Archive for the ‘Painkillers’ Category

Self-Dosing Pain Medications - be careful!

Tuesday, December 16th, 2008

painkillersAllowing patients to control their own pain medication intravenously is four times more likely to cause the patient harm than other medications, a new study says.

The report, published in the December issue of The Joint Commission Journal on Quality and Patient Safety, shows that most mistakes involving intravenous patient-controlled analgesia (PCA) resulted from either human error, equipment issues or communication problems that led to the patient receiving the wrong dosage or drug. PCA errors also tended to be more severe — harming patients and requiring clinical interventions — than other types of medication errors.

“The entire PCA process is highly complex,” lead author Rodney W. Hicks, the UMC Health System Endowed Chair for Patient Safety at Texas Tech University Health Sciences Center in Lubbock, said in a news release issued by the journal’s publisher. “PCA orders must be written, reviewed, and then accurately programmed into sophisticated delivery devices for patients to be pain free. Such complexity makes PCA an error-prone process. Health care organizations should now plan to make the process safer.”

The five-year study uncovered more than 9,500 PCA errors. Patients were harmed in 6.5 percent of these incidents, compared to 1.5 percent for general medication errors.

In PCA, a computerized pump with a syringe of prescribed pain medication is hooked straight into a patient’s intravenous (IV) line. The patient can self-dose by pushing a button.

Hicks and his co-authors make three recommendations to reduce future PCA errors:
Simplify the equipment. Easier step-by-step setup instructions could cut down on programming errors by caregivers setting up the PCA machine’s dosage levels.
Use bar codes and keep an electronic medication administration record. Making a standard practice out of independent double-checks of the PCA orders, the product, and the PCA device could help prevent giving patients’ the wrong medication.
Design and use easy, standardized forms for PCA. Use of universal forms by pharmacists could correct communication issues in the process.

Painkillers Linked to Increase in Overdose Deaths

Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests.

West Virginia, in particular, has seen a large increase in such unintentional deaths, say government researchers, who have uncovered patterns of “doctor shopping” for drugs and overdosing on medications not used as prescribed.
(more…)

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Giving pain medications to children

Friday, February 8th, 2008

PainkillersGiving your child medications, even over-the-counter medicines, should always be carefully monitored by your doctor.

The American Academy of Family Physicians offers these suggestions before you give any pain medication to your child:

  • If a person younger than age 18 has the flu or chickenpox, never give the person aspirin, which could lead to a rare but deadly condition called Reye’s Syndrome.
  • Acetaminophen (the active ingredient in Tylenol) is a generally safe painkiller for young children.
  • Be careful about giving ibuprofen to children who are allergic to aspirin, as they may also be allergic to ibuprofen.
  • Pain relievers may be dangerous for children with asthma, so don’t administer them without a doctor’s consent.
  • Be careful not to give your child too much of the same medication. Sometimes the same active ingredient can be found in more than one medication.

Pain Medication in Young Children: How Are We Doing?

Not very well, especially for children younger than 2 years.

Doctors are known to do a poor job of treating pain. How do we do in treating pain in preverbal and very young children? To answer this question, these authors performed a retrospective chart review of patients 6 months to 10 years old who presented to a pediatric emergency department between 1999 and 2000 with isolated long-bone fractures or second- or third-degree burns.

Patients were excluded if they had closed head injury, chest or abdominal trauma, or a history of developmental delay or other neurologic impairment; 180 children were enrolled. The use of analgesics was assessed in 2 age groups: very young (6 to 24 months) and school-aged (6 to 10 years) children. More very young children than school-aged children did not receive analgesic agents (64.6% vs. 47.6%). When analgesics were used, very young patients were less likely to receive opioids (16.7% vs. 44.0%, respectively) and more likely to receive over-the-counter products (18.8% vs. 8.3%, respectively). Injury patterns differed significantly in the 2 age groups: Second-degree burns were more common in the very young group, and displaced fractures were more common in the school-aged group. Among children with nondisplaced fractures and among those with third-degree burns, there was no difference in analgesic treatment between the very young and school-aged groups.

Pain Medications

Over-the-Counter Pain Relievers

Over-the-counter (OTC) pain relievers include:

  • Acetaminophen (Tylenol, Aspirin Free Excedrin)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs; aspirin, Motrin, Aleve and Orudis KT)
  • Topical Corticosteroids (Cortaid and Cortizone)

Both acetaminophen and NSAIDs reduce fever and relieve pain caused by muscle aches and stiffness, but only NSAIDs can also reduce inflammation (swelling and irritation). Acetaminophen and NSAIDs also work differently. NSAIDs relieve pain by reducing the production of prostaglandins, which are hormone-like substances that cause pain. Acetaminophen works on the parts of the brain that receive the “pain messages.” NSAIDs are also available in a prescription strength that can be prescribed by your physician.

Topical pain relievers are also available without a doctor’s prescription. These products include creams, lotions, or sprays that are applied to the skin in order to relieve pain from sore muscles and arthritis. Some examples of topical pain relievers include Aspercreme, Ben-Gay, Icy Hot and Capzasin-P. Corticosteroid creams are also available.

