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F.D.A. Approves Xywav, a GHB drug, for Uncommon Sleeping Dysfunction

On the black market, homemade GHB — also known as liquid ecstasy, goop and G — can be bought by the capful for $5 to $25. But nightly treatments of Xyrem and Xywav cost roughly $100,000 a year. The new approval will make it much easier for hypersomnia patients to get insurance coverage for Xywav.

Many doctors and patients have never heard of idiopathic hypersomnia, Mr. Cozadd said, but Jazz will aim to change that. “There’s an educational effort that we’ll be part of,” he said, “which is really making sure there’s a better understanding among treaters and among patients of the condition and its treatment.”

The F.D.A. said its decision was significant because it is the first drug approved to treat the disorder.

“Idiopathic hypersomnia is a lifelong condition, and the approval of Xywav will be instrumental in providing treatment for symptoms such as excessive sleepiness and difficulty waking, and in effectively managing this debilitating disorder,” said Dr. Eric Bastings, deputy director of the agency’s Office of Neuroscience, in a statement.

In March, Jazz and the Hypersomnia Foundation, a patient advocacy group, began an awareness campaign — “I have IH” — which included an online survey of health care providers’ knowledge of the condition (it was low), and advertisements in Times Square.

“I never thought I’d live to see that day — it was very emotional,” said Betsy Ashcraft, the treasurer of the foundation’s board of directors, whose adult son has idiopathic hypersomnia. (Jazz paid the foundation for board members’ time consulting on the campaign, she said.)

GHB is an old drug, first synthesized by a Russian chemist in 1874. A century later, it was sold as a dietary supplement in the United States, and academic researchers began reporting that it greatly improved the nighttime sleep of people with narcolepsy and curbed their daytime attacks of paralysis, called cataplexy.

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The Challenges of Bipolar Dysfunction in Younger Individuals

Dr. Birmaher noted that young people with bipolar disorder usually have recurring episodes of major depression, but that “depressive episodes are not necessary for making the diagnosis.” For some, mania is the primary symptom.

When depression is the symptom that brings patients to professional attention, the correct diagnosis can be especially tricky. As Dr. Ketter explained, depressed individuals may be unable to recall previous episodes of mania that occurred when they were not depressed.

Dr. Miklowitz said one of the first signs of bipolar disorder is “mood dysregulation — the child is angry or depressed one moment, then is excited and happy and full of ideas moments later.”

He listed characteristics of mania that can help parents distinguish them from normal teenage highs and lows. The symptoms, several of which should be noticeable to other people, can include “grandiose thinking, decreased need for sleep, rapid or pressured speech and/or flight of ideas, racing thoughts, distractibility, excessive goal-driven activity, and impulsive or reckless behavior,” Dr. Miklowitz said.

With depressive symptoms, he suggests looking for “an impairment in functioning — suddenly not going to school or going late, not finishing homework, sleeping through classes, a drop in grades, not wanting to eat with anyone else, talking about suicide, self-cutting.”

Depending on the severity of a child’s impairment, if nonlife-threatening symptoms are caught in the early teens, Dr. Miklowitz said it may be possible to start with psychotherapy and avoid medication, which has side effects. “But if the child’s life is at risk, if he can’t function at home or at school, medication may be the answer,” he said. “There are risks to not medicating.”

When medication is necessary, he said, the dosage should be just high enough to control symptoms and not be overly sedating.

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C.D.C Confirms Extra Instances of Uncommon Blood Clot Dysfunction Linked to J.&J. Vaccine

Federal health officials have now confirmed 28 cases, including six in men, of a rare bleeding disorder in adults who have received the Johnson & Johnson Covid-19 vaccine.

Dr. Tom Shimabukuro, deputy director of the vaccination safety bureau at the Centers for Disease Control and Prevention, presented the new cases on Wednesday at a CDC advisory board meeting

The number is an increase from the 15 confirmed cases that were all women reported at the meeting last month.

Although officials have now identified a handful of cases in men, women – particularly between the ages of 30 and 49 – appear to be at increased risk. “The trend is that women in all age groups have higher reporting rates than men,” said Dr. Shimabukuro at the meeting.

Patients with the rare but serious disorder develop blood clots, often in the brain, as well as low levels of platelets, components of the blood that promote clotting. The disorder is a “rare, clinically serious, and potentially life-threatening condition,” said Dr. Shimabukuro.

Last month, after reports first emerged that six women who had received the vaccine had developed the disorder, federal health officials recommended discontinuing use of the vaccine during the investigation. They lifted the suspension 10 days later and warned the vaccine label of possible risks that suggest that there is a “plausible” link between the vaccine and the disease.

