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The US Food and Drug Administration expanded?the list of drugs being recalled that contain valsartan. The drug is used as a component in a set of drugs used to treat heart failure and blood pressure.New to the list are some valsartan products manufactured by Hetero Labs Ltd. in India, which are labeled as Camber Pharmaceuticals Inc. Test results show that some of the products may be tainted.The FDA announced a valsartan recall in July after lab tests revealed that some drugs could have been tainted with a substance linked to higher risk of cancer. The drug had been recalled in 22 other countries. The expanded recall includes some drugs that contain valsartan and hydrochlorothisazide. Not all of the drugs containing valsartan were affected.N-nitrosodimethylamine or NDMA, the impurity the lab tests found, is considered a?possible carcinogen by the US Environmental Protection Agency. It is an organic chemical that has been used to make liquid rocket fuel, and it can be unintentionally introduced through certain chemical reactions. It's a byproduct of the manufacturing of some pesticides and fish processing.The medicines that are now a part of this expanded list?in the recall are tablets sold by AvKare, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc, Camber Pharmaceuticals, Inc. H J Harkins Company, Northwind Pharmaceuticals, NuCare Pharmaceuticals Inc., Prinston Pharmaceutical Inc. (labeled as Solco Healthcare LLC), Proficient Rx LP, Remedy Repack, Teva Pharmaceuticals (labeled as Major Pharmaceuticals), Teva Pharmaceuticals USA (labeled as Actavis).The FDA also published a list of valsartan products that are not currently recalled. Only the drugs suspected of being tainted with NDMA are on the recall list. If you are taking a valsartan drug, look for the company name on your prescription bottle. If the information isn't on the label, you can call your pharmacy for those details.The recalled medicine is linked to a manufacturer in China. The substances were supplied by Zhejiang Huahai Pharmaceuticals, based in Linhai, in eastern China, which said it notified authorities as soon as it identified the impurity."We published our recall notice at midday on July 13 in China and overseas, and published the US market recall notice on July 14 Beijing time ... all the drug materials for the Chinese market were recalled by July 23," the company said in a statement to the Shanghai stock exchange last month.The FDA said on its website that it's working with drug manufacturers "to ensure future valsartan active pharmaceutical ingredients are not at risk."If you are worried that your drug could be on the recall list, talk with your doctor or pharmacist before changing any routine with your medicine. Because not all valsartan drugs are involved in the recall, they might be able to switch you to a version of the drug made by another company.If you know your drug is on the recall list, the FDA suggests you continue taking it until your doctor or pharmacist provides a replacement.To get a sense of what taking a tainted drug could mean, FDA scientists estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) from the recalled batches every day for four years, there may be one additional case of cancer."The key with this is, patients should not stop taking their medication abruptly, that definitely can be harmful," Dr. Mary Ann Bauman, a representative for the American Heart Association, said in July. "You don't want to jump to any conclusions on your own about this medication, or any medication for that matter. Definitely talk with your doctor first." 3690
The Supreme Court decided on Monday that they will not reexamine a doctrine that protects law enforcement and government officials from being sued over their actions while on the job.The doctrine, which the justices created nearly 50 years ago, gives "qualified immunity" for law enforcement officers, which protects them from frivolous lawsuits CNN reported.The decision comes amid protests over the death of George Floyd, who died while in police custody in Minneapolis.According to CBS News, the courts were to hear one case about a man in Tennessee that was bitten by a police dog, although he was sitting on the ground with his hands raised.NPR reports that two justices, Sonia Sotomayor and Clarence Thomas, have both been skeptical of the doctrine. 763
The White House, after a day of uncertainty, confirmed Wednesday that deputy national security adviser Mira Ricardel is leaving her position.She will remain in the administration.In a statement, press secretary Sarah Sanders said, "Mira Ricardel will continue to support the President as she departs the White House to transition to a new role within the Administration. The President is grateful for Ms. Ricardel's continued service to the American people and her steadfast pursuit of his national security priorities."Sources said the President told advisers Tuesday that he had decided to fire her.The decision comes a day after first lady Melania Trump's office issued a surprising statement calling for Ricardel to leave the White House. 750