Prescription Pain Relievers

Prescription pain relievers include:

  • Corticosteroids
  • Opioids
  • Antidepressants
  • Anticonvulsants (antiseizure medications)

What Are Corticosteroids?

Prescription corticosteroids provide relief for inflamed areas of the body by easing swelling, redness, itching and allergic reactions. Corticosteroids can be used to treat allergies, asthma and arthritis. When used to control pain they are generally given in the form of pills or injections. Examples include: Deltasone, Hydeltrasol and Solu-Medrol.

Prescription corticosteroids are strong medicines and may have serious side effects, including:

  • Weight gain
  • Upset stomach
  • Headache
  • Mood changes
  • Trouble sleeping
  • Weakened immune system

To minimize these potential side effects, corticosteroids are prescribed in the lowest dose possible for as short of a length of time as needed to relieve the pain. Efforts are underway to develop safer corticosteroids.

What Are Opioids?

Opioids are narcotic pain medications that contain natural, synthetic or semi-synthetic opiates. Opioids are often used for acute pain, such as short-term pain after surgery. Some examples of opioids include:

  • Morphine
  • Fentanyl
  • Oxycodone
  • Codeine

Opioids are effective for severe pain and do not cause bleeding in the stomach or other parts of the body as can other types of pain relievers. It is rare for people to become addicted to opioids if the drugs are used to treat pain for a short period of time.

Side effects of opioids may include:

  • Drowsiness
  • Nausea
  • Constipation
  • Itching
  • Breathing problems
  • Addiction

What Are Antidepressants?

Antidepressants are drugs that can treat pain and/or emotional conditions by adjusting levels of neurotransmitters (natural chemicals) in the brain. These medications can increase the availability of the body’s signals for well-being and relaxation, enabling pain control for people with chronic pain conditions that do not completely respond to usual treatments.

Chronic pain conditions treated by low-dose antidepressants include some types of headaches (like migraines) and menstrual pain. Some antidepressant medications include:

  • Selective Serotonin Reuptake Inhibitors (SSRIs) such as Celexa, Prozac, Paxil, and Zoloft
  • Tricyclic antidepressants such as Elavil, Norpramin Sinequan, Tofranil, and Pamelor
  • Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRIs) such as Effexor and Cymbalta

These drugs require a steady dose of the medicine build up in the body over a period of time to work. The doses needed to treat pain are often lower than those needed to treat depression.

In general, antidepressants have fewer long-term side effects than frequent, ongoing use of other pain medicines. Generally, SSRIs and SSNRIs have fewer side effects than tricyclic antidepressants. The most common side effects with antidepressants include:

  • Blurry vision
  • Constipation
  • Difficulty urinating
  • Dry mouth
  • Fatigue
  • Nausea
  • Headache

What Are Anticonvulsants?

Anticonvulsants are drugs typically used to treat seizure disorders. Some of these medications are shown to be effective in treating pain as well. The exact way in which these medicines control pain is unclear but it is thought that they minimize the effects of nerves that cause pain. Some examples include Tegretol, Neurontin and Lyrica.

In general they are well tolerated. The most common side effects include:

  • Drowsiness
  • Dizziness
  • Fatigue
  • Nausea

Other Pain Treatments

Another means of topical pain relief comes in the form of a Lidoderm patch, which is a prescription medication.

If your pain is not relieved by the usual treatments, your doctor may refer you to a pain management specialist. Doctors who specialize in pain management may try other treatments such as certain types of physical therapy or other kinds of medicine. They may also recommend TENS, a procedure that uses patches placed on the skin to send signals that stop pain.

Patient-controlled analgesia (PCA) is a method of pain control that allows the patient to control the amount of pain medication administered. This is often used in the hospital to treat pain. By pushing a button on a computerized pump, the patient receives a pre-measured dose of pain medicine. The pump is connected to a small tube that allows medicine to be injected intravenously (into a vein), subcutaneously (just under the skin), or into the spinal area.

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Vioxx - a $4.85 billion cost painkiller

Friday, November 9th, 2007

VioxxMerck & Co. said it will pay $4.85 billion to end thousands of lawsuits over its painkiller Vioxx in what is believed to be the largest drug settlement ever.

Merck faced personal injury lawsuits representing 47,000 plaintiffs, and about 265 potential class action cases, filed by people or family members who claimed the drug proved fatal or injured its users. The agreement covers cases filed in both federal and state courts.

Negotiating teams met more than 50 times in eight states and spoke hundreds of times over the telephone to hammer out the deal, according to attorneys.

“I’m very happy with it,” Chris Seeger, one of the six plaintiff lawyers who helped negotiate the settlement, said Friday. “It’s a tremendous way to resolve this litigation.”

Merck pulled Vioxx from the market Sept. 30, 2004 after its researchers determined the then-blockbuster painkiller doubled risk of heart attacks and strokes.

To qualify for a settlement, plaintiffs must have filed claims by Thursday and meet several criteria, including medical proof that they suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support a presumption that they were ingested within two weeks before injury.

