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Drugs that treat epilepsy, depression linked to suicide

From CNN Health:

Some antiseizure drugs used to treat epilepsy as well as depression, chronic pain, migraine, bipolar disorder, and other conditions are associated with a higher risk of suicide and violent death than other drugs in the same class, according to a new study.

Experts caution that patients should not stop taking the drugs -- gabapentin (Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal), tiagabine (Gabitril), and valproate (Depakote) -- without their doctor's permission.

It's still not clear whether these risks are related to the drugs themselves or to underlying mood problems.

Suicidal thinking and acts are "very, very rare," says Carl Bazil, MD, a professor of clinical neurology and the director of the Columbia Comprehensive Epilepsy Center, in New York City.

"The vast majority of patients do not have anything like that." Dr. Bazil was not involved in the research.

The study, published this week in the Journal of the American Medical Association, echoes a 2008 review by the U.S. Food and Drug Administration (FDA) that found that taking anticonvulsants (as this class of drugs is known) roughly doubled the risk of suicidal thoughts and suicide attempts, although the absolute risk remained small -- less than half of 1 percent.

Posted: 5/6/2010 3:49:00 PM

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Popular anticonvulsant drugs raise suicide risks

From Reuters:

Widely used anticonvulsant drugs, including Pfizer's Neurontin and Novartis' Trileptal, may increase the risk of suicide, attempted suicide and violent death in patients taking them for the first time, U.S. researchers said on Tuesday.

Compared with Johnson & Johnson's generic epilepsy drug topiramate or Topamax, the team found an increased risk for suicide in new users of Neurontin, sold generically as gabapentin, GlaxoSmithKline's Lamictal or lamotrigine, Novartis' Trileptal or oxcarbazepine and Cephalon's Gabitril or tiagabine.

In one analysis, the team also found an increased risk of suicide with the drug valproate sold by Sanofi-Aventis as Epilim and as Depakine in the United States by Abbott Laboratories Inc.

In 2008, the U.S. Food and Drug Administration required that all drugs in the anticonvulsant class carry a warning that they double the risk of suicidal thoughts and behaviors, based on a so-called meta-analysis of nearly 200 clinical trials.

But the analysis was not large enough to show which drugs in the class were risky. And they are prescribed for a range of conditions.

Anticonvulsant drugs are chiefly used for patients with epilepsy, but the drugs have been aggressively promoted, in some cases for conditions they are not approved to treat, such as bipolar disorder, pain and migraine headaches.

While doctors are free to prescribe medicines as they see fit, drugmakers are only allowed to promote them for uses approved by the FDA.

Sharp Rise in U.S. Military Psychiatric Drug Use and Suicides

From The Huffington Post:

One in six service members is now taking at least one psychiatric drug, according to the Navy Times, with many soldiers taking "drug cocktail" combinations. Soldiers and military health care providers told the Military Times that psychiatric drugs are "being prescribed, consumed, shared and traded in combat zones."

The Navy Times also noted that there has been a large increase in military suicides. From 2001 to 2009, the Army's official suicide rate increased from 9 per 100,000 soldiers to 23 per 100,000. During that same period, the Marine Corps suicide rate increased from 16.7 per 100,000 soldiers to 24 per 100,000.

A Military Times investigation of records obtained from the Defense Logistics Agency (DLA) revealed that the DLA spent $1.1 billion on psychiatric and pain medications from 2001 to 2009, and that there was a 76 percent increase in psychiatric drugs. DLA records show:

Antipsychotic drugs spiked most dramatically -- orders jumping by more than 200 percent.
• Orders for anti-anxiety drugs and sleeping pills such as Valium and Ambien increased 170 percent.
• Orders for antiepileptic drugs (also known as anticonvulsants) such as Depakote, routinely used as psychiatric medications, increased 70 percent.
• 40 percent increase in antidepressants.

Investigators found that antipsychotic and antiepileptic drugs, approved for bipolar disorder and schizophrenia, are now commonly used to treat post-traumatic stress disorder (PTSD) symptoms such as nightmares, nervousness and anger outbursts. The use of antipsychotic drugs for non-psychotic conditions such as PTSD is called "off-label" prescribing.

In February 2010, Brig. Gen. Loree Sutton, the Army's highest-ranking psychiatrist, reported to Congress that 17 percent of the active-duty force and as much as 6 percent of deployed troops are on antidepressants.

Many of these psychiatric drugs prescribed to service members can also impair motor skills, reduce reaction times, and generally make one more sluggish -- or what soldiers call "stupid." So in addition to antidepressants potentially resulting in increased suicidality, other psychiatric drugs can make deployed soldiers feel less capable of protecting themselves and their buddies.  

Testing of Pregabaline as hot-flash medication for women

From The News-Gazette:

Medical experts have tried everything from herbal remedies to anti-depressants to help relieve hot flashes in menopausal women.

Now, researchers at Carle Clinic and more than 100 other medical sites around the country will begin testing a remedy on women that has already been shown to work for men who get hot flashes as a result of hormone treatments for prostate cancer.

The medication being tested, Pregabalin, is taken orally, and is currently approved to treat nerve pain, fibromyalgia and seizures.

Dr. Kendrith Rowland, principal investigator of oncology research at Carle Clinic, described it as a "safe, non-hormonal drug" that will likely work for women with hot flashes just as it has for men.

Now researchers just need some women willing to try it.

