Jolie Rouge
02-01-2008, 06:39 AM
FDA warns of risks from epilepsy drugs
1 hour, 1 minute ago
WASHINGTON - Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned Thursday in an alert to doctors.
The FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.
Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.
Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.
What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA concluded.
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
The FDA began investigating if epilepsy drugs pose any suicide risk in 2005. It analyzed data from 11 well-known anti-seizure drugs including Pfizer Inc.'s Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote — but the FDA said it expected the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels.
Skipping epilepsy medication can result in seizures. An FDA spokeswoman said only that patients should ask a doctor before making medication changes.
But the agency's letter to doctors advised them to:
_Balance the risk with the patients' need for the drug.
_Tell patients and their families about the risk so they can be aware of changes in mood.
_Make sure patients and families know to contact a doctor if someone experiences common suicide warning signs, such as talking or thinking about hurting yourself, becoming preoccupied with death, withdrawal, becoming depressed or worsening depression, and giving away prized possessions.
http://news.yahoo.com/s/ap/20080201/ap_on_he_me/epilepsy_drugs;_ylt=AtI9RqLoaywfLtuzobQs51Cs0NUE
On the Net: Food and Drug Administration: http://www.fda.gov
Atkins-Like Diet Cuts Epileptic Seizures
By Steven Reinberg - HealthDay Reporter
Thu Jan 31, 11:46 PM ET
THURSDAY, Jan. 31 (HealthDay News) -- Adults with epilepsy who have failed other treatments may be able to dramatically reduce their number of seizures by following a modified Atkins-like diet, Johns Hopkins researchers report.
The high-protein, low-carbohydrate diet has already been shown to be valuable in controlling seizures in children, and now results from a small study suggest that the diet also works for adults. "There are a lot of adults with very bad seizures. There are a lot of adults who have failed medicines and are not candidates for other treatments," said lead researcher Dr. Eric H. Kossoff, an assistant professor of neurology and pediatrics at Johns Hopkins School of Medicine.
For the study, Kossoff's team gave the diet to 30 adults who had unsuccessfully tried at least two anti-convulsant drugs and had an average of 10 seizures a week. The eating plan restricts patients to 15 grams of carbohydrates a day. Most of the calories come from fats such as eggs, meats, oils and heavy cream. In addition, patients are free to eat as much protein and no-carb drinks as they want.
"There was good news and bad news," Kossoff said. "The good news was it worked. The bad news it was tough. About 30 percent of the patients stopped the diet. This happened even in patients who had good seizure control who thought the diet was still too tough to do."
After a month on the diet, half the patients reported suffering 50 percent fewer seizures. At three months, about one-third of the patients cut the frequency of seizures by half.
However, by three months, one-third of the patients had dropped out of the study because they found the diet too restrictive, Kossoff said. The diet's side effects, such as increases in cholesterol or triglycerides, were mild, Kossoff noted.
After six months on the diet, 14 patients continued with it, even though the study was over, he said.
The findings are published in the February issue of the journal Epilepsia.
No one knows how the diet works to reduce seizures, Kossoff said. And, most people find it too hard to follow, so it's probably not a long-term solution for most people with epilepsy, he added.
He also noted that patients who go on the diet need to continue with it, perhaps for years to keep seizures under control.
But Kossoff thinks the diet can be simplified to make it easier to follow. "We are looking at less time in the clinic and fewer restrictions and without a dietitian," he said.
Dr. Gholam Motamedi, director of the epilepsy service at Georgetown University Hospital, thinks the diet can be useful for patients who have no other options. "The study is promising, especially given that patients with refractory epilepsy in particular -- those who are not surgical candidates -- are left with not much hope," he said.
Normally, the plan for these patients is to try a combination of different drugs or to use vagus nerve stimulation, but none of these options offers much hope of seizure control, Motamedi said. "Therefore, having another modality available is always welcomed by the neurologists," he said. "It also encourages basic research looking for insight to the underlying reasons for epilepsy."
For more on epilepsy, visit the Epilepsy Foundation.
http://www.epilepsyfoundation.org/
1 hour, 1 minute ago
WASHINGTON - Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned Thursday in an alert to doctors.
The FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.
Very rarely were suicidal thoughts or behavior reported. Still, the FDA found drug-treated patients did face about twice the risk: 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.
Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.
