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The Food and Drug Administration warned pregnant women on Thursday of using some pain and fever medications during the second half of pregnancies.According to the FDA, these nonsteroidal anti-inflammatory drugs can cause rare but serious kidney problems in the unborn baby, which can cause pregnancy-related complications. Nonsteroidal anti-inflammatory drugs include ibuprofen, naproxen, diclofenac, and celecoxib. The FDA added that its warning does not apply to low-dose aspirin.“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” said Patrizia Cavazzoni, M.D., acting director of FDA’s Center for Drug Evaluation and Research. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”The FDA says that warnings on prescription nonsteroidal anti-inflammatory drugs already advise of complications past 30 weeks. The newest guidance calls on health care providers to only prescribe the lowest effective dose for the shortest period possible for women 20 to 30 weeks into their pregnancy.More information on the warning can be found here. 1259

The family of late singer Tom Petty is upset with President Donald Trump for using the hit song "I Won’t Back Down.”The song was played at the president’s re-election rally in Tulsa, Oklahoma, over the weekend.That in turn prompted the late star's estate to issue a cease and desist notice to Trump's campaign on Saturday.Adria, Annakim, Dana and Jane Petty wrote in a letter posted to Twitter that Trump was not authorized to use the song to “further a campaign that leaves too many Americans and common sense behind.”The estate said, "both the late Tom Petty and his family firmly stand against racism and discrimination of any kind."They added that "Tom Petty would never want a song of his used for a campaign of hate. He liked to bring people together."The letter also said, “We believe in America and we believe in democracy. But Donald Trump is not representing the noble ideals of either."The Trump campaign has yet to release a response about the use of the song. 980

The Cruise Lines International Association announced Monday new regulations for cruising in the Americas.The association, which represents major global cruise lines, said cruises could start back up soon "with support and approval of regulators and destinations.""We recognize the devastating impact that this pandemic, and the subsequent suspension of cruise operations, has had on economies throughout the world, including the nearly half a million members of the wider cruise community and small businesses in the Americas who depend on this vibrant industry for their livelihoods," CLIA president, CEO Kelly Craighead said in the press release. "Based on what we are seeing in Europe, and following months of collaboration with leading public health experts, scientists, and governments, we are confident that these measures will provide a pathway for the return of limited sailings from the U.S. before the end of this year."The new rules include everyone being tested for COVID-19 before embarking and mandatory mask-wearing for everyone onboard.Also, everyone must abide by physical distancing. There will be an increase of fresh air through the ventilation system, medical capability with risk-based response plans, and shore excursions must abide by cruise operators' prescribed protocols.The CLIA announced back in August that its ocean-going cruise line members will suspend their U.S. operations until at least Oct. 31. 1439

The chairman of the House Judiciary Committee subpoenaed the Justice Department on Thursday seeking documents related to a trio of recent controversial decisions made by the FBI, including the decision in 2016 to not charge Hillary Clinton after the probe of her email server and the internal recommendation by an FBI office to fire former FBI Deputy Director Andrew McCabe, his office announced.The move by Virginia Republican Bob Goodlatte represents a ratcheting up of his investigation, led jointly with the House Oversight Committee, into the decisions made by the Justice Department and the FBI before the 2016 election -- an investigation that has stoked mistrust of the law enforcement agency and drawn the ire of Democrats on Capitol Hill.In a letter to Deputy Attorney General Rosenstein accompanying the subpoena, Goodlatte wrote, "given the Department's ongoing delays in producing these documents, I am left with no choice but to issue the enclosed subpoena to compel production of these documents."Goodlatte had in recent weeks voiced his frustration at the Justice Department's refusal to comply with his past requests for the documents and hinted at the weighty legal maneuver.The two committees had requested 1.2 million pages of documents from the Justice Department, Goodlatte's office said. There are approximately 30,000 documents thought to be responsive to the committee's request, and agency staff are reviewing the remaining items to ensure they do not contain sensitive information or conflict with ongoing law enforcement actions, according to Justice Department spokesman Ian Prior.Prior said 3,000 documents have been delivered to the House Judiciary Committee so far.The subpoena issued Thursday covers documents related to "charging decisions in the investigation surrounding former Secretary Clinton's private email server in 2016," as well potential abuses of the Foreign Intelligence Surveillance Act and "all documents and communications relied upon by FBI's Office of Professional Responsibility in reaching its decision to recommend the dismissal of former Deputy Director McCabe."In a statement, Prior said, "The Department of Justice and the FBI take the Committee's inquiry seriously and are committed to accommodating its oversight request in a manner consistent with the Department's law enforcement and national security responsibilities."More than two dozen FBI staff have been assisting the Justice Department in producing documents on a rolling basis to the committee's "broad request," Prior said. 2552

The FDA announced on Friday that it has issued an emergency use authorization for a second coronavirus vaccine. Its approval comes just one week after the FDA gave an emergency use authorization for a similar vaccine by Pfizer. That vaccine began distribution earlier this week. Moderna’s vaccine has been hailed as a medical breakthrough. The vaccine has been considered 94.1% effective against the virus. According to Moderna, none of the thousands who were given two shots of the vaccine had severe COVID-19 symptoms. That is compared to 30 patients who were given a placebo who had symptoms.In order to obtain an emergency use authorization, the FDA weighed the vaccine’s benefits against possible side effects. An emergency use authorization is not a full FDA approval, but it allows those outside of a clinical or hospital setting to obtain the vaccine. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” FDA Commissioner Stephen M. Hahn said in a statement. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”According to Moderna, approximately 20 million doses will be delivered to the U.S. government by the end of December 2020. Moderna said it expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.While the vaccine could nearly eliminate the number of hospitalizations and deaths associated with the virus, the shot might result in some symptoms.In an interview with CNN last month, Operation Warp Speed chief scientific adviser Moncef Slaoui said that 10 to 15% of those immunized had noticeable side effects.“Most people will have much less noticeable side effects. That frankly -- in comparison to a 95% protection against an infection that can be deadly or significantly debilitating -- I think is an appropriate balance," he told CNN. 2648

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