Yourlawyer.com (Trileptal News) http://www.yourlawyer.com/topics/overview/trileptal Wed, 23 Jul 2014 05:15:46 -0400 Wed, 23 Jul 2014 05:15:46 -0400 pixel-app en Epilepsy Drugs to Carry Suicide Warnings http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-carry-suicide-warnings Wed, 17 Dec 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-carry-suicide-warnings Epilepsy drugs must now carry warnings about their suicide risks, the Food & Drug Administration (FDA) has announced.  The drugs subject to the new warning include those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.  Epilepsy drugs on the list are:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER, Depakene)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal) Phenytoin (marketed as Dilantin Suspension)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Zonisamide (marketed as Zonegran)

Any available generic versions of these drugs will also carry the new epilepsy drugs, the FDA said.

The FDA said its actions were based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo, the agency said.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The FDA added that the biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

In addition to the suicide warning, the FDA is also requiring the drugs' manufacturers to submit f a Risk Evaluation and Mitigation Strategy for each medication , including a Medication Guide for patients. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

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Epilepsy Drugs Targeted for Black Box Suicide Warning http://www.yourlawyer.com/articles/title/epilepsy-drugs-targeted-for-black-box-suicide-warning Tue, 08 Jul 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/title/epilepsy-drugs-targeted-for-black-box-suicide-warning epilepsy drugs to add a black box warning to their labels about their association with suicidal thoughts and behavior. The Food & Drug Administration (FDA) is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday.   

In total, 11 epilepsy drugs could get the new black box warning - the FDA's strongest safety notice. They include:

  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
  • Felbamate (marketed as Felbatol)
  • Gabapentin (marketed as Neurontin)
  • Lamotrigine (marketed as Lamictal)
  • Levetiracetam (marketed as Keppra)
  • Oxcarbazepine (marketed as Trileptal)
  • Pregabalin (marketed as Lyrica)
  • Tiagabine (marketed as Gabitril)
  • Topiramate (marketed as Topamax)
  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
  • Zonisamide (marketed as Zonegran)

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, 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 epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

According to the FDA, three of the 11 drugs studied showed no clear signal of suicidal problems.  However, the agency is still leaning towards including the warning on all the drugs, as sample sizes in some of the studies might have been too small to accurately assess suicide risks.  One of the issues the agency will ask the panel to address at Thursday's meeting is whether all of the drugs, or just some of them, should be subjected to the black box.

The FDA is not bound to follow the recommendations of its advisory panels, but it usually does so.

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Epilepsy Drugs to Get Suicide Warnings, FDA Confirms http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-get-suicide-warnings-fda-confirms Fri, 06 Jun 2008 00:00:00 -0400 http://www.yourlawyer.com/articles/title/epilepsy-drugs-to-get-suicide-warnings-fda-confirms US regulators are very close to finalizing new suicide warnings for 11 epilepsy drugs, The Wall Street Journal reported today.  This past January, the Food & Drug Administration (FDA) issued an Early Communication announcing a safety review of the epilepsy drugs after a study showed they increased patients' risk of suicidal thoughts and behavior.

The 11 epilepsy drugs slated for a new suicide warning are:

In addition to treating epilepsy, the anti-seizure medications are used for a variety of other illnesses, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a risk of suicide.

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005.  In doing so, 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 epilepsy medications and another 16,000 given dummy pills. 

 According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.  The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.  For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.

In an interview with The Wall Street Journal, Russell Katz, director the FDA's neuropharmacological drug division confirmed the suicide warnings are coming.  "We are working on the labeling changes that we want to get to the companies," he said.  An FDA advisory panel is slated to take up the issue of epilepsy drugs and suicide on July 10, but the Journal speculated the new warnings could come even sooner than that.

At least one drug maker, Pfizer Inc., is less than pleased at this development.  Pfizer disputed the FDA's analysis in a forum this week sponsored by the Epilepsy Study Consortium in New York.  Pfizer especially disputes the inclusion of Lyrica - one of the company's biggest growth drivers -on the FDA's warning list.  Pfizer said that Lyrica accounted for only 6.3% of the total 142 suicidal events cited by the FDA analysis.  But the FDA is sticking to its guns, and the new suicide warning will apply to all 11 epilepsy drugs.

Most other epilepsy drug makers are resigned to the label changes, according to the Journal.  GlaxoSmithKline, the maker of Lamictal, approached the FDA this year to volunteer changes regarding possible suicidal-behavior risks.  Other drug makers may have chosen not to challenge the FDA on suicide warnings because their medications are no longer as lucrative as they once were, as patents on many epilepsy drugs have, or are close to, expiring.