What that means: For every 1,000 patients, about two more drug-treated patients experienced suicidal thoughts than placebo-takers, FDA concluded.
Anti-seizure drugs are used for a variety of illnesses in addition to epilepsy, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.
The FDA found drug-treated patients were at increased risk no matter their diagnosis, but that the risk was highest for epilepsy sufferers.
The FDA began investigating if epilepsy drugs pose any suicide risk in 2005. It analyzed data from 11 well-known anti-seizure drugs including Pfizer Inc.'s Neurontin, Novartis AG's Tegretol and Abbott Laboratories' Depakote — but the FDA said it expected the risk applied to every epilepsy drug. The FDA said it would work with manufacturers to add the warning to product labels.
Skipping epilepsy medication can result in seizures. An FDA spokeswoman said only that patients should ask a doctor before making medication changes.
But the agency's letter to doctors advised them to:
_Balance the risk with the patients' need for the drug.
_Tell patients and their families about the risk so they can be aware of changes in mood.
_Make sure patients and families know to contact a doctor if someone experiences common suicide warning signs, such as talking or thinking about hurting yourself, becoming preoccupied with death, withdrawal, becoming depressed or worsening depression, and giving away prized possessions.
http://news.yahoo.com/s/ap/20080201/ap_on_he_me/epilepsy_drugs;_ylt=AtI9RqLoaywfLtuzobQs51Cs0NUE
On the Net: Food and Drug Administration: http://www.fda.gov
Atkins-Like Diet Cuts Epileptic Seizures
By Steven Reinberg - HealthDay Reporter
Thu Jan 31, 11:46 PM ET
THURSDAY, Jan. 31 (HealthDay News) -- Adults with epilepsy who have failed other treatments may be able to dramatically reduce their number of seizures by following a modified Atkins-like diet, Johns Hopkins researchers report.
The high-protein, low-carbohydrate diet has already been shown to be valuable in controlling seizures in children, and now results from a small study suggest that the diet also works for adults. "There are a lot of adults with very bad seizures. There are a lot of adults who have failed medicines and are not candidates for other treatments," said lead researcher Dr. Eric H. Kossoff, an assistant professor of neurology and pediatrics at Johns Hopkins School of Medicine.
For the study, Kossoff's team gave the diet to 30 adults who had unsuccessfully tried at least two anti-convulsant drugs and had an average of 10 seizures a week. The eating plan restricts patients to 15 grams of carbohydrates a day. Most of the calories come from fats such as eggs, meats, oils and heavy cream. In addition, patients are free to eat as much protein and no-carb drinks as they want.
"There was good news and bad news," Kossoff said. "The good news was it worked. The bad news it was tough. About 30 percent of the patients stopped the diet. This happened even in patients who had good seizure control who thought the diet was still too tough to do."
After a month on the diet, half the patients reported suffering 50 percent fewer seizures. At three months, about one-third of the patients cut the frequency of seizures by half.
However, by three months, one-third of the patients had dropped out of the study because they found the diet too restrictive, Kossoff said. The diet's side effects, such as increases in cholesterol or triglycerides, were mild, Kossoff noted.
After six months on the diet, 14 patients continued with it, even though the study was over, he said.
The findings are published in the February issue of the journal Epilepsia.
No one knows how the diet works to reduce seizures, Kossoff said. And, most people find it too hard to follow, so it's probably not a long-term solution for most people with epilepsy, he added.
He also noted that patients who go on the diet need to continue with it, perhaps for years to keep seizures under control.
But Kossoff thinks the diet can be simplified to make it easier to follow. "We are looking at less time in the clinic and fewer restrictions and without a dietitian," he said.
Dr. Gholam Motamedi, director of the epilepsy service at Georgetown University Hospital, thinks the diet can be useful for patients who have no other options. "The study is promising, especially given that patients with refractory epilepsy in particular -- those who are not surgical candidates -- are left with not much hope," he said.
Normally, the plan for these patients is to try a combination of different drugs or to use vagus nerve stimulation, but none of these options offers much hope of seizure control, Motamedi said. "Therefore, having another modality available is always welcomed by the neurologists," he said. "It also encourages basic research looking for insight to the underlying reasons for epilepsy."
For more on epilepsy, visit the Epilepsy Foundation.
http://www.epilepsyfoundation.org/