Gary D. McCallister & Associates

Darvon and Darvocet Linked to Heart Problems, Overdose

Gary McCallister — Mon, 07 Mar 2011 00:22:21 +0000

The prescription drugs Darvon and Darvocet have been pulled from the market after the active ingredient, propoxyphene, was linked to heart problems including heart arrhythmia, heart attacks, and sudden death. While both Darvocet and Darvon contain propoxyphene, Darvocet is a combination of propoxyphene and acetaminophen. According to the U.S. Drug Watchdog, a national consumer advocacy group, these drugs are some of the most prescribed drugs in U.S. history with over 22 million prescriptions issued since its introduction in 1957. Because these drugs have been on the market for so long, many patients with prescriptions for Darvon, Darvocet, or propoxyphene may not have heard of the recall and still have these drugs on their shelves. Despite the drugs popularity, the painkillers were pulled from the market in November, 2010 due to the Food and Drug Administrations (FDA) recommendation. The FDA stated that Darvon and Darvocet “puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.” Producers of generic drug forms containing propoxyphene have also been told to halt production. Additionally, the drug was associated with dosing problems according to the New York Times. Concerns about drug overdose caused the drug to be pulled in Europe as early as 2005. The FDA had previously given the drugs a black box warning about the risk of fatal overdose in 2009. The FDAs decision to not ban the drug was met with harsh criticism in 2009. Even a proper dosage of propoxyphene is still associated with heart risks. Given these drugs checkered history, it raises the question of why these drugs werent taken off the market sooner in the interest of public safety.

Radiation Treatment in Evanston, Illinois Hospital Puts Mother in Coma

Gary McCallister — Thu, 10 Feb 2011 00:20:22 +0000

An Illinois woman was left in a coma after receiving stereotactic radiosurgery (SRS). SRS is a highly complex form of intense radiation therapy that emits high, but concentrated doses of radiation to the brain to combat tiny tumors and other problems. The surgery was performed at Evanston hospital, which now, according to investigation, lacked the properly functioning equipment. Evanston hospital, along with other hospitals around the country, use linear accelerators modified to emit a smaller beam of radiation capable of performing the complicated surgery instead of a Gamma Knife machine. Some of the modifications apparently caused the device to malfunction. Other hospitals that used the malfunctioning devices reported instances of operator error in not adjusting the machine in order to properly reduce the amount of radiation emission. However, Varian is being accused of not installing the appropriate safety mechanisms in its product. The Food and Drug Administration (FDA) is responsible for monitoring the safety of the device, which does not actually use radioactive material in producing radiation. But some are saying that the FDA does not have the proper authority to investigate deeply enough into these incidents. Furthermore, there is no uniform system of data reporting that can shed light on how prevalent these errors are occurring. However, these are not small errors with small consequences. One Illinois woman is now incapacitated as a result of receiving a radiation dose 4 times stronger than it should have been during her SRS treatment. The 50 year old mother of 3 was receiving the surgery as a treatment for trigeminal neuralgia, a brain condition that causes facial pain. SRS surgery needs to be perfectly accurate in targeting the trigeminal nerve because of the large amount of radiation, unlike other forms of radiation treatment that are delivered in multiple, less potent doses. At first the woman had no symptoms of radiation overdose, but within 4 weeks quickly deteriorated to a vegetative state according to friends and family, and doctors say her likelihood of recovery is slim. Despite the tragedy of this incident, no investigation by any regulative body has been launched into why this radiation overdose occurred. Varian, the company that produced the modified linear accelerator, has also declined to respond to questions. Adjusting the linear accelerators to perform the SRS surgery required a technological complex system of data input into the hospital computer system that controlled patient treatment plans. However, instead of making sure there were systematic backstops to prevent this kind of error from occurring with their machine, Varian instead put only a warning decal on their device telling operators to be extra careful in adjusting the amount of radiation. Only after this accident did Varian develop software to prevent a similar glitch. However, there is still no way of knowing how many patients have received radiation overdoses from these devices, which could cause cancer or other harmful long-term effects.