That is a big concession by Merck, which has long claimed that Vioxx caused harm only after 18 months of use.

Those claims were dismissed by independent scientists and plaintiffs lawyers.

Merck stressed that the agreement is not a class action settlement and that it is not admitting fault.

Company executives and attorneys said as recently as last month that every case would be fought individually.

Analyst Steve Brozak of WBB Securities called Merck’s’ handling of the litigation “a Harvard casebook study of how to deal with a problematic product.”

Investors seemed to agree, as Merck shares jumped 4.6 percent, or $12.50, to $57.27 Friday.

Analysts predicted early on that liability could reach $50 billion, but after losing its first case in a $253 million verdict, Merck has won a string of civil cases.

Merck may now have put the uncertainty of millions of dollars in legal costs behind it, though it has been fairly successful fighting cases individually, winning 10 of 15 court verdicts to date.

The company said last month it had added $70 million to its reserves for defending lawsuits. As of Sept. 30, Merck had reserved a total of $1.92 billion for legal expenses and spent a total of $1.2 billion.

The deal becomes binding only if 85 percent of the plaintiffs in about 26,600 lawsuits agree to drop their cases. It was finalized in the early morning hours after attorneys for Merck and the plaintiffs met with three of the four judges overseeing nearly all Vioxx claims.

Seeger said the deal was put in motion last December when three key judges pushed the parties to open out-of-court talks.

“Every claimant is going to be compensated” once their claim is validated, he said.

Seeger believes it is the largest settlement ever in the industry and said he will recommend that his 2,000 clients accept the deal.

Payments would vary, depending on severity of injuries and the length of time that Vioxx was used.

“The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount,” Richard T. Clark, chairman, president and chief executive officer of Merck, said in a statement.

Attorneys for both sides were to present the deal Friday morning to U.S. District Judge Eldon E. Fallon in New Orleans.

“In light of significant costs and delay that would result in protracted litigation, the settlement program will ensure that those who suffered injuries as a result of Vioxx are compensated fairly and efficiently,” according to a statement from one of the lead plaintiffs law firms in the case, Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, Ala.

Merck agrees to pay $4.85 bln in Vioxx settlement

Merck & Co has agreed to pay $4.85 billion to settle claims that its painkiller Vioxx caused heart attacks and strokes in thousands of users, the drugmaker said on Friday.

The agreement covers lawsuits filed against the company in U.S. courts, resolving a major legal battle that has dogged the drugmaker since it pulled Vioxx off the market three years ago.

Merck recalled the popular painkiller, which had $2.5 billion in annual sales, in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for more than 18 months.

In the settlement, reached with representatives of plaintiffs in federal and state courts, Merck did not admit Vioxx caused patient injury and did not admit fault.

The drugmaker, whose shares rose nearly 2 percent in pre-market trade on news of the deal, said it would take a charge of $4.85 billion to cover costs of the agreement.

The settlement marks a shift in strategy for Merck, which previously said it intended to fight Vioxx litigation on a case-by-base basis rather than consider a broad settlement.

“The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding Vioxx product-liability claims in the United States for a fixed amount,” said Richard Clark, chairman, president and chief executive officer of Merck.

The drugmaker said it would still defend all claims not included in the settlement. Since the withdrawal of Vioxx, Merck has won 11 court cases over the drug and lost five.

While it is appealing those cases that it lost, analysts said the settlement will solidify Merck’s future.

“They’re trying to reduce the uncertainty surrounding the costs related to Vioxx,” said Damien Conover, an analyst at Morningstar. “While it will probably bring a little more clarity, I think there are still going to be a lot of cases that won’t settle within this agreement.”

Conover said the cases included in the settlement are likely the weakest cases.

“What you’re going to be left with is a significant number of plaintiffs who will want to address Merck on an individual basis, which means they will likely seek higher compensation,” he said.

Conover said that while it is difficult to gauge how many people will try to fight Merck alone, he estimates the company could be facing 1,000 to 2,000 outstanding claims and could face more than $1 billion in additional costs.

Mike Ward of Nomura Securities in London said a settlement value of less than $5 billion likely would be taken positively by the market, noting that litigation over Wyeth’s Phen-Fen diet drug was only now coming slowly to a close after 10 years in the courts and over $21 billion in settlement costs.

Merck shares tumbled on news of the withdrawal of Vioxx in 2004, losing more than a third of their market value. But with Merck’s Vioxx victories in court, and a string of successful new medicines, the shares have recouped those losses.

The stock, even with the major litigation drag, has outperformed its peers on the American Stock Exchange pharmaceutical index this year, rising 25 percent, compared with little change in the index.

Merck shares rose to $55.70 in pre-market trade from a Thursday close at $54.77 on the New York Stock Exchange. The stock is trading just below a four-year high of $58.36, reached earlier this month.

!Vioxx was withdrawn from the U.S. market in 2004!

The manufacturer of Vioxx has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes;”flu-like” symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

What is Vioxx?

!Vioxx was withdrawn from the U.S. market in 2004!

Vioxx is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Vioxx works by reducing substances that cause inflammation, pain, and fever in the body.

Vioxx is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.

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