Pompeo Says U.S. Prepared To Offer Guaidó ‘Full Range Of Options’ To Oust Maduro

Pompeo Says U.S. Prepared To Offer Guaidó ‘Full Range Of Options’ To Oust Maduro

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U.S. Secretary of State Mike Pompeo, pictured in March, said he plans to tell his Russian counterpart, Foreign Minister Sergey Lavrov, that Moscow must stop meddling in the Venezuelan crisis. Chip Somodevilla/Getty Images hide caption

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Chip Somodevilla/Getty Images

U.S. Secretary of State Mike Pompeo, pictured in March, said he plans to tell his Russian counterpart, Foreign Minister Sergey Lavrov, that Moscow must stop meddling in the Venezuelan crisis.

Chip Somodevilla/Getty Images

Secretary of State Mike Pompeo said on Sunday that the Trump administration is preparing to pull the trigger on a broad range of options to oust Venezuelan President Nicolás Maduro, and demanded that interfering countries end their involvement in the beleaguered nation’s affairs.

In a string of television appearances, Pompeo suggested the fall of Maduro’s government is imminent and that the support for opposition leader Juan Guaidó remains strong despite his failed attempt last week to lead a large-scale defection against the socialist leader.

“We have a full range of options that we’re preparing for,” Pompeo said on ABC’s This Week, adding that potential paths forward include “diplomatic options, political options, options with our allies and then ultimately a set of options that would involve use of U.S. military.”

“We’re preparing those for [Guaidó] so that when the situation arises, we’re not flatfooted,” Pompeo said.

When asked if President Trump believes he can intervene without congressional authorization, Pompeo responded by saying he was “very confident any action we took in Venezuela would be lawful.”

The Secretary of State denied suggestions that the president is out of step with his own advisers on the role Russia is playing in the crisis.

After a Friday phone call with Vladimir Putin, Trump said the Russian president “is not looking at all to get involved in Venezuela other than he’d like to see something positive for Venezuela.”

Trump’s remarks contradicted previous statements by Pompeo and National Security Adviser John Bolton, who on Twitter an hour earlier had accused Russia and Cuba of maneuvering to keep Maduro “clinging to power” by providing the regime with supplemental foreign military forces.

But on Fox News Sunday, Pompeo said Trump has been “very clear” about wanting the Russians to stop meddling in Venezuela. He referenced a tweet from several weeks back in which Trump said the Russians have to get out. “That remains our view,” he said. “We want the Venezuelan people not to have interference from any country, whether it’s China or Russia.”

The U.S. and more than 50 other countries recognize Guaidó as the legitimate interim leader. Earlier this week, Guaidó unsuccessfully called on the country’s military to revolt against Maduro, however, anti-Maduro protests have continued.

Pompeo comments come as he gears up for a face-to-face meeting with Russian Foreign Minister Sergey Lavrov on Monday as part of a multi-day trip to Europe.

After a meeting Sunday with Venezuelan Foreign Minister Jorge Arreaza in Moscow, Lavrov condemned the U.S. for allegedly violating international law in what he said was a campaign to to overthrow Maduro, Reuters reported.

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Certain Prescription Insomnia Medicines: New Boxed Warning – Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

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[Posted 04/30/2019]

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with

  • Lunesta (eszopiclone)
  • Sonata (zaleplon)
  • Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)

than other prescription medicines used for sleep.

BACKGROUND: Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.

RECOMMENDATION: 

If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:

  • Stop taking your insomnia medicine.
  • Contact your health care professional right away if you.

Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:

  • Although rare, the behaviors caused by these medicines have led to serious injuries or death.
  • To discontinue taking these medicines if they experience an episode of complex sleep behavior.

