Posts Tagged ‘Cancer’

Radiation Overdoses from CT Scans (December 2009)

Monday, December 21st, 2009

Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009

FDA is investigating a situation in which more than 200 patients undergoing CT brain perfusion scans at a single hospital received overdoses of radiation. In some cases the radiation doses were high enough to produce erythema and hair loss.

While these events involved one type of procedure at one facility, FDA is concerned that they could reflect more widespread problems with CT quality assurance programs. If patient doses from CT procedures were higher than the expected level but not high enough to produce obvious signs of radiation injury, the problem could go undetected and unreported. This could put patients at increased risk for long-term radiation effects, including certain types of cancer.

To help prevent overexposures, FDA is encouraging facilities that perform CT procedures to be aware of the dose indices displayed on the control panel. These indices include the volume CT dose index, expressed “milligray” (mGy), and the dose-length product, expressed in “milligray-centimeter” (mGy-cm). Before a patient is scanned, the operator should make sure that the values displayed for these indices correspond reasonably to those normally associated with the procedure being performed. These indices should be checked again after the patient is scanned.

FDA is working to obtain more information on reports of CT overdoses and encourage healthcare professionals to report these when they occur.

VN:F [1.5.6_840]
Rating: 0.0/10 (0 votes cast)
VN:F [1.5.6_840]
Rating: 0 (from 0 votes)

Possible Cancer Risk with Lantus (Sept. 2009)

Monday, September 14th, 2009

Video originally created by FDA -- posted by Lawsuit.com on September 3, 2009

FDA is investigating the possibility that Lantus (insulin glargine) may be associated with an increased risk of cancer. Three of four observational studies published recently in the journal Diabetologia suggested an increased cancer risk associated with Lantus. All of the studies had drawbacks or inconsistencies that preclude drawing any firm conclusions about whether the drug is actually associated with an increased risk of cancer.

FDA is reviewing many sources of safety data for Lantus, including these four newly published studies, to better understand whether this drug poses a cancer risk. The agency is also deciding whether any additional safety studies will be needed. FDA will keep practitioners and patients informed as new information becomes available.

In the meantime, FDA is cautioning patients not to stop taking their insulin without consulting a physician, since uncontrolled blood sugar levels can have serious immediate and long-term effects.

VN:F [1.5.6_840]
Rating: 0.0/10 (0 votes cast)
VN:F [1.5.6_840]
Rating: 0 (from 0 votes)

Possible Association between TNF Blockers and Cancer Aug. 08

Friday, February 20th, 2009

Video originally created by FDA -- posted by Lawsuit.com on August 12, 2008

FDA has informed healthcare professionals that it is investigating a possible association between drugs that block tumor necrosis factor (TNF) and the development of lymphoma and other cancers in children and young adults.

This is part of FDA’s commitment to inform healthcare professionals and the public about its ongoing drug safety reviews. Because this information is preliminary and there is scientific uncertainty, FDA is not taking regulatory action at this point, nor advising healthcare professionals to stop using the drugs.

The TNF blockers in question, Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab) and Cimzia (certolizumab pegol), are used to treat juvenile idiopathic arthritis, Crohn’s disease, and other inflammatory conditions. The labeling for these drugs already warns about a possible risk of cancer.

Over the past ten years, FDA has received about 30 reports of cancer in patients who were treated with TNF blockers when they were under 18 years old. These patients also took other immunosuppressive agents, such as methotrexate and azathioprine. Although these reports are cause for concern, in and of themselves they do not establish that TNF blockers increase the risk of cancer above background levels.

FDA is investigating all the available evidence about a possible link between TNF blockers and cancer, and is consulting with experts in this area to determine whether there are children with juvenile idiopathic arthritis and Crohn’s disease who may be at special risk of developing cancer if they take the drugs. This evaluation will take about six months, after which FDA will let health professionals and the public know about its conclusions.

In the meantime, health care professionals, parents and caregivers should be aware of the possible cancer risk in deciding the best way to treat these patients. FDA also encourages both healthcare professionals and patients to report side effects from the use of Remicade, Enbrel, Humira, and Cimzia, to the FDA’s MedWatch adverse event reporting program.

Again, this is preliminary information and it is part of FDA’s effort to keep the public informed about its ongoing drug safety reviews.