22 of the confirmed cases so far involved women and six men. All were adults between the ages of 18 and 59 who received the vaccine before the national break. (Another case was also recorded in a 25-year-old male who participated in the clinical trial.)

Three people have died and four remain in the hospital, including one in intensive care. No new deaths have been documented since last month’s meeting, said Dr. Shimabukuro.

The overall risk remains extremely low. More than 9 million doses of the Johnson & Johnson vaccine have now been administered in the United States.

There were 12.4 cases per million doses in women between 30 and 39 years of age and 9.4 cases per million doses in women between 40 and 49 years of age, the two demographics that appear to be at greatest risk. There were fewer than 3 cases per million doses in older women and men of all ages.

Of the 28 confirmed cases, 12 people who developed the disorder had obesity, 7 had high blood pressure, 3 had diabetes, and 3 were taking estrogen, although it is not yet clear whether any of these factors could significantly increase the risk of the disorder.

Officials will continue to look for cases of the coagulation disorder in vaccinated people, said Dr. Shimabukuro.

There were no confirmed cases of coagulation disorder after the Pfizer BioNTech or Moderna vaccines, which use a different technology, said Dr. Shimabukuro.

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‘Busy Inside,’ a New Documentary, Explores Dissociative Identification Dysfunction

For those with the disorder, when an alternate identity takes over, the person may lose track of time and have no memory of what the other personality did while “out”. Ms. Marshall said a woman who treated her had an alternate personality who was a shoplifter and when she returned to her main identity, she had no idea how she acquired all of the things in her apartment.

Dissociative identity disorder is both underdiagnosed and often misdiagnosed as depression or anxiety disorder and consequently abused, said Dr. Mirror. Once affected people realize they have a problem, it takes an average of six years to learn what is causing their symptoms when they should seek help, said Dr. Mirror.

Some people with this disorder never do and somehow manage to lead normal lives until something very stressful causes their alternate identities to take over and disrupt their functioning. For example, Ms. Marshall told me that one person in the film performed well as a company director for many years until a family trauma annoyed them so much that their identities split, very hostile and disabling personalities emerged, and she was no longer able to do her job.

Dr. Spiegel said some people with the disorder “are afraid of or ambivalent about treatment; They do not believe that I am here to help them because, based on their history, they see helpers as potentially harmful. “

At the same time, alternative identities can also arise, as if the person were two people facing each other. The identities develop special roles that emerge under certain circumstances, said Dr. Mirror. For example, one identity can “protect” from another that can be aggressive or harmful. The protective identity might think, “I’ll stay outside while this is so,” he said. As Ms. Marshall explained, people can have one or two identities that act as gatekeepers and keep the others inside.

During treatment, by identifying and highlighting the person’s core values ​​and beliefs, the adult person’s identity that enables them to function normally can learn to adopt identities that are distressing or troubling, Ms. Marshall said.

Her approach to treatment doesn’t necessarily seek to rid people of their alternate identities unless of course they want to. Rather, she said they could learn to use their alternatives constructively so that as adults they could lead normal lives in society.

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A Few Covid Vaccine Recipients Developed a Uncommon Blood Dysfunction

On January 29th, Dr. Bussel Mrs. Legaspis doctor, Dr. Niriksha Chandrani, an email labeled “My Strong Recommendations,” stated that he was “very afraid” that Ms. Legaspi would have a cerebral haemorrhage and recommended a different course of treatment. Dr. Chandrani, chief oncology physician at Elmhurst, realized that Dr. Bussel was a leading authority on platelet disorder, and she took his advice.

She had spent several sleepless nights worrying about Ms. Legaspi.

“I didn’t want her to die,” said Dr. Chandrani.

Recognition…about Luz Legaspi

A day later, Ms. Legaspi’s platelet count had reached 6,000: “Slow but steady progress,” said Dr. Bussel. The next morning it was 40,000, which got them out of the most perilous zone. Two days later, on February 1, there were 71,000.

It’s impossible to tell if the new treatments worked, if the first started, or if she recovered on its own. But on February 2, she went home from the hospital to the Queens apartment she shares with her daughter and 7-year-old grandson. On February 4, her daughter said Ms. Legaspi’s platelet count was 293,000.

Another vaccine recipient, Sarah C., 48, a teacher in Arlington, Texas, received the Moderna vaccine on January 3rd. She asked not to use her full name to protect her privacy.

Two weeks later, she began to have profuse vaginal bleeding. After two days, she saw her obstetrician, who ordered blood tests and other tests. A few hours later he called and urged her to go straight to the emergency room. He was stunned, hoping it was a lab mistake, but her blood count showed no platelets. She had had an exam less than a week before the vaccination and blood test results were completely normal.