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 
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178

[04/30/2019 – Drug Safety Communication – FDA] 

http://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused

MedWatch Safety Alerts for Human Medical Products

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MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

To find recent safety alerts, select the current year in the menu to the left. Search for specific products using the search field above. To receive notifications automatically via e-mail when new safety information is posted to the MedWatch site, subscribe to the MedWatch E-list. New safety information is also posted via the MedWatch RSS feed and MedWatch Twitter

MedWatch 3500 Forms

Product Name Product Date Issued/Updated

http://www.fda.gov/safety/medical-product-safety-information/medwatch-safety-alerts-human-medical-products

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

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Update [7/27/2018] On July 13th, FDA announced a recall of certain batches of valsartan tablets because of an impurity, a chemical known as N-nitrosodimethylamine (NDMA). Valsartan is a medication commonly used to treat high blood pressure and heart failure.

NDMA has been found to increase the occurrence of cancer in animal studies. These animal studies were done using amounts of NDMA much higher than the impurity levels in recalled valsartan batches. Based on these animal studies, the U.S. Environmental Protection Agency considers NDMA a probable human carcinogen—a chemical that can increase the risk of cancer in humans. NDMA is found in some water supplies and in some foods1. Consuming up to 96 nanograms NDMA/day is considered reasonably safe for human ingestion2. It is estimated that over the course of a person’s lifetime, consuming this amount of NDMA would result in less than one additional case of cancer for every 100,000 people. To put this in context, currently one out of every three people in the US will experience cancer in their lifetime.

The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA’s decision to have these batches recalled.

Patients taking valsartan from a recalled batch should continue taking their current medicine until their doctor or pharmacist provides a replacement or a different treatment option. It is important to know that not all valsartan products contained NDMA, so pharmacists may be able to provide a refill of valsartan medication from batches that that are not affected by the recall, or doctors may prescribe a different medication that treats the same indications.

FDA continues to evaluate the safety of valsartan-containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available. If you are taking a valsartan product, be sure to check to back as the lists may change.

_________________________________

1 From Toxnet: https://toxnet.nlm.nih.gov/

Average Daily Intake: WATER: (assume 3 to 6 ng N-nitrosodimethylamine/l)(1) 6 to 12 ng; direct intake from drinking water is probably much less than 1 ug/day(2). FOOD: (assume <0.1 to=”” 84=”” ug/kg)(4)=””><0.16 to=”” 134=””>
[(1) Kimoto WI et al; Water Res 15: 1099-1106 (1981) (2) USEPA; Ambient Water Quality Criteria Doc: Nitrosamines p.C-14 (1980) EPA 440/5-80-064 (4) IARC; IARC Monographs on the Evaluation of Carcinogenic Risks to Humans 17: 125-76 (1978)]

2 The calculated acceptable intake for NDMA is based on methods described in the ICH Guidance M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
(http://wcms-internet.fda.gov/files/drugs/published/M7-R1-AssessmentAndControlOfDNA-Reactive-Mutagenic-ImpuritiesInPharmaceuticalsToLimitPotentialCarcinogenicRisk-Guidance.pdf)

http://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-angiotensin-ii-receptor-blocker-arb-recalls-valsartan-losartan

More Questions and Answers: Impurities Found in Certain Angiotensin II Receptor Blocker (ARB) products

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We review information on impurity testing provided in drug applications and when inspecting manufacturing facilities.

Manufacturers are required to test for impurities that may be introduced or developed during their manufacturing processes.

We review that information in drug applications, including requests to change the manufacturing process.

We employ organic chemists to review applications and referenced information to look for steps – and manufacturing changes – where these risks could be introduced.

We also inspect manufacturing facilities around the world, and in routine current good manufacturing practices inspections we can review a manufacturer’s records regarding impurity testing.

However, the review of records depends on manufacturers conducting appropriate tests that are capable of detecting the impurity.

Tests are selected based on assessments of what impurities may develop based on the manufacturing process.

In other words, it needs to be recognized that there is a risk of an impurity occurring to know that it should be tested for.