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Epilepsy Drug No Help Against Migraines http://www.yourlawyer.com/articles/title/epilepsy-drug-no-help-against-migraines Tue, 12 Feb 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/title/epilepsy-drug-no-help-against-migraines epilepsy drug oxcarbazepine was strongly believed to have prevented migraine headaches; however, a new study suggests that this is not so.  Epilepsy drugs such as oxcarbazepine have long been used for migraine prevention, according to Dr. Stephen Silberstein of the Jefferson Headache Center in Philadelphia and associates.  Oxcarbazepine—marketed as Trileptal by Novartis or Trexapin by Taro—is used alone or in combination with other medications to treat certain types of seizures in people who have epilepsy and is in a class of medications called anticonvulsants.  It works by decreasing abnormal excitement in the brain and has also been used to treat bipolar disorder.  

In a nearly five-month long study, investigators randomly assigned 170 men and women with a history of migraine to either a daily dose of oxcarbazepine or an inactive placebo.  Both groups included patients who experienced between three and  nine migraine attacks within a month.  The results of the study showed that there was no difference between the group receiving a daily dose of oxcarbazepine and the group receiving a daily placebo dose in the change in the number of migraine attacks experienced from the beginning to the end of the study.  

Likewise, the study revealed the severity of migraine attacks and the amount of acute rescue medication required for those attacks was not affected by treatment allocation of either the medication or the placebo.  "The results of this trial do not support preliminary data which had suggested oxcarbazepine was effective in preventing migraine," Silberstein noted in a written pistatement.  "While several epilepsy drugs have been used for decades to prevent migraine, oxcarbazepine did not prevent migraine in this study despite it being shown to be safe and well-tolerated."

Migraine is a debilitating headache that usually causes pulsing or throbbing pain in one area of the head.  During migraines, people are very light and sound sensitive and may become nauseated and vomit.  Migraine is three times more common in women than in men and some patients can tell when they are about to have a migraine because they see flashing lights or zigzag lines; temporarily lose their vision; or experience other sensory anomalies, such as smelling citrus.  It is believed that there are a variety of triggers for migraine, including anxiety or stress, a lack of food or sleep, exposure to light, and hormonal changes (in women).  

Silberstein also noted that the three epilepsy drugs that most effectively prevent migraine—topiramate, divalproex, and gabapentin—each have several mechanisms by which they treat migraine, including the ability to regulate a brain chemical known as GABA.  In contrast, oxcarbazepine has no apparent activity on GABA.  Silberstein says it is possible that epilepsy drugs must be able to regulate brain chemical in order to prevent migraine.  GABA—or gamma-aminobutyric acid—is an inhibitory neurotransmitter found in the nervous system, that is, GABA helps the nerve impulses cross synapses and communicate with one another.  Research has demonstrated GABA to be a very effective analgesic, eliminating pain from chronic conditions such as arthritis, lower back pain, and migraine.

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Epilepsy Drugs Double Suicide Risks, FDA Warns http://www.yourlawyer.com/articles/title/epilepsy-drugs-double-suicide-risks-fda-warns Sat, 02 Feb 2008 00:00:00 -0500 http://www.yourlawyer.com/articles/title/epilepsy-drugs-double-suicide-risks-fda-warns Epilepsy drugs have been linked to a increased risk of suicidal thoughts and behavior, the Food & Drug Administration (FDA) warned this week.  According  to an FDA analysis, people taking antiepileptic drugs are twice as likely to experience suicidal thoughts or behavior than those taking placebo.

The FDA began investigating if epilepsy drugs pose any suicide risk in 2005.  In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The  antiepileptic medications studied by the FDA  included:

•    Carbamazepine(marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
•    Felbamate (marketed as Felbatol)
•    Gabapentin (marketed as Neurontin)
•    Lamotrigine (marketed as Lamictal)
•    Levetiracetam (marketed as Keppra)
•    Oxcarbazepine (marketed as Trileptal)
•    Pregabalin (marketed as Lyrica)
•    Tiagabine (marketed as Gabitril)
•    Topiramate (marketed as Topamax)
•    Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
•    Zonisamide (marketed as Zonegran)

The studies tracked almost 28,000 people given the medications and another 16,000 given dummy pills.  According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers.  The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. There was no clear pattern of risk across age groups.

Overall, four people in the drug-treated groups committed suicide, and none in the placebo groups.  According to the FDA for every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.  Even though the FDA only looked at 11 epilepsy medications, the agency said the suicide warning applied to all epilepsy drugs.

Millions of people  take epilepsy drugs. Such anti-seizure medications 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.
 