The Trump administration will end the protected immigration status of thousands of Central Americans who have been living in the US nearly two decades, urging Congress to act if it wants to spare those individuals from being uprooted.Department of Homeland Security acting Secretary Elaine Duke has decided to terminate Temporary Protected Status for Nicaragua with a 12-month delay, the department announced Monday night. DHS also said Duke has not been able to reach a decision on Honduras despite different agencies' input, triggering an automatic six-month extension. At the end of that six-month window, the homeland security secretary will make a decision to terminate or further extend the status.The Trump administration has signaled a desire to wind down the protections of Temporary Protected Status, which is an immigration status allowed by law for certain countries experiencing dire conditions, such as a natural disaster, epidemic or war. TPS protects individuals from deportation and authorizes them to work in the US. Without TPS, those individuals revert to whatever status they had previously -- which could leave large numbers as undocumented immigrants.In encouraging Congress to act if it wants to extend those protections permanently, the Trump administration echoed its move in ending the popular Deferred Action for Childhood Arrivals program, which protects hundreds of thousands of young undocumented immigrants brought to the US as children and which President Donald Trump decided to sunset this fall.Both decisions were due by Monday, as the status was set to expire January 5. There is a 60-days-in-advance requirement by law to make a determination on extending or terminating Temporary Protected Status.The roughly 5,300 individuals from Nicaragua affected by this decision have lived in the US roughly 20 years: To qualify for TPS, Nicaraguans must have been living in the US continuously since January 5, 1999, after Hurricane Mitch devastated the country.DHS officials told reporters that Duke did not yet have enough information to make a decision on the 86,000 individuals covered under the Honduran protections, which by law triggers a six-month extension. Hondurans also have to have been living in the US continuously since January 5, 1999 to qualify, also due to Hurricane Mitch.The move was being closely watched and heavily lobbied on both sides.Though the administration says it is evaluating each country on its own, it has been more aggressive than previous administrations in evaluating only whether conditions have improved from what triggered the initial designation, regardless of dire conditions continuing due to other causes. That has the support of conservatives like Senate Judiciary Chairman Chuck Grassley, who wrote DHS last week urging them to not perpetually renew TPS.In the next few months, the status of hundreds of thousands of TPS recipients will be up for decision. The Trump administration has already terminated the status for Sudan, extended protections for South Sudan, and given itself an extra six months to decide on protections for roughly 58,000 Haitians. That will be the next decision due, at the end of the month. When former Homeland Security Secretary John Kelly extended Haitian TPS another six months over the summer, he encouraged recipients to either apply for status under some other means or prepare to depart the US.In extending Nicaraguan protections for a final 12 months, DHS officials on a call with reporters urged those recipients to "seek an alternative lawful immigration status in the United States, if eligible, or, if necessary, arrange for their departure."Coming up early next year is also a decision for El Salvador, with roughly 260,000 people covered from that country, who have lived in the US more than 15 years.One official also called on Congress to act if they want individuals to remain permanently. Democrats have heavily lobbied DHS to preserve the protections, as have advocacy groups and business groups like the US Chamber of Commerce."Only Congress can legislate a permanent solution and provide those in an otherwise perpetually temporary status with a certain future," the official said.Democrats were quick to call out the administration's move. The Congressional Hispanic Caucus called on Congress to act following the administration's "reckless" action."The Trump administration's irresponsible decision to end TPS for Nicaraguans will tear apart families and upend the lives of these hard-working individuals," CHC Chairwoman Michelle Lujan Grisham said in a statement. "These immigrants have lived in the United States for nearly 20 years and have raised US citizen children, contributed to our economy and enriched our communities. Deporting families who are contributing to the economic and social fabric of our nation isn't leadership; it's a reckless and callous abuse of power." 4920
The toy run in December is usually one of the big ways Children's Hospital Colorado gets donated toys. But because of COVID-19, the supply of toys is down considerably. So the hospital reached out to some riders, and Sunday, they got a special delivery to help replenish that supply.Kids at Children's Hospital know when they hear those Harley engines roar, toys are on the way."Any motorcycles coming up to the hospital, the kids plaster themselves the windows. They love to see the bikes riding up," volunteer Bob Cuculich said."That's why we do it. It's things like this that make it all worthwhile," organizer Eddie Dane said.But it's not December when this toy run usually happens."Because of COVID this year, the hospital reached out to Rocky Mountain Harley Davidson, because we're a sponsor to the toy run and have been for years," Dane said.Dozens of bikers answered the last minute call to help."They're not reusing toys. So we are are going to replenish their supply and do the best we can to get them some more toys to last them until December," Dane said.They didn't know how many bikers would show. They just knew they needed to try to help the kids."There's a huge need," Cuculich said.But the roars were there, filling up the bins, and they hope more toys can be brought. Just no stuffed animals right now."Plush toys right now, they are just too hard to keep clean, and infection control just makes it a challenge to be able to give those to the kids," Cuculich added.The bikers hope this special delivery makes the kids happy and lasts until the main ride in December. Just a little Christmas in July.KMGH's Sean Towle first reported this story. 1671