Before we undertook this analysis, neither regulators nor industry fully understood how the nitrosamines could form during the manufacturing process.

http://www.fda.gov/drugs/drug-safety-and-availability/more-questions-and-answers-impurities-found-certain-angiotensin-ii-receptor-blocker-arb-products

Where and How to Dispose of Unused Medicines

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Is your medicine cabinet full of expired drugs or medications you no longer use? Your medicine is for you. What’s safe for you might be harmful for someone else. You can dispose of your expired, unwanted, or unused medicines through a drug take back program — or you can do it at home. 

Drug Take Back Programs

The U.S. Drug Enforcement Administration (DEA) sponsors National Prescription Drug Take Back Day in communities nationwide. Many communities also have their own drug take back programs. Check with your local law enforcement officials to find a location near you or with the DEA to find a DEA-authorized collector in your community.

You can also check with your pharmacist. Some pharmacies have mail-back programs and disposal kiosks for unused medicines.

How to Dispose of Medicines at Home

There are two ways to dispose of medicine, depending on the drug.

Flushing medicines: Because some medicines could be especially harmful to others, they have specific directions to immediately flush them down the sink or toilet when they are no longer needed.

How will you know? Check the label or the patient information leaflet with your medicine. Or consult the U.S. Food and Drug Administration’s list of medicines recommended for disposal by flushing.

Disposing medicines in household trash: Almost all medicines can be thrown into your household trash. These include prescription and over-the-counter (OTC) drugs in pills, liquids, drops, patches, creams, and inhalers.

Follow these steps:

  1. Remove the drugs from their original containers and mix them with something undesirable, such as used coffee grounds, dirt, or cat litter. This makes the medicine less appealing to children and pets and unrecognizable to someone who might intentionally go through the trash looking for drugs.
  2. Put the mixture in something you can close (a re-sealable zipper storage bag, empty can, or other container) to prevent the drug from leaking or spilling out.
  3. Throw the container in the garbage.
  4. Scratch out all your personal information on the empty medicine packaging to protect your identity and privacy. Throw the packaging away.

If you have a question about your medicine, ask your health care provider or pharmacist.

Disposing of Fentanyl Patches

Some prescription drugs — such as powerful narcotic pain medicines and other controlled substances — have instructions for flushing to reduce the danger of overdose from unintentional or illegal use.

One example is the fentanyl patch. This adhesive patch delivers a strong pain medicine through the skin. Even after a patch is used, a lot of the medicine remains. That’s why the drug comes with instructions to flush used or leftover patches.

Disposing of Inhaler Products

One environmental concern involves inhalers used by people who have asthma or other breathing problems, such as chronic obstructive pulmonary disease. Read handling instructions on the labeling of inhalers and aerosol products. These products could be dangerous if punctured or thrown into a fire or incinerator. To properly dispose of these products and follow local regulations and laws, contact your trash and recycling facility.

Flushing Drugs and the Water Supply

Some people wonder if it’s okay to flush certain medicines. There are concerns about the small levels of drugs that may be found in surface water, such as rivers and lakes, and in drinking water supplies.

“The main way drug residues enter water systems is by people taking medicines and then naturally passing them through their bodies,” says Raanan Bloom, Ph.D., an environmental assessment expert at the FDA. “Many drugs are not completely absorbed or metabolized by the body and can enter the environment after passing through wastewater treatment plants.”

The FDA and the U.S. Environmental Protection Agency take the concerns of flushing certain medicines in the environment seriously. Still, there has been no sign of environmental effects caused by flushing recommended drugs.

Updated: October 25, 2017

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http://www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines

Federal Agents Raid Baltimore Mayor Catherine Pugh’s Home, Office And Nonprofit

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Federal agents raided Baltimore Mayor Catherine Pugh’s offices Thursday following investigations into her “self-dealings.” She sold thousands of her children’s books to groups under her influence.