Doctors and other healthcare providers where advised by the FDA to balance the risk for suicidal thoughts and behavior with the clinical need for the drug  and to be  aware of the possibility of the emergence or worsening of depression, suicidality, or any unusual changes in behavior.  Healthcare providers where told to inform patients, their families, and caregivers of the potential for an increase in the risk of suicidality so they are aware and able to notify their healthcare provider of any unusual behavioral changes.

Because skipping epilepsy medication can result in seizures, the FDA said  that patients should ask a doctor before making medication changes.  The FDA said patients and their families should pay close attention to any day-to-day changes in mood, behavior and actions.  These changes can happen very quickly so it is important to be mindful of any sudden differences.  Patients and their families should be aware of common warning signs that might be a signal for risk of suicide, inlcuidng  talking or thinking about wanting to hurt themselves or end their lives; withdrawing from friends and family; Becoming depressed or having  depression get worse; becoming preoccupied with death and dying; and giving away prized possessions. If these or any new and worrisome behaviors occur, patients or their families should contact the responsible healthcare professional immediately.

The FDA said it would be working with manufacturers of marketed epilepsyc drugs to include this new information about suicide risks in the labeling for these products. The agency anticipates that labeling changes will be applied broadly to the entire class of drugs. The  FDA is also planning to discuss the suicide data at an upcoming advisory committee meeting.

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FDA panel to review safety of 16 drugs in children http://www.yourlawyer.com/articles/title/fda-panel-to-review-safety-of-16-drugs-in-children Wed, 15 Nov 2006 00:00:00 -0500 http://www.yourlawyer.com/articles/title/fda-panel-to-review-safety-of-16-drugs-in-children A Food and Drug Administration panel is set to meet Thursday to discuss the safety review of 16 drugs, including flu drug Tamiflu, in pediatric patients.

The pediatric advisory committee will evaluate new and updated reports by the FDA staff that include information on the drugs' safety compiled over a year. The panel will then make recommendations that could include label changes or further investigation of adverse events.

The FDA isn't required to follow the panel's suggestions, but it usually does.

Although the panel was to issue an opinion on Tamiflu's label Thursday, on Tuesday its manufacturer, Roche Holding AG (RHHBY), said it would follow the FDA staff's recommendation in the report and update the label to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations.

In its report, the staff said the label should be changed following a review that found 103 cases of "neuropsychiatric adverse events," including the death of a 14-year-old boy who fell after climbing on his condominium balcony's railing.

According to documents posted on the FDA Web site ahead of Thursday's meeting, eight drugs under review didn't raise any safety concerns. They include cholesterol-lowering medications Lipitor from Pfizer Inc. (PFE) and Zocor from Merck & Co. (MRK), Eli Lilly & Co.'s (LLY) cancer drug Gemzar, and Johnson & Johnson's (JNJ) Ditropan to treat bladder instability.

The other eight drugs either presented new unlabeled safety concerns or "other attributes," including labeled but "serious adverse events of interest" and past safety concerns, the FDA said.

Included in this group are Pfizer's Zyvox, GlaxoSmithKline PLC's (GSK) Zofran and Avandia, Forest Laboratories Inc.'s (FRX) Celexa, Novartis AG's (NVS) Trileptal, Wyeth's (WYE) Rapamune and Abbott Laboratories' (ABT) Norvir.

In an updated report for depression drug Celexa, the FDA staff identified three new cases associated with QT prolongation, which can cause a fatal arrhythmia, since August 2003. The FDA requested the review following a prior report that found a possible association between the drug and the problem in all ages.

"However, this updated review of three new cases didn't find any well-documented cases of QT prolongation associated with using regular doses of (Celexa) in pediatric patients," the FDA staff concluded.

On Pfizer's Zyvox, which is indicated for treatment of certain bacterial infections, the FDA staff found six unlabeled events of "cardiac nature" during the one-year review. The report, however, said the cases "cannot be definitively associated" with the drug.

In the report on epilepsy drug Trileptal, the FDA staff recorded 84 adverse events in children taking the drug in the year-long review. Those events included one death, 52 unlabeled and 31 labeled cases. The staff said the unlabeled cases were too few to "characterize any one adverse event as a potential safety signal."

On Wyeth's Rapamune, the investigation found 19 pediatric cases of adverse events, including two reports of fluid collection that develops between the lining of the heart and the heart itself, and one report of cerebral bleeding.
Rapamune is indicated for the prophylaxis of organ rejection in patients ages 13 or older receiving a renal transplant. The FDA staff, however, said the majority of children it studied were under 12 years of age.

The report found it was "premature" to determine if the drug "played a clear role" in the adverse events reported.
On Glaxo's Zofran, used to prevent nausea and vomiting associated with chemotherapy and radiotherapy for cancer, the FDA staff identified 20 adverse events over a year, including one death. The report said, however, that most patients had underlying conditions or were taking other medication, making it difficult to link the events to the use of Zofran.
In the review of diabetes drug Avandia, the staff found two adverse cases during the one-year period, one involving accidental ingestion and the other involving behavioral changes. It said there were too few reported events to draw any safety conclusion.