Carle has enrolled nine women in a Pregabalin clinical trial, and is looking for more. Nationwide, the trial will be limited to 192 patients, said Janet Iverson, a clinical research professional at Carle.

It's about time medical science addressed this problem for women, she said.

"We really don't have a good standard of care out there for women who are experiencing this," she added.

Carle is among 123 research locations participating in the Pregabalin trial sponsored by the North Central Cancer Treatment Group based at Mayo Clinic in Rochester, Minn.

Posted: 7/26/2008 1:01:00 PM

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Epilepsy drug eases diabetic neuropathy pain

From Reuters Health:

A review of previous studies indicates that the seizure drug pregabalin (Lyrica) is safe and effective for relieving diabetic neuropathy, the pain that diabetics often experience in their feet and hands.

The analysis of data from seven studies of pregabalin, with dosages of 150, 300, and 600 milligrams daily and study durations from 5 to 13 weeks, is published in the journal Diabetes Care.

Dr. Roy Freeman of Harvard Medical School in Boston and colleagues report that "pregabalin significantly reduced pain and pain-related sleep interference" with all three dosages when divided into three pills taken throughout the day. Only the highest dosage was effective when divided into two pills.

With the 600 mg daily dose, it typically took 4 days for a sustained reduction in pain. With the 300 and 150 mg daily doses, it took 5 days and 13 days, respectively.

While the 600 mg dose was the most effective, it was also the most likely to cause side effects. Common side effects included dizziness, sleepiness, and swelling in the legs and arms.

Weight gain, which occurred in some patients, was directly related to the pregabalin dose and the duration of treatment.

"The underlying cause of the weight gain is not known," the authors note. However, the weight gain did not affect the patients' ability to control blood sugar levels.

Posted: 7/18/2008 3:32:00 PM

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Double the Risk of Suicide Not Enough to Warrant Black Box Warning

From MedHeadlines:

In January, the US Food and Drug Administration (FDA) began the process of evaluating 199 studies of anti-seizure drugs commonly prescribed for epilepsy and other disorders due to reports of suicidal behaviors in patients taking them. Their findings led them to request a black-box warning be placed on the prescription labels of all 11 drugs under evaluation because the risk of suicide doubled when taking these drugs. The findings of the FDA evaluation were presented for discussion to a 20-member panel of advisers who voted unanimously on Thursday to deny the request for the black-box warning.

A black-box warning is the strongest warning of danger available to the pharmaceutical industry. Instead, the panel approved sending medication guides to physicians that describe the increased risk of suicide posed by these medications.

The panel said the risk of suicide wasn’t high enough to warrant the black-box warning and that to allow it might deter physicians from prescribing it. The opinion of the panel is taken very seriously by the FDA and the agency usually follows its recommendations.

The drugs in question include both the brand name and the generic name of Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate, Gabapentin (Neurontin), Lamotrigine (Lamictal), Levetiracetam (Keppra), Oxcarbazepine (Trileptal), Pregabalin (Lyrica), Tiagabine (Gabitril), Topiramate (Topamax), Valproate (Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (Zonegran). These drugs are often prescribed to treat epilepsy, migraine headaches, bipolar disorder, and several other conditions.

While the FDA does not think there is reason to alter or interrupt treatment if a patient is taking any of these medications, they do advise caregivers to pay special attention to changes in mood, behavior, and the actions of the individual patient.

Posted: 7/14/2008 4:42:00 PM

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Patients battle perception of fibromyalgia

From Lubbock Online:

Imagine being in pain most of the time, over most of your body. You go to your doctor, who gives you medicine that doesn't help. You go back to your doctor several times, but the pain never gets better. You begin to feel discouraged, you stop going to the doctor and you start to live with the pain.

"That is the picture of unrecognized fibromyalgia," said Dr. Anne C. Epstein, an internal medicine specialist who has a special interest in fibromyalgia.

Four percent of the population has fibromyalgia, said Dr. Naga Bushan, a rheumatologist. It is more common among women, he said.

Fibromyalgia, as Epstein explained, is a condition in which a person is in pain nearly all the time, and the pain is all over the body. But, she said, it's not a normal pain. It doesn't get better or worse with exercise.

Epstein said there is nothing wrong with the parts of the body that hurt. Instead the disorder is in the chemical messages that the nerves use to send pain sensation to the brain.

It is unclear what causes fibromyalgia, but there are a number of causes that seem to trigger it, Epstein said. Injury, such as from an automobile accident, or stress can bring on fibromyalgia, she said.

But pain isn't the only aspect of fibromyalgia, both doctors said.

Chronic headaches, memory problems, tingling in hands and feet, irritable bowel syndrome and depression may accompany the pain in people with fibromyalgia, Bushan said.

Fibromyalgia is a treatable condition.

Pain unrelated to the fibromyalgia, such as localized pain and muscle and joint pains, must be managed in someone with fibromyalgia. Fatigue must be managed as well.

Several medications have been shown to help people with fibromyalgia, she said. Some antidepressants, anticonvulsants and a new medication, pregabalin (Lyrica) , have been shown to help people with fibromyalgia.

In addition to medication, Epstein said a regular sleep, eating and exercise program can help. Even gentle physical therapy can be beneficial for someone with fibromyalgia, she said.

Bushan said education about available medications and their side effects is a very important part of treatment. He also said a psychologist can help someone with fibromyalgia learn to cope with the condition, as well as help the person to learn relaxation techniques.

Posted: 5/23/2008 9:00:00 AM

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