AUDIE CORNISH, HOST:

Federal agents from the FBI and the IRS raided Baltimore mayor Catherine Pugh’s home, office and a nonprofit she is affiliated with. Mayor Pugh is under investigation for hundreds of thousands of dollars in payments she received for her self-published children’s books – called “Healthy Holly” – from private companies under her influence; those books are about nutrition and exercise. Several weeks ago, the mayor announced her leave from office after being hospitalized for pneumonia. She is still on leave, but the entire city council, many city leaders and the Maryland governor are all calling for her resignation.

Emily Sullivan is a city hall reporter from member station WYPR in Baltimore. She joins us for the latest. And Emily, at this point, we haven’t gotten confirmation that the federal raids are indeed connected to the investigation into her dealings with the children’s book.

EMILY SULLIVAN, BYLINE: So we have gotten confirmation from Pugh’s lawyer that records taken from his office are Mayor Pugh’s. That lawyer said that they were served a subpoena as part of a federal investigation. And the IRS confirmed that they, along with the FBI, carried out the early morning activities at Pugh’s house, at offices at city hall and at a nonprofit that Pugh used to lead. How we got here in the first place is, of course, the “Healthy Holly” book scandal. Pugh had struck up a deal with the University of Maryland Medical System to the tune of half a million dollars. Now this afternoon, the UMMS was served with a federal subpoena of its own for documents into an investigation into her business dealings.

CORNISH: Baltimore already had a former mayor who was ousted after fraudulently using gift cards. The police department has seen its own share of scandals. How are people in Baltimore reacting to this latest development?

SULLIVAN: So I spoke with one community leader and social worker, policy analyst Melissa Schober. She said it was distressing that the money funneled to Pugh could have been spent in other ways to help Baltimore. Here’s what she told me.

MELISSA SCHOBER: These are our folks whose mission and interest, ostensibly, is to improve the health and well-being of the roughly 600,000 people who live here. And when they fail to do that and when they act in their own self-interest, they harm the reputation of the city, and they harm people’s lives for years to come.

SULLIVAN: Walking around Baltimore, we also spoke to Justin Kaye (ph), who echoed the sentiments of Schober.

JUSTIN KAYE: By me being a Baltimore City resident, homeowner and taxpayer, I’m not happy with things in general. So I don’t blame her, and I don’t think it’s one person’s job; I think it’s a whole system of things that need to change. So I gave her the benefit of the doubt. I don’t think much is going to change with who the next person is, if the whole system doesn’t change.

SULLIVAN: People are frustrated with everything that’s gone into investigating Pugh. They think the time, money and energy that has gone into this could have served the city in much better ways.

CORNISH: Given all this public pressure, is there any indication that the mayor will resign?

SULLIVAN: So like you said earlier, a huge majority of Maryland elected officials have called on her to resign. Governor Hogan did so this morning, and the entire city council did a few weeks back. Now, Pugh broke her silence after the council’s demand. She said that she’s only out on medical leave, and that she fully intends to come back on the job. She hasn’t commented on today’s activities, and her fill-in, acting Mayor Jack Young, says she hasn’t shared any details about her plans to come back with him. At this point, the length of her leave of absence remains unknown.

CORNISH: That’s Emily Sullivan, city hall reporter for station WYPR in Baltimore. Thanks so much.

SULLIVAN: Thanks, Audie.

(SOUNDBITE OF ABFAHRT HINWIL’S “PLANQUADRAT”)

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June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement

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Center Date Time Location
CDER June 6, 2019 8:30 a.m. to 4:30 p.m.
 
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland 20993

Agenda

The committee will discuss new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB).

Meeting Materials

FDA intends to make background material available to the public no later than two (2) business days before the meeting. If FDA is unable to post the background material on its web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s web site after the meeting. Background material is available at: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee).

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA- 2019-N-1317. The docket will close on June 5, 2019. Submit either electronic or written comments on this public meeting by June 5, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 5, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 5, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before May 22, 2019 will be provided to the Committee. Comments received after that date but by June 5, 2019 will be taken into consideration by FDA. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

  • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
  • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

  • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2019-N-1317 for “Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments, those filed in a timely manner, will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

  • Confidential Submissions–To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Oral presentations from the public will be scheduled between approximately 1:30 p.m. to 2:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 14, 2019.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 15, 2019.

