Source | FDA Patient Safety News

The U.S. Food & Drug Administration has released a video regarding: “Preventing Patient Deaths from Fentanyl Patches”

The information contained in the video is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

“Preventing Patient Deaths from Fentanyl Patches” — MOVIE LINKS

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A recent report from the Institute for Safe Medication Practices warns about the dangers of misprescribing fentanyl transdermal patches, such as Duragesic. ISMP reminds practitioners that these patches are intended only for patients who are opioid-tolerant, and should not be used for acute pain.

ISMP also pointed out other prescribing errors. In some cases, deaths occurred in patients who were prescribed multiple fentanyl patches, resulting in overdose. In other cases the fentanyl was prescribed in addition to other pain medications, such as oxycodone, or it was prescribed for patients with pre-existing respiratory compromise. ISMP points out that sometimes pharmacists have dispensed these prescriptions without questioning them, and nurses have applied the patches without recognizing the prescribing error.

Here are some of ISMP’s recommendations to help avoid these tragic and preventable errors:

• Prescribe fentanyl patches only for patients who are opioid tolerant, and who have chronic pain that is not well-controlled with shorter-acting analgesics. These patches should not be used for postoperative pain, or for pain that’s short-term or intermittent. Pharmacists should ensure that the patient is opioid-tolerant and suffering from chronic pain before dispensing the drug, and should question the prescriber if this is not the case.
• Set dosing limits. For example, pharmacy computer systems could be set to flash an alert if more than 25 mcg per hour has been prescribed as a first-time dose. Also, in evaluating whether the dose is appropriate, take into account other opiates or analgesics that may have been prescribed.
• Educate practitioners and patients to know the signs of overdose, which include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting.
• Prescribing errors are not the only cause of deaths and injuries from fentanyl patches. They also occur when patients mis-use the patches. Sometimes patients and family members do not understand that heat can increase absorption of the drug to dangerous levels. So patients should be told to avoid heating pads, electric blankets or hot baths while the patch is in place, and let their doctors know if they develop a temperature above 102 degrees.
• There have also been cases where children found used patches in the trash and applied them to their own bodies, and died as a result. And so patients should be warned to dispose of the patches by folding them in half and flushing them down the toilet.

ISMP Canada has reported on Fentanyl patch overdoses.  To view the video please click the following link:

http://www.ismp-canada.org/download/CTVFentanylPatchOverdosesContinue2007SEP04.wmv

FDA PATIENT SAFETY NEWS - The U.S. Food & Drug Administration has released a video regarding: “Cardiovascular and Psychiatric Risks with ADHD Drugs”

The information contained in the video is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA

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Details

Patients with Attention Deficit Hyperactivity Disorder(ADHD) who are taking stimulant drugs such as Adderall (amphetamine-dextroamphetamine), Ritalin (methylphenidate) and Strattera (atomoxetine hydrochloride) will soon be given a Patient Medication Guide each time the prescription is filled.

The medication guide will warn that there have been reports of sudden death in children and adolescents with pre-existing structural cardiac abnormalities or other serious heart problems who were taking stimulant drugs to treat their ADHD. Sudden death, stroke and MI have also been reported in adults with underlying risk factors for these events who took ADHD drugs.

The causative role of the stimulants is not clear because pre-existing heart problems themselves carry an increased risk of sudden death. Nevertheless, patients with known serious cardiac problems should generally not use stimulant drugs.

The medication guide will also warn about a slight increased risk for drug-related psychiatric adverse events, such as hearing voices, paranoia or mania, even in patients who did not have previous psychiatric problems.

FDA recommends that patients who may be treated with these drugs work with their health care provider to develop a treatment plan that includes a careful health and family history, and an evaluation of current health status, especially for cardiovascular and psychiatric conditions. Patients should contact a doctor promptly if symptoms develop that are suggestive of heart disease, or of new or worsening psychiatric problems.

ADHD Drugs:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product)
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride)
• Metadate CD(methylphenidate hydrochloride)
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules
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FDA PATIENT SAFETY NEWS - The U.S. Food & Drug Administration has released a video regarding Procrit (epoetin alfa), Aranesp (darbepoetin alfa), and Epogen (epoetin alfa).

The information contained in the video is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA

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Details

FDA has issued a Public Health Advisory which summarizes several recent safety concerns with the use of erythropoiesis stimulating agents (ESAs). These products, marketed as Procrit (epoetin alfa), Aranesp (darbepoetin alfa), and Epogen (epoetin alfa), stimulate the production of red blood cells. They are used to reduce the number of red blood cell transfusions given to patients with certain serious conditions who are, or may become, anemic.

FDA is re-evaluating the safe use of these products because a number of recent studies have shown an increased risk of serious and life-threatening side effects and a greater number of deaths in patients treated with ESAs. In one study of patients with chronic kidney failure there was an increased number of deaths and non-fatal heart attacks, strokes, heart failure, and blood clots when product dosages were adjusted to maintain hemoglobin levels higher than 12 g/dL.

In another study, patients with head and neck cancer receiving radiation therapy had a higher chance of death and faster tumor growth when ESA doses achieved hemoglobin levels higher than 12 g/dL.

Another study showed that cancer patients who were not on chemotherapy died sooner and did not require fewer blood transfusions when they were given these agents. And in yet another study, patients scheduled for orthopedic surgery who received ESAs to reduce perioperative blood transfusions had more blood clots than those not given an ESA.

The FDA Advisory contains a number of recommendations for prescribing these agents:

• Consider both the risks of transfusions and those of ESAs when deciding to prescribe these products.

• Adjust the dose of ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions.

• Monitor patients’ hemoglobin levels to ensure they don’t exceed 12 g/dL.

In addition, prescribers should understand that there are no data to support claims that ESAs can improve quality of life for cancer patients whose anemia is caused by chemotherapy, or for HIV-positive patients whose anemia is caused by AZT. Also, these agents have not been shown to improve the outcomes of chemotherapy treatment.

The manufacturers of Procrit, Aranesp and Epogen have agreed to change the labeling for these products to reflect the new safety information and to provide additional instructions for their use.

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If you or a loved one has suffered from side effects linked to Procrit, Aranesp or Epogen, you should contact us immediately. You may be entitled to compensation and we can help.

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