On Abbott Labs' Norvir, used to treat HIV patients, the review found 33 adverse events in children in a period of one year, including skin reactions, anemia and pancreatitis. There were three deaths, none directly related to the use of the drug, the FDA said, adding it didn't find any safety concerns.

In the reports, the staff said it will continue to monitor adverse events related to the drugs. The FDA panel will meet at the agency's headquarters in Rockville, Md.

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RADAR Finds Drug Reactions http://www.yourlawyer.com/articles/title/radar-finds-drug-reactions Wed, 04 May 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/radar-finds-drug-reactions
The report in the Journal of the American Medical Association is one of the results of an independent pharmaceutical surveillance program known as RADAR (Research on Adverse Drug Events and Reports Project), which looks at the safety of drugs already on the market.

The scientists from Northwestern University scoured academic journals, reports by pharmaceutical companies, and the U.S. Food and Drug Administration’s database for information about adverse reactions to common drugs.

They identified reactions that affected nearly 1,700 patients, and divided them into three groups of effects: death, severe organ failure, or cases requiring major interventions like CPR or liver transplantation.

The results show that 170 people died from adverse drug reactions. One novel cancer drug alone is associated with 67 deaths.

"RADAR has proved to be a powerful new instrument that supplements existing FDA surveillance systems and has helped save hundreds to thousands of patient lives," said Charles L. Bennett, program director.

The FDA has come under fire recently for not adequately policing the safety of marketed drugs. Several drugs have been withdrawn from the market or re-labeled to warn of additional side-effects.

"It’s the FDA’s responsibility to make sure that the drugs which go on the market are safe and effective," said Elizabeth Boehm, a senior research analyst with Forrester.

New Jersey-based Merck withdrew its COX-2 inhibitor Vioxx on September 30, after studies showed the arthritis drug caused heart problems. Pfizer followed suit on April 7 with Bextra, and Biogen Idec and Elan suspended sales of multiple sclerosis drug Tysabri on February 28.

Suspicion has also been cast over common painkillers such as Advil, Motrin, and Aleve, as well as Scios’ heart drug Natrecor, and Novartis’ epilepsy drug Trileptal.

These have prompted calls for post-market monitoring of drugs by independent groups of scientists, such as those involved in RADAR.

According to Ms. Boehm, some drugs are approved after a very short period of testing on the condition that they are continually monitored while on the market.

"It’s the follow-up on that which is under-resourced. That’s the most politically sensitive way I can put it," she said. "The FDA is not staffed to monitor all of these drugs over the long haul."

Currently, it’s largely up to drug companies to report safety issues once a drug is already for sale. "For good business reasons, they aren’t going out there to seek out every adverse drug event," added Ms. Boehm.]]>
Trileptal (oxcarbazepine) Tablets and Oral Solution http://www.yourlawyer.com/articles/title/trileptal-oxcarbazepine-tablets-and-oral-solution Tue, 19 Apr 2005 00:00:00 -0400 http://www.yourlawyer.com/articles/title/trileptal-oxcarbazepine-tablets-and-oral-solution
The updated warnings section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.]]>
Trileptal Side Effects Lawsuits | Side Effects: Dermatological Reactions, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) http://www.yourlawyer.com/topics/overview/trileptal Tue, 19 Apr 2005 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/trileptal CLICK HERE TO DOWNLOAD OUR TRILEPTAL INFORMATION PACKAGE

Trileptal Side Effects May Result In Stevens-Johnson Syndrome Lawsuits

Trileptal | Lawsuits, Lawyers | Side Effects: Dermatological Reactions, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN)

Trileptal (Generic: Oxcarbazepine) is an antiepileptic drug that has been approved by the U.S. Food and Drug Administration and is indicated for use as monotherapy (by itself) or adjunctive therapy (taken with other medications) in the treatment of partial seizures in adults and children 4 years of age and older with epilepsy.

Novartis Pharmaceuticals and the FDA notified healthcare professionals about revisions to the warnings and precautions sections of the prescribing information for Trileptal tablets and oral suspension. The updated warnings section describes serious dermatological reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), that have been reported in both children and adults in association with Trileptal use. The PRECAUTIONS section has been updated to include language regarding multi-organ hypersensitivity reactions that have been reported in association with Trileptal use.  Trileptal has been available in the United States since February 2000, and has been prescribed for over 250,000 patients. In 2004, sales of Trileptal totaled $391 million.

Legal Help For Victims Affected By Trileptal

If you or a loved one took Trileptal and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).

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