VN:F [1.5.6_840]
Rating: 0.0/10 (0 votes cast)
VN:F [1.5.6_840]
Rating: 0 (from 0 votes)

Personal Injury: Med Mal & Nursing Home (3 out 3)

Friday, February 13th, 2009

Medical Malpractice Legal Responsibility:

Medical malpractice
state laws have been rewritten over the years which have led to restricted rights for injured consumers due to medical negligence. Severity in harm and supporting documentation are crucial elements to establish validity in claims. As Manuel L. Dobrinsky,Attorney at Law, of Miami Florida, adds, “Doctors today have many more patients to manage than they had in the past. Thus, the risk of a medical error is more likely than years ago. For this reason, it is important for consumers to take a vested interest in their healthcare by being inquisitive about their diagnosis, medications, treatment, and follow up. In doing so, patients can reduce the risk of potential life threatening illness that may otherwise result in a failure to diagnose or misdiagnose an illness. “
Connected Topics:Medical Malpractice

Nursing Home Abuse Accountability:

Nursing home liability refers to emotional, physical or neglectful acts against an elder by a nursing home employee(s). This may include: malnutrition, dehydration, bed sores, wandering off premises, falls, sexual assault, battery, and wrongful death. Skilled nursing and intermediate care facilities must meet criteria set by Medicare and Medicaid should they serve Medicare or Medicaid recipients. Other facilities that wish to accept Medicare patients must meet standards set by the Federal Medicare Health Insurance Program for the Aged. There are also nursing homes that do not accept Medicare patients which allow them to not fall under federal guidelines. State requirements vary among the states. In fact, certain attorneys are creating movements through state
legislature to improve nursing home abuse accountability. As John J. Perconti, Attorney at Law, Chicago, Illinois, explains, “Nursing home abuse has become more common in recent years. Yet, the laws do not reflect upon the needs of today. For example, nursing homes are not required to carry liability insurance. All nursing home residents and their families need to be informed that the nursing home facility does not have insurance. If there is no financial accountability for negligence, these residents will continue to be neglected and abused.  The rights of abused victims are restricted under the current system.” Currently, Illinois is in the process of passing a bill that would require liability insurance in nursing homes.
Connected Topics: Nursing Home Abuse

Premise Liability:

Property damage or bodily harm that occurs on a homeowner’s property maybe the responsibility of the homeowner where the
damage took place. Homeowner’s insurance policies are designed to provide compensation for damages associated with accidents, negligence, and other forms of harm. A government agency may be liable in some instances whereby the accident occurs on the property of the government. An example of this would be slip and fall that occur because of cracks in sidewalks, faulty curbs, potholes, defective crosswalks, flawed stairs on buses and the like.

Some of the more common injuries that result in premise liability include:dog bites, slip and falls, or any type of property that is termed an attractive nuisance liability which is an item that can harm children regardless of reasonable precautions taken to prevent injury. As Arnold Hernandez, Attorney at Law, of San Diego County, CA explains, “Premise liability is founded on the idea that we all owe a duty of care to our fellow human beings to insure that there are no hidden risks of personal injury on our property and that we have exercised reasonable care in insuring we have removed foreseeable risks. The duty of care is much higher when it comes to children that may come onto our property and we must anticipate how children will behave, including: children’s conduct that to an adult would seem irrational.”
Connected Topics: Dog Bites, Slip and Falls.

Terms for Liability:

Timeliness is important when it comes to liability. Every state has specific rules relating to the number of days that you are permitted to file a claim. It is important to seek the advice of an attorney as soon as you can after injury to provide substantial time necessary to uncover the circumstances surrounding the injury and determine validity for a claim. Once a claim is filed, there will be a select number of days to file a lawsuit. It is important to note that the date of harm may be considered the date of discovery which can sometime occur years after the actual injury. In some cases, both the injured party and the party being held liable are found negligent. This is called comparative negligence. In other cases, negligence may be strictly due to the injured party. Depending
upon the circumstances, personal injury attorneys may refuse to take such cases.

VN:F [1.5.6_840]
Rating: 0.0/10 (0 votes cast)
VN:F [1.5.6_840]
Rating: 0 (from 0 votes)

Warning Added to Regranex Label (Aug. 2008)

Friday, December 5th, 2008

Video originally created by FDA -- posted by Lawsuit.com on August 12, 2008

A boxed warning alerting healthcare professionals to an increased risk of cancer death has been added to the labeling for Regranex (becaplermin), a topical medication used to treat certain diabetic foot and leg ulcers.Based on a review of an earlier epidemiologic study, FDA has concluded that patients who use three or more tubes of Regranex experience a five-fold increase in the risk of cancer death compared to patients who do not use the drug. The duration of the study was not long enough to establish whether there is also an increased risk of new cancers.In March 2008, FDA announced that it had received the epidemiologic study, described what the overall study findings were, and promised to analyze the study and communicate its findings to the healthcare community. The new boxed warning in the labeling is the result of that analysis.Foot ulcers are a serious problem among diabetics, and yet there are few treatment options. FDA says that Regranex can be effective when it is used along with good ulcer care practices, such as controlling infection, removing dead tissue and relieving pressure. However, the boxed warning says that Regranex should only be used when the benefits are expected to outweigh the risks, and that it should be used with caution in patients with known malignancies.

VN:F [1.5.6_840]
Rating: 0.0/10 (0 votes cast)
VN:F [1.5.6_840]
Rating: 0 (from 0 votes)