Posts Tagged ‘Dosing Errors’

Accidental Overdose Dextroamphetamine/Amphetamine 20mg Tablets

Friday, September 4th, 2009

Barr Laboratories, Inc., distributor for  Dextroamphetamine/Amphetamine 20mg Tablet bottles Lot number 311756, has announced a recall of the company’s  Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 20mg Tablets  that were distributed beginning June of 2009 for a period of 5 days. It is the potency of the super-therapeutic dose that has caused the alarm. The potency exceeds the approved dosage.

Side Effects from the Overdose Tablets include:

  • Tardive Dysnkensia
  • Tachycardia and heart palpitations
  • High blood pressure
  • Tremors
  • Dizziness
  • Distorted vision
  • Euphoria
  • Mania
  • Anxiety
  • Nausea
  • Irregular Bowel Movements
  • Dry Mouth
  • Lack of appetite

Consumers, pharmacists and medical providers can identify the tablet by its oval shape, peach color and written text on one side indicating b/973 and 2/0 on the other side. People with these tablets are advised to return them to the pharmacy in which they purchased the prescription.

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Kaletra Warning: Side Effect Data Inaccurate

Thursday, April 16th, 2009

People with heart disease, ischemic heart disease or cardiomyopathies should proceed with caution when using Kaletra. In fact, physicians may advise to discontinue the use of Kaletra and select an alternative for people in this category. It is also important to note that there has not been an evaluation of the interaction of Kaletra with certain other drugs such as calcium channel blockers, beta-adrenergic blockers, digoxin and atazanavi.

The FDA issued a warning about both the tablets and oral solution after cases of second and third degree atrioventricular blocks were reported. An atrioventricular block causes an impairment of the atria and ventricles of the heart. Second degree atrioventricular blocks have been linked to sudden death. Third degree atrioventricular blocks have been associated with heart attack and stroke. It has already been determined that Kaletra may cause serious injury when used by people taking any of the following drugs: ergotamine tartrate ( Cafergot®, Migergot, Ergomar, Ergostat, Medihaler Ergotamine, Wigraine, Wigrettes), dihydroergotamine mesylate (D.H.E. 45®, Embolex, Migranal®, ergonovine, ergonovine and methylergonovine (Ergotrate, Methergine), ergotamine and methylergonovine, Ergotrate Maleate, methylergonovine maleate (Methergine), triazolam (Halcion®), midazolam hydrochloride oral syrup, pimozide (Orap®), the cholesterol lowering medicines lovastatin (Mevacor®) or simvastatin (Zocor®).

Despite the concerns surrounding the limited evaluations about interactions with other drugs, Kaletra remains on the market today. People taking Kaletra who experience changes in their heart rate should seek out immediate medical attention. People that may have already suffered from serious side effects from Kaletra may also seek out the advice of a product liability attorney. Product liability attorneys understand personal injury cases and may be able to assist you in securing recovery from harm that you have sustained.

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Preventing Dosing Errors with Alteplase (March 2009)

Friday, March 13th, 2009

Video originally created by FDA -- posted by Lawsuit.com on March 10, 2009

In a recent report, the Institute for Safe Medication Practices warned about the possibility of prescribing and administering the wrong dose of alteplase when the indication for the drug is not specified.

ISMP described a case of a patient in an interventional radiology department who suffered respiratory arrest from a pulmonary embolism. The physician in charge of the radiology procedure called a code and requested Activase 100 mg IV. The pharmacist who responded to the code called the IV admixture staff and asked for tPA, or tissue plasminogen activator, a synonym for alteplase.

Because the call came from the radiology department, and because the prescribed dose and the intended use were not communicated, the pharmacy staff did not realize that the drug was intended to treat a pulmonary embolus. Instead, they assumed that the alteplase was intended to restore catheter function, so instead of the 100 mg dose that had been prescribed, they dispensed 2 mg of alteplase.

The physician running the code assumed the syringe he received contained the correct dose and administered it, which gave the patient a 50-fold underdose. The patient died, although it’s not clear what impact, if any, the medication error had on his death.

In analyzing the problem, ISMP points out that alteplase is used for a number of indications at a number of different dosages This makes it all the more important for persons who prescribe, dispense and administer alteplase to understand why it is being used in each case and to match the indication with the dose.

In non-urgent cases, ISMP recommends considering using disease-specific protocols and order forms. In an emergency, if you cannot use a disease specific order set, specify the purpose of the drug with the order, as well as the dose, the route of administration, and directions. ISMP says that pharmacists should not dispense the medication without this information.

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Ortho Evra Recall Sets the Stage for Lawsuits

Wednesday, February 25th, 2009

As Ed Jazlowiecki, Attorney at Law of Bristol Connecticut explains, “All oral contraceptives may cause injury, but Ortho Evra injuries are on the rise.” The FDA cited that Ortho Evra patch had placed thousands of potential women at risk for questionable levels of estrogen. Ortho Evra was the first oral contraceptive to deliver estrogen through a patch. Ortho Evra is manufactured by Ortho-McNeil.

At the Core of Concern

The stem of Ortho Erva’s increased risk for blood clots, stroke, heart attack and death lies in the disposition of the product. As Doug Monsour, Attorney at Law of Longview, Texas explains, “The dangers associated with Ortho Erva are under-reported. For example, smokers are particularly at risk. The overdose of estrogen and increased risk of blood clots coupled with cigarette smoking further increases the risk for deep vein thrombosis, pulmonary embolism, stroke heart attack and mortality.” The patch is designed to deliver hormones when applied to the skin. However, every woman has unique limitations when it comes to hormone exposure. Some contend that the healthcare system is ill equipped to monitor intake levels particularly in light of the fact that women taking Ortho Erva may be exposed to 60% more estrogen when compared to other oral contraceptives. Since 2002, the FDA had gathered numerous reports of women dying due to the product.

Ortho Erva Warning Signs
• Chest pain and tightness
• Difficulty breathing
• Calf pain
• Excessive headache
• Vomiting
• Dizziness and fainting
• Weakened speech capacity
• Vision impairment
• Breast lumps
• Stomach pain
• Insomnia
• Lack of energy
• Mood swings
• Jaundice
• Fever
• Appetite loss
• Darkened urine
• Bowel discoloration

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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.

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