IL AG Issues Warning on Baby Crib Bumpers

Gary McCallister — Tue, 04 Jan 2011 00:17:58 +0000

The Illinois Attorney General, Lisa Madigan, has just issued a warning for all baby crib bumper pads used in cribs, bassinets, and any other sleeping place for infants because of the risk of suffocation or strangulation. Bumper pads are typically found in cribs where they are wrapped around and tied to the crib slats. Many parents use them because they appear to prevent babies heads from getting stuck in their cribs; however, this is now known not to be the case. A number of deaths and injuries have been connected to bumper pads. The pads can cause suffocation if the baby rolls up against them, gets their head stuck between the pad and the crib, or their neck gets caught in the bumper ties. Babies lack the muscle strength and motor development to free themselves if caught or stuck. These bumpers have caused 14 known deaths since 2008 according to the National Center for Child and Death Review. The real number could be more since medical professionals and coroners arent required to report deaths caused by crib products to the government. Madigan issued a statement saying, Parents and caregivers should remove these bumpers to prevent tragedy. Attorney General Madigan has also urged the Juvenile Products Manufacturers Association (JPMA) to release the results of a study conducted on the dangers of crib bumpers immediately so safety standards can be adjusted accordingly. The group previously refused to release the study citing the need for internal review. Now the groups website says they are considering the studys release for publication. Manufacturers and sellers of baby bumper pads have been notified of the warning but no recalls have been issued thus far. Madigan hopes her campaign will notify parents in the absence of a recall. Hopefully in the meantime by raising awareness about the danger of these pads, parents and nurseries will remove them themselves.

Elderly Women More Likely to Receive Unnecessary Catheters

Gary McCallister — Tue, 09 Nov 2010 00:15:16 +0000

US researchers have found that more than any other demographic group, elderly women are more likely to receive catheters when doing so is unnecessary according to the November issue of the American Journal of Infection Control. The study focused on a Michigan hospital over 12 weeks at 532 instances of catheter insertions in emergency room patients. After the study was completed, the authors discovered that women 80 years old or older were almost three times more likely than patients under 50 and almost twice as likely as men to have a catheter inappropriately inserted. In about 40% of patients, there was no documentation from a physician to support the decision to insert a catheter. The main danger of inappropriate catheter placement is the high risk of hospital acquired infections, mainly urinary tract infections (UTIs). The more catheters are erroneously inserted in elderly women the higher the risk of contracting such an infection. These infections are almost 100% preventable by following established guidelines of care. In fact, these infections are so preventable that they are typically no longer reimbursed by Medicare and Medicaid. Despite the high rates of catheter-related UTIs and other infections, urinary catheter utilization is rarely systematically monitored by hospitals. If these statistics are not monitored, how can hospitals hope to do better? UTIs and other infections can be potentially deadly to the elderly. These alarming statistics show that physicians and nurses are consciously disregarding evidence-based guidelines on catheter insertion, resulting in the unnecessary exposure of elderly women and other patients to infection.

DePuy UPDATE: Company Failing to Live Up to its Promise to Cover Costs

Gary McCallister — Wed, 03 Nov 2010 00:13:29 +0000

In August, DePuy recalled almost 100,000 hip replacement devices after it was discovered that almost 12% of surgeries resulted in complications or required second revision surgeries within 5 years of initial implantation. Despite claims from the company that they would cover reasonable costs, many recipients of DePuy hip implants now claim the manufacturer is failing to live up to its promises and instead telling patients to seek compensation through private insurance plans or Medicare. The company issued a statement saying that it is “committed to assisting patients affected by the recall by paying for the cost of doctors visits, test and procedures associated with the recall,” but reports are cropping up that the company is telling injured patients to try to get their medical bills covered elsewhere and in some cases going so far as to blame the victim, as one Chicagoan recently claimed. Most people who have received the hip implants share similar stories. A device that was supposed to improve their quality of life considerably is now the source of excruciating pain, as the result of the implant failing to fuse to the bone. The revision surgery can costs anywhere from $50,000-$100,000 plus the costs of various diagnostic tests and follow-up visits. In some cases patients do not have enough bone density left for the surgery to be completed successfully. Revision surgery also takes around 2 months for recovery and leaves patients unable to walk resulting in loss of wages and mental anguish. In the end, taxpayers or insurance companies shouldnt have to foot the bill for costs associated with DePuys failure to ensure the quality of their products.

