stating that a piece of promotional material for Seroquel tablets is false or misleading and requesting that AstraZeneca “immediately cease the dissemination of violative promotional materials for Seroquel.” According to the letter,

“This piece is false or misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia, and the bolded cataracts precaution … The promotional material raises significant public health and safety concerns through its minimization of the risks associated with Seroquel.”

Seroquel is an atypical antipsychotic medication that is FDA-approved for the treatment of acute manic episodes associated with bipolar disorder and for the treatment of schizophrenia. It is also sometimes prescribed off-label for headache and migraine prevention.

 

In 2003, following review of the data available regarding the use of atypical antipsychotic medications and diabetes adverse events, the FDA asked the manufacturers of these medications to include a warning in their patient information regarding the risk. AstraZeneca complied with that request. In question is information now being presented in promotional materials for Seroquel. AstraZeneca has until November 30, 2006 to comply with the conditions set forth in this warning letter.

Actonel Is Better Than Fosamax In Combating Boss Loss After Menopause

Wednesday, November 29th, 2006

Both Actonel and Fosamax prevent bone loss after menopause.  However, a study by leading osteoporosis experts say Actonel works faster than Fosamax.

Actonel (made by Procter & Gamble) and Fosamax (made by Merck) are both effective treatments for age-related osteoporosis. Age-related osteoporosis is a type of bone loss that is a particular problem for postmenopausal women.

Actonel and Fosamax are members of a class of drugs known as bisphosphonates, as is a newer drug, Boniva made by Roche.

Evidence has indicated that Actonel may work more quickly to prevent fractures, especially the more common hip and non-spine fractures that can greatly reduce a person’s quality of life.

However, how accurrate are these findings?

Nelson B. Watts, M.D., Director of the University of Cincinnati Bone Health and Osteoporosis Center, joined a team of internationally renowned experts in an effort to find out.

In the study, insurance records for 12,215 postmenopausal women who took Actonel and 21,615 women who took Fosamax for the first time were analyzed.  All of the women in the study were 65 and older.

The findings suggested that after a year of treatment, the women taking Actonel had 43% fewer hip fractures and 18% fewer non-spine fractures than the women taking Fosamax.

“This adds to the suggestion from clinical trials that Actonel works faster than Fosamax,” Watts tells WebMD. “We found a significantly lower rate of fracture at hip and non-vertebral sites for patients given Actonel vs. Fosamax at both six and 12 months.”

“I am not saying one drug is better than the other — only that Actonel works faster,” Watts says.

The study — sponsored by Procter & Gamble and Sanofi — appears in the November 2006 online issue of the journal Osteoporosis International.

Watts is eager to mention that the study is not a clinical trial and therefore cannot be taken as conclusive proof regarding the two drugs.

On the other hand, the study impresses Holly Thacker, M.D., Director of the Women’s Health Center at The Cleveland Clinic.

Thacker, who was not involved in the study, points out that Watts and colleagues looked at the kind of women doctors see in real life. Moreover, they evaluated the endpoint that really matters to women suffering from osteoporosis — actual bone fractures.

“I tend to prescribe Actonel more often than Fosamax, so this study is reassuring,” Thacker says.

“We now have some excellent drugs for bone loss. In the bisphosphonate family, I rank Actonel No. 1, with Fosamax a close second,” she says. “I rank Boniva a distant third, because it has not yet been shown to reduce hip fracture.”

Describing both drugs as being equal, Watts and Thacker would prescribe Actonel over Fosamax.

But both of these top doctors bring up a valid point - not all women are equal. Some women may have a higher tolerance to one drug over the other. Or their insurance may pay more for one drug than the other.

In either scenario, women will benefit the most from the drug that works best for them.

Watts adds that bone-loss drugs should be taken for several years. But most patients stop taking them after six or seven months — greatly reducing their potential benefit.

“When we start someone on osteoporosisosteoporosis treatment, we hope they will continue taking it for years,” Watts says.

“But bone loss is a silent disease — like high blood pressurehigh blood pressure or high cholesterolhigh cholesterol. Until something happens, the disease doesn’t make them feel bad, and the drug doesn’t make them feel better. That is sometimes hard for people to accept,” he says.

Thacker also stresses the importance of long-term treatment. Unlike Watts, who usually begins drug treatment only when a woman has frank osteoporosis, Thacker begins as soon as she detects the slightest bone loss in the patient.

“Once you’re starting to lose bone mass, you need to be on treatment,” Thacker says.

“First, we make sure a woman is getting enough calcium and vitamin D,” Thacker says. “But if she is, and she’s still losing bone mass, we start treatment. It is a long-term commitment. The chances are, you will be on it for a long time.”

Toy-Related Deaths And Catastrophic Toy-Related Injuries

Wednesday, November 29th, 2006

CPSC has reports of 16 toy-related deaths involving children younger than 15 years old that occurred in 2004. In that same year, an estimated 161,100 children under 15 went to U.S. hospital emergency rooms with injuries relating to toys.

Toy-Related Deaths

Victims of the 16 fatal incidents involving toys ranged in age from 3 months to 9 years old. Ten of the victims were males. Their deaths occurred in the following ways: Choking/asphyxia, drowning, entanglement, asphyxia/smothering, or involvement with a motor vehicle.

  • Choking/Asphyxia: Seven children died when they choked on or were asphyxiated by a toy.
  • Motor Vehicle Involvement: Four children died while on riding toys. These incidents occurred when the child was either struck by or ran into a motor vehicle.
  • Drowning: Two children drowned in incidents involving tricycles.
  • Entanglement: Two children died from becoming entangled in toys.
  • Asphyxia/Smothering: There was one fatality involving an infant who smothered at a childcare center when older children piled stuffed animals into his crib.

