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The Food and Drug Administration says it is re-examining the safety of a medication that was approved despite concerns that not enough was known about the drug's risks.In response to questioning at a budget hearing last week, FDA Commissioner Scott Gottlieb told members of Congress that he would "take another look" at Nuplazid, which is the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis.The medication has been cited as a so-called "suspect" medication in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, as highlighted in a recent CNN report.The FDA told CNN this week that the agency had already begun conducting a new evaluation of the medication when Gottlieb was questioned about it at the hearing. The agency said the review had started several weeks ago."What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, a member and former chair of the congressional subcommittee responsible for funding and overseeing the FDA.DeLauro pressed Gottlieb for answers on his agency's response to the safety concerns surrounding Nuplazid."How many more adverse events do we have to have reported? How many people, quite frankly, have to die? Why does the industry always take precedence over public health and safety?"Tracked by the FDA, the adverse event reports cited by DeLauro do not mean that a suspected medication has been ruled the cause of harm and are typically not the result of official investigations. But the FDA uses the information to monitor potential issues with a drug and can take action as needed: updating a medication's label, for instance, or restricting its use. In rare cases, the agency can even pull a drug off the market.When asked by CNN about what prompted the FDA's new evaluation of Nuplazid, the agency said the decision was based on a number of factors but wouldn't say what those factors were. Instead, it would only comment generally, saying that it identifies "potential signals of serious risk/new safety information" in part by using adverse event data and that the agency is not suggesting physicians stop prescribing the drug or take patients off of it while a safety evaluation is taking place.The FDA has noted that the death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions and often take other medications that can increase the risk of death.But physicians, researchers and other medical experts told CNN that the high number of reports deserved a closer look to determine whether they were related to the drug. They also recommended further testing of Nuplazid, worrying that the drug had been approved too quickly, based on too little evidence that it was safe or effective.Nuplazid's review was expedited by the FDA because it had been designated a "breakthrough therapy," meaning it demonstrated "substantial improvement" in patients with serious or life-threatening diseases compared to treatments already on the market.Dr. Paul Andreason, the physician who led the FDA's medical review of Nuplazid, warned that patients taking the drug during the company's clinical trials experienced serious outcomes, including death, at more than double the rate of those taking the placebo. But the FDA ruled that the potential benefits outweighed the risks, agreeing with an advisory committee that cited a lack of safe alternatives and the pleas from family members who claimed the drug was already helping or could help their loved ones.At that advisory committee meeting two years ago, one woman said that her grandmother had been part of the clinical trials for the drug and that Nuplazid had been life-changing."We didn't know what to expect or even if she was on the drug" or a placebo, said Zoey Wade. "We soon realized that she must be taking the drug, because she really returned to herself. Her hallucinations reduced, and she better understood what was real and what was imaginary."Shortly after Nuplazid's release, however, patients' family members, doctors and other health care professionals started reporting "adverse events" possibly linked to the medication -- including deaths, life-threatening incidents, falls, insomnia, nausea and fatigue.During the first 10 months Nuplazid was on the market, 244 deaths were reported to the FDA in which Nuplazid was a "suspect" medication, according to an analysis conducted by the Institute for Safe Medication Practices. FDA data now show that the number of reported deaths has risen to more than 700. In more than 1,000 reports, patients continued to experience hallucinations while on Nuplazid.After CNN published its investigation on Nuplazid, reporters were contacted by family members who said the drug helped tame hallucinations with few apparent side effects and others who said they believe Nuplazid contributed to their family member's decline or death. Some said they had not yet reported these experiences to the drugmaker or the FDA.While the FDA has long been criticized for being too slow to approve drugs, DeLauro seized on its push to streamline the process, lambasting the agency for putting industry interests and efficiency above public health and safety.DeLauro described the number of adverse events and deaths as "staggering" and "unprecedented." She also expressed concern that the drugmaker, Acadia Pharmaceuticals, is attempting to get the drug approved for a larger population: patients who suffer from dementia-related psychosis."I don't know why it should stay on the market, especially when the FDA has not determined it to be safe and while the number of adverse events continues to soar," she told Gottlieb.In response to the congresswoman's remarks, Acadia told CNN that adverse event data alone are "not a comprehensive and accurate indicator of the safety profile of any drug." In response to CNN's earlier report on the drug, Acadia said there are a number of reasons for the higher volume of death reports, including the fact that the company distributes Nuplazid through a network of specialty pharmacies that puts the company in more frequent contact with both patients and caregivers -- meaning Acadia is more likely to receive reports of death, which it is required to pass along to the FDA.Commissioner Gottlieb told the committee that the FDA is careful about the decisions it makes and that there may be a higher tolerance for risk in situations where there is an unmet medical need, "so long as the patient is properly informed of what those risks are." This echoed what he told CNN's Dr. Sanjay Gupta in an interview earlier this month.The FDA previously told CNN that it was aware of Nuplazid's "complex safety profile" at the time of approval and required the drugmaker to place warnings on its labeling. The agency also said that, though it was continuing to monitor available information about Nuplazid, it had "not identified a specific safety issue" not already reflected on the medication's label.DeLauro's office told CNN that it plans to follow up with the FDA about its inquiry into Nuplazid. 7224