DePuy Hip Replacement Recall Issued

Gary McCallister — Wed, 27 Oct 2010 00:10:33 +0000

At the end of August, DePuy Orthopedics, Inc., an operating company of Johnson & Johnson, voluntarily recalled its ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. The Acetabular system was a traditional hip socket replacement, while the Hip Resurfacing System was a partial replacement system involving placing a metal cap on a patients femur. First becoming available in July of 2003, Surgeons preferred using DePuy ASR devices for younger patients because of their larger structure diameter, which enhanced stability. The Food and Drug Administration (FDA) had been receiving complaints about the devices for over two years and recently warned the company for using their hip replacement devices for non-FDA approved uses. Over 400 complaints were received in 2010 alone. DePuy included over 93,000 units in its recall, mostly due to loosening of the implant, bone fracture, or implant dislocation. Often patients reported needing revision surgery due to these problems, a painful and costly procedure. According to DePuys own statistics, 1 in 12 patients who received the resurfacing device and 1 in 13 patients who had a complete replacement required corrective surgery.

Not an Easy Fix

Many patients required revision surgery for a second hip implant five years after having the first hip replacement device implanted. Most surgeries are the result of debris caused from the wear and tear of the devices metal parts. As a result, some patients reported pain and swelling around the bone. Other patients allege toxic particles excreted from the device prevented it from properly fusing to their bones. Some were unable to receive a replacement device, leaving them unable to walk and bringing their lives to a standstill. Although DePuy estimates around 10,000 patients will need revision surgery due to these devices, the true number is still unknown. In 2009, DePuy claimed they were no longer planning to produce the implants due to poor sales. In March of 2010 DePuy warned doctors of low success rates with the implants. However, at that point DePuy had already been served with lawsuits alleging that there were defects in their hip implant products. DePuy has stated they will cover reasonable medical costs associated with the ASR devices including monitoring, doctor visits, and revision surgeries.

Evenflo Car Seats Recalled

Gary McCallister — Wed, 20 Oct 2010 00:08:38 +0000

Almost 14,000 Evenflo car seats have been voluntarily recalled by the company as well as the National Highway Traffic Safety Administration. The Maestro booster seats manufactured by the company were recalled due to the results front impact crash testing performed by Consumer Reports. In some cases a crack caused the seat to break and in others the harness loosened enough to hypothetically allow a child to slide forward during a crash occurring at 30 mph although no injuries have been reported. Recalled seats begin with model numbers 310 and were manufactured during November 2009 to April 2010. The model number can be found behind the shoulder strap. The company is not offering a refund but is issuing a free repair kit to fix the faulty reinforcement bracket to anyone who calls 1-800-233-5921 between 8 a.m. and 5 p.m. EST. Children under 40 pounds should not be placed in the seats before they are repaired. Evenflo had previously voluntarily recalled one million seats in 2008 for a separate problem related to crash testing. Overall, Evenflo has issued more recalls for its various products in the last two years than any other US Consumer Product Safety Commission (CPSC) rated manufacturer, totaling over 2 million products. Evenflo has said in statements that they prefer the phrase safety upgrades as opposed to voluntary recall, if thats any comfort to parents and children affected by the recall.

Choosing a Quality Nursing Home for Your Loved Ones

Gary McCallister — Mon, 02 Aug 2010 00:03:42 +0000

Picking a nursing home is a stressful and emotional process. Its important when deciding on a facility to pick one that is a safe and nurturing environment. Illinois has the second highest number of poorly ranked nursing homes in the country behind Indiana. Elder abuse and neglect is a rampant problem in nursing homes across the country. People in homes are susceptible to abuse physically, emotionally, and even financially. Furthermore negligent care can have serious health consequences for residents who are managing illnesses. The Centers for Medicare and Medicaid Services ranks nursing homes on a scale of one to five stars. Their data can be looked up at medicare.gov under the nursing home compare link. Additionally, call an ombudsman to find out about any specific complaints registered about that nursing home. (find local ombudsman here. These are both good resources to use when researching a facility, but personally investigating the nursing home is vital to making a final decision.