Toy-Related Injuries

In 2004, an estimated 210,300 people of all ages were treated for toy-related injuries in U.S. hospital emergency rooms. Males were involved in 58% of the toy-related injury incidents. Most victims (97%) were treated and released from the hospital. Forty-six percent of the injuries (96,800) occurred to the head and face area, which includes the head, face, eyeball, mouth, and ear. Arms, from shoulder to finger, accounted for 25% of the injuries (52,000), while the leg and foot area accounted for 18% (38,200). The individual body parts having the most injuries overall were faces (43,700), heads (24,800), and mouths (14,700). Lacerations, contusions, and abrasions were involved in over half of the total injuries (51%). In 2004, riding toys (including unpowered scooters) continued to be associated with more injuries (71,100 or 34%) than any other category of toy. Of those, 51,400 of riding toy injuries were related to unpowered scooters.

Family Of Man who Attempted Suicide Sues Police

Wednesday, November 29th, 2006

The mother of a man who attempted suicide while in jail filed a federal lawsuit against police, claiming their negligence led to his permanent disability.Dean Vargo, of Plum, was arrested two years ago for failure to appear in court for drug possession and related charges. While in jail, he attempted to hang himself.

When he was arrested, Vargo was found to be under the influence of heroin, which should have prompted police to place him under a suicide watch, according to the lawsuit.

Paramedics performed cardiopulmonary resuscitation after he tried to hang himself with a T-shirt but he has been a “human vegetable” since, the lawsuit claimed.

Allegheny County police investigated Plum’s handling and found no wrongdoing, said Mike Thomas, borough manager.

The suit seeks unspecified monetary damages for negligence and breach of duty.

Consumer Group Issues ‘Troubles In Toyland’ List

Tuesday, November 28th, 2006

While shoppers will be eagerly snapping up toys for their children this holiday season, one consumer advocacy group is urging vigilance before parents spend a single dollar.

Issuing their 21st annual “Trouble in Toyland” report Tuesday, the Washington-based U.S. Public Interest Research Group warned that there are many toys out there that pose significant safety hazards to children.

“While we can report substantial progress after more than two decades of advocacy on behalf of America’s littlest consumers, U.S. PIRG’s researchers still found trouble in toyland,” U.S. PIRG Research Director Alison Cassady, the author of the report, said.

Nearly 73,000 children under the age of five visited the emergency room for toy-related injuries in 2005, according to the Consumer Product Safety Commission, and 20 children died from toy-related injuries last year.

PIRG, which visited both toy stores and retailers to find toys carrying safety risks, focused on four specific toy dangers - choking, strangulation, dangerously loud toys and those that contain toxic chemicals.

Choking on small parts, balls or balloons remains the biggest threat posed to children, according to PIRG, particularly from such toys as Wal-Mart’s Kid Connection Mini Activity Cube.

Hasbro’s Lincoln Logs Frontier Firehouse was another toy singled out by PIRG that could pose a choking hazard, while Little Tikes’ Carry Along Musical Keyboard with Teaching Lights was considered a dangerously loud toy for children by PIRG.

PIRG also warned of a number of toys that contain magnets, which could cause internal harm if swallowed by a child.

“Swallowing a magnet is not like swallowing a penny,” said Cassady. “Powerful magnets can wreak havoc inside the body.”

The consumer watchdog also said it discovered a number of toys, including cosmetics and jewelry, that contain harmful chemicals, including high concentrations of lead that can cause lead poisoning.

While most toys were produced by private firms or imported into the U.S. from foreign countries, a number of the toys cited by PIRG were produced by large U.S. companies like Mattel.

Polly Pocket Toys Recalled After Children Swallow Magnets

Tuesday, November 28th, 2006

More than four million Polly Pocket toys worldwide have been recalled this month after three young children suffered serious injuries from swallowing the small magnets that fell off the play sets, announced the Consumer Product Safety Commission.

The commission claimed they had gotten 170 reports that the tiny magnets were falling off the defective Polly Pocket dolls and accessories. The three kids who were injured and hospitalized swallowed more than a single magnet and suffered from intestinal perforation, requiring surgical treatment.

Currently, the toy manufacturer Mattel, Inc. is in the process of making “appropriate revisions to the U.S. toy standard to prevent such issues in the future,” according to the vice president of communications, Sara Rosales.

Magnet Dangers

The Polly Pocket set consists of dolls that have 1/8 inch round magnets embedded in their hands and feet. The accessories included in the play set such as hair pieces and plastic clothing also contain small magnets, which can easily fall out and be inhaled or swallowed by children.

In the event that more than one tiny magnet is inhaled, they may attach in the stomach causing potentially fatal injuries such as intestinal perforation, blockage, or infection.

Almost two and a half million Polly Pocket sets manufactured before April 2005 and sold in the U.S. between May 2003 and September 2006 are being recalled. Another two million toys sold worldwide are also affected by the recall.

In March, another magnet-containing toy, Mega Brands, Inc.’s Magnetix building sets was recalled when one child died and several others were seriously injured after swallowing the small magnets.

Last year in the United States, there were 20 toy deaths and 152,400 injuries involving kids younger than 15.

Consumer Warnings

As Christmas approaches, consumers are urged to avoid buying young children any toy sets that contain small magnets and other small parts or sharp edges. All labels should also be checked for age appropriateness.

All Polly Pocket toy sets purchased between May 2003 and September 2006 should be taken away from children and returned to the manufacturer.