The coronavirus outbreak has put a hold on many things over the last few months, including some elective surgeries.When Nohely Uriostegui and her husband, Jose Pava, found out they were pregnant with a little boy, they were ecstatic. Then, the unfortunate news: their baby had spina bifida."After that, she said we’re going to do a test. You might be eligible for an in-utero surgery," said Uriostegui.That means surgery while the baby is still in the womb, and it had to be performed before 26 weeks of pregnancy. Everything was set up to go in Chicago until a phone call came from her doctor."He said, 'You know what? Based on COVID, everybody here on the team doesn’t feel like it’s an essential type of surgery,’" recalled Uriostegui.The same situation was unfolding for all types of patients around the country. Those hoping surgery could help their chronic pain were told they’d have to endure it for months longer. Organ transplant candidates were forced to wait as well. For Nohely and Jose, a delay meant they might miss their window to help their baby. But then, hope from three states away in Colorado."For this family, the clock was ticking. She had until she was 26 weeks to have fetal intervention, and that was literally five days, four days away. And they had to get from Chicago to here, be evaluated, have surgery set up to be performed, and so, we were able to do that for them," said Colorado Fetal Care Center surgeon Dr. Ken Liechty.The couple decided to travel to Colorado to have the procedure done."I got there on the 4th; my surgery was set for Monday, April 6, which was the exact same date that I was going to get it done in Chicago, and it was one day before I hit the 26-week mark," said Uriostegui."It’s open fetal surgery on the fetus as the actual patient," said Dr. Liechty. "We excise the cyst, we put the spinal cord back into the spinal canal."Doctors then put the muscle back over to seal it, close the skin over it, and then close the uterus. Without the in-utero surgery, Dr. Liechty says 90 percent of babies with spina bifida have a shunt put in to decompress the brain. However, that likely wouldn’t have been the only surgery he would have needed."These shunts fail, they can get infected, they can have all kinds of problems, they average seven surgeries at least for these shunts in their first few years of their life," said Dr. Liechty.In the time of this pandemic, that could mean more waiting as hospital beds begin to fill back up with coronavirus patients."COVID-19 caused a lot of places around the country to reexamine what cases could be done in their facilities, and a number of fetal centers are actually located in adult centers," said Dr. Liechty.Those places are filling up faster than children's hospitals, causing families like Uriostegui and her husband to almost miss opportunities to help their children before they even enter the world."The neurosurgeon over there actually said to us last time, that if you were to look at him, you would have never guessed that he’s born with spina bifida or that we went through this whole journey," said Uriostegui. 3126

The Church of Jesus Christ of Latter-day Saints is embarking on a rebranding effort of sorts.The church, commonly referred to as the Mormons, really wants people to stop using that word. It also wants people to stop using LDS as an abbreviation. From now on, it prefers that people use the church's full name, and when a shortened reference is needed, to just use "the Church" or "Church of Jesus Christ."These preferences are contained in a new style guide that the Church of Jesus Christ of Latter-day Saints released Thursday. It states that while "the term 'Mormon Church' has long been publicly applied to the Church as a nickname, it is not an authorized title, and the Church discourages its use." It also asks that the term "Mormons" not be used in references to members.Also out: the word "Mormonism," which the style guide states is an "inaccurate" word to use to describe the "doctrine, culture and lifestyle unique to The Church of Jesus Christ of Latter-day Saints." But the word Mormon is fine to use in proper names, like the Book of Mormon, or in historical expressions like the Mormon Trail. 1126

The exhibition fight between former heavyweight boxing champion Mike Tyson and Roy Jones Jr. has a new date.According to a press release by Triller, the 8-round showdown was slated for Sept. 12 but has been pushed back to Nov. 28."Changing the date to November 28 will give more people the opportunity to see the biggest comeback in boxing history," Tyson said in the news release. "This temporary inconvenience will last longer than Roy Jones Jr. He better be ready, I'm coming full force."New fights on the undercard were also announced. Badou Jack will face off against Blake McKernan and Viddal Riley will take on Rashad Coulter as they join the previously-announced bout between Youtube star Jake Paul vs. former NBA player Nate Robinson."Given the enormous interest, the holiday weekend will make this historic battle an even bigger viewing event, marking the first live Pay-Per-View event brought to the world by Triller as the first of the "Triller Battles" series," Triller said in the release.The full fight card:MAIN CARDMain EventMike Tyson vs. Roy Jones Jr.8 rounds - HeavyweightFeatured Bout 2Jake Paul v. Nate Robinson6 rounds - 188lbsFeatured Bout 3Badou Jake vs. Blake McKernan8 rounds - 192lbsFeatured Bout 4Vidal Riley vs. Randy Coulter6 rounds - 210lbsUNDERCARDBout 5Jamaine Ortiz v. Jesse Garcia8 rounds - 135lbsBout 6Irvin Gonzalez vs. Edward Vasquez8 rounds - 140lbsBout 7Giuseppe Cusumano vs. Nick Jones8 rounds - HeavyweightThe event is to take place at Dignity Health Sports Park in California and the California State Athletic Commission is sanctioning the bout.The "Frontline Battle" will be available to watch on Pay-Per-View and the social media platform Triller. 1701

The Center for Disease Control (CDC) has issued a reminder to the public to stop washing and reusing condoms.The CDC said in a tweet that this reminder to all sexually-active Americans was sent out "because people do it." 229

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