Visiting the Facility

When choosing a home, its important to be proactive! Make sure to visit the home separately at day and night to see the full range of care provided. When visiting prospective nursing homes, ask to meet with the executive director, lead physician, and head nurse. If they avoid speaking with you, that could be a bad sign. Another good idea is to attend a resident or family council meeting to learn more about the home and the cycle of care it provides. If possible, find homes that practice person-centered care. This allows residents to make their own schedules for sleeping, eating, and other activities, giving the resident more freedom. Its also a good idea to find out if they have consistent assignment, meaning that patients interact exclusively with the same staff on a daily basis. Having consistent relationships helps improve the residents quality of life.

Red Flags

High Staff Turnover

What is the percentage of staff turnover each year? Over 30% turnover may indicate a problem.

Odors

What does it smell like when you enter the home? A stench of urine could indicate low quality care. The smell of cleaning solution also may not mean the facility is clean but some other smell is being covered up.

Restraints

Look out for restraint devices on wheelchairs, beds, and/or chairs.

Food

Are residents allowed a choice for their meals? Are they allowed snacks in between meals if they get hungry? Are those who cant feed themselves being assisted?

Staff interaction with residents

Watch out for any rude or disrespectful behavior from staff members towards residents. This could be indicative of elder abuse. Any shouting by staff members is inappropriate and evidence of a high stress environment.

Resident behavior and appearance

Pay attention to the disposition of residents and whether or not they look depressed. Activities should be available for those who want to participate.

Privacy and Security

Access to different parts of the facility shouldnt be too freely granted or too restricted.

Organization

There should not be dirty linens or unstored linens in the hallways. Residents should always receive medications on schedule and staff should wait to make sure they are fully swallowed.

Elder Abuse

Abusive caregivers will often try to mask the signs of abuse by chalking them up to dementia or illness. Unexplained injuries, bruises, welts, scars, broken bones, sprains, dislocations, incorrect dosing of medication can be signs of physical abuse. Emotional abuse can be detected by observing threatening or belittling behavior by staff or behaviors such as rocking back and forth, sucking, or mumbling to oneself. Signs of neglect can be weight loss, malnutrition, dehydration, bed sores, or dirty bedding. Any combination of these signs is an indication to look elsewhere for the care of your loved ones.

Actos and Avandia Increase Risk of Bone Fractures

Gary McCallister — Mon, 02 Aug 2010 00:01:29 +0000

Actos and Avandia, diabetes drugs also known as TZDs have been definitively linked to an increased risk of broken bones according to a new study from the Journal of Clinical Endocrinology & Metabolism. This past summer an FDA panel of experts voted to put new warning labels on Avandia because of its link to heart problems. Post-menopausal women over 50 were found to be most susceptible to bone fractures, with 71% of those who suffered fractures found to be taking Avandia or Actos. Men also experienced fractures while taking a TZD combined with a loop diuretic often prescribed to diabetes sufferers.

Avandia – Should it Stay or Should it Go?

Gary McCallister — Thu, 15 Jul 2010 23:59:13 +0000

The FDA held a panel this week to decide on whether Avandia, a diabetes drug effective in lowering blood sugar levels, should be restricted or taken off the market entirely due to risks to heart health. The maker of Avandia, GlaxoSmithKlein, claims Avandia is safe and that evidence of the risks has been exaggerated pointing to its own RECORD study for support. However, many now say that the RECORD study was fundamentally flawed and would never have held water in the drug’s initial approval process. An FDA study indicates that seniors taking Avandia compared to seniors taking Actos (a comparable and competing drug) had significantly higher risks of heart attack, stroke, and fatality. 12 members of the panel voted to discontinue the distribution of Avandia, 10 voted that it should be distributed but its use curtailed with additional label warnings and possible sale restrictions, 7 voted for more label warnings alone, and 3 voted to continue sales with no changes. The FDA does not have to follow the recommendations of the panel and will reach a final decision in the near future.