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Posts Tagged ‘Health care provider’

FDA Alert – Drug Safety Communication: Valproate Products – Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)

Posted by 4love2love on July 24, 2011

June 30, 2011
Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics

ISSUE: FDA notified healthcare professionalsthat children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on the results of epidemiologic studies that show that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on cognitive tests (IQ and other tests) than children born to mothers who took other anti-seizure medications during pregnancy. See the Drug Safety Communication for a data summary and additional information.

BACKGROUND: Valproate products are FDA-approved drugs to treat seizures, and manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), and to prevent migraine headaches. They are also used off-label (for unapproved uses) for other conditions, particularly for other psychiatric conditions.

RECOMMENDATION: Healthcare professionals should inform women of childbearing age of the increased risk for adverse effects on cognitive development with prenatal valproate exposure, and should continue to counsel women of childbearing potential taking valproate about the increased risk of major malformations, including neural tube defects, when valproate is used during pregnancy. In addition, healthcare professionals should weigh the benefits and risks of valproate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of adverse birth outcomes should be considered. Patients should not stop taking valproate without talking to a healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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Orlando Sentinel – Mount Dora mom launches campaign about rare condition a year after her son’s death

Posted by 4love2love on June 24, 2011

By Martin E. Comas, Orlando Sentinel10:32 a.m. EDT, June 24, 2011

MOUNT DORA — Vincent Groetzner was a fun-loving 6-year-old who enjoyed soccer and painting when his body temperature suddenly skyrocketed to 108 degrees a year ago. His mother quickly raced him to a hospital emergency room, where he died within minutes.

An autopsy showed that Vincent died of malignant hyperthermia, a rare condition caused by a faulty gene that, in addition to triggering a soaring fever, turns muscles extremely rigid.

Since her son died June 14, 2010, Vincent’s mother, Lisa Groetzner, 44, has launched a campaign to educate medical professionals and the public about malignant hyperthermia and what provokes it. She has spoken to University of Central Florida nursing students, visited hospitals and held seminars with paramedics and other emergency officials across Central Florida.

On Saturday, the Malignant Hyperthermia Association of the United States will hold its annual conference in Mount Dora, largely because of Groetzner’s urging. Dozens of people are expected to attend the one-day event, including medical experts from across the country who are scheduled to make presentations about the condition and how to identify and treat it.

Groetzner, who works for a computer technology firm, had no idea such a condition even existed before her son died in front of her in the emergency room at Florida HospitalWaterman in Tavares.

“When Vincent died, I had to find out what this was and how to make sure that the medical community knows about this and hopefully prevent someone else from dying,” Groetzner said. “Otherwise, I feel it would be a disservice to Vincent.”

She soon delved into the condition — including its causes, treatments and how to identify it — by talking to medical experts and reading any literature she could get her hands on. She had her family genetically tested and discovered that her husband, Paul, her 6-year-old son, Dominic, and her 3-year-old daughter, Avelina, all carry the defective gene.

Malignant hyperthermia most often occurs when a person receives certain types of anesthesia during surgery. Former Orlando Magic forward Derek Strong, for example, almost died from malignant hyperthermia in June 1999 while having surgery to repair a broken nose.

But it also can be triggered by heat exhaustion, caffeine, strenuous exercise or other medical conditions, according to medical experts. If someone with the defective gene were to exercise vigorously outdoors on a hot day and then take in caffeine, such as coffee or some sodas, it could lead to an episode of malignant hyperthermia, said Dr. Andrew Herlich, an anesthesiologist with the University of Pittsburgh Medical Center Mercy.

That’s the message Groetzner hopes to spread among medical professionals.

“They need to know that there are more cases that are not about anesthesia,” she said, pointing out that certainmuscle conditions also can trigger an episode.

Vincent, for example, suffered from a disorder that affects skeletal muscles, which also causes an increased risk of developing malignant hyperthermia. He was playing at a friend’s house when his fever started to rapidly climb on one of the hottest days of the year.

An episode occurs when the patient suffers extreme muscle rigidity, a racing heart and a body temperature that suddenly starts to climb rapidly. If recognized early, a patient is treated with cooling blankets and doses of the drug Dantrolene.

Vincent’s death drew the attention of medical professionals across the U.S. because it did not involve anesthesia, which was long thought to be one of the only causes of malignant hyperthermia when it was discovered in the early 1960s.

Herlich, who is scheduled to speak at Saturday’s event, pointed out that most general practitioners don’t know about malignant hyperthermia because it’s such a rarity.

“All anesthesiologists know about it. Many critical-care workers know about it,” he said. “But the general-care physician is relatively unaware of it. And I don’t mean this in a pejorative way. So when something like this hits the lay press, the awareness jumps. That’s a good thing. But it’s a sad thing that there are individuals who die before there’s more of an awareness.”

That’s why it’s important for medical professionals to ask patients about their family’s health history before surgery to learn whether a person may be susceptible to malignant hyperthermia, association officials said. The association has put up posters about the condition in hospital surgery rooms across the country for medical professionals, staff and patients.

Patients who have had problems with anesthesia or are concerned they may have malignant hyperthermia can be tested by undergoing a muscle biopsy or blood-drawn genetic test.

There are no exact numbers as to how many people have the defective gene that causes malignant hyperthermia. The rate of occurrence has been estimated to be as frequent as one in 5,000 or as rare as one in 65,000 administrations of general anesthesia with triggering agents.

Herlich said he has seen and treated four cases in about 35 years of practicing medicine, all of which were the result of anesthesia. He also works as a consultant for an association hotline that medical professionals and emergency responders can call for information when they believe they are treating a case of malignant hyperthermia.

Michael Wesolowski, a spokesman for the Malignant Hyperthermia Association, said Groetzner’s efforts have significantly increased awareness of the condition, particularly the fact that it can be triggered without anesthesia.

“She’s spreading the message that it’s incumbent upon the medical profession to be prepared,” Wesolowski said.

Framed on a wall at the Groetzner home is Vincent’s soccer jersey, signed by his teammate. Throughout the home are dozens of pictures of Vincent wearing a cheerful smile and tousled hair, along with his artwork.

“We want to get the word out there,” Lisa Groetzner said. “Because we may have other children that might end up in the ER with this. … And I just can’t let another child go through with this. Otherwise, Vincent’s death would have been in vain.”

mcomas@tribune.com or 352-742-5927.

Copyright © 2011, Orlando Sentinel

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