Webcast Information

CDER plans to provide a free of charge, live webcast of the June 6, 2019 AMDAC meeting. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2019 Meeting Materials, Antimicrobial Drugs Advisory Committee (formerly known as the Anti-Infective Drugs Advisory Committee)

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • FDA Advisory Committee Information Line
    1-800-741-8138
    (301-443-0572 in the Washington DC area)
    Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the FDA’s website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301–796–4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner (see CONTACT INFORMATION) at least seven (7) days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

https://www.fda.gov/AdvisoryCommittees/Calendar/ucm636629.htm

La FDA identifica daños reportados por la interrupción repentina de analgésicos opioides y exige cambios a la etiqueta para guiar a los profesionales autorizados a recetar medicamentos en la disminución gradual, individualizada de las dosis

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[4-9-2019] La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de Estados Unidos recibió reportes de daños graves en pacientes que dependen físicamente de analgésicos opioides cuando estos medicamentos se interrumpen de repente o la dosis se reduce rápidamente. Entre ellos se incluyen serios síntomas de abstinencia, dolores incontrolables, angustia psicológica y suicidio.

Mientras continuamos realizando el seguimiento de esta cuestión de seguridad como parte de nuestro monitoreo permanente de los riesgos asociados con los analgésicos opioides, vamos a exigir cambios a la información la de prescripción para estos medicamentos cuyo uso está destinado a un entorno de pacientes ambulatorios. Estos cambios proporcionarán una orientación más amplia a los profesionales autorizados a recetar medicamentos sobre cómo disminuir con en forma segura la dosis en pacientes que dependen físicamente de analgésicos opioides, cuando la dosis debe reducirse o cuando el medicamento debe discontinuarse.

La interrupción repentina puede resultar en dolores incontrolables o en síntomas de abstinencia. A su vez, estos síntomas pueden llevar a los pacientes a buscar fuentes alternas de analgésicos opioides, que pueden confundirse con la búsqueda de fármacos con fines de abuso. Los pacientes pueden intentar tratar su dolor o los síntomas de abstinencia con opioides ilícitos, como la heroína, y otras sustancias.

Los opioides son una clase de potentes medicamentos de venta bajo receta médica que se utilizan para manejar el dolor cuando otros tratamientos y medicamentos no se pueden tomar o no son capaces de proporcionar suficiente alivio para el dolor. Conllevan graves riesgos, incluyendo el abuso, la adicción, la sobredosis y la muerte. Entre los ejemplos de opioides comunes podemos mencionar la codeína, el fentanilo, la hidrocodona, la hidromorfona, la morfina, la oxicodona y la oximorfona.

Los profesionales de atención médica no deben interrumpir abruptamente los opioides en pacientes con dependencia física. Cuando usted o su paciente han acordado reducir la dosis de un analgésico opioide, considere una diversidad de factores, incluidos la dosis del medicamento, la duración del tratamiento, el tipo de dolor tratado y las características físicas y psicológicas del paciente. No existe un régimen estándar de disminución de los opioides que sea adecuado para todos los pacientes. Debe crear un plan específico para el paciente para reducir en forma gradual la dosis del opioide y asegurar el monitoreo y apoyo continuos, según sea necesario, para evitar los síntomas de abstinencia graves, la acentuación de dolor del paciente o la angustia psicológica (Para la reducción gradual y recomendaciones adicionales, consulte Información adicional para los profesionales de atención médica).

Los pacientes que toman analgésicos opioides a lago plazo no deben dejar de tomar el medicamento repentinamente sin primero hablar con su profesional de atención médica sobre un plan para reducir lentamente la dosis del opioide y continuar manejando el dolor. Incluso cuando la dosis del opioide se va reduciendo gradualmente, el paciente puede experimentar síntomas de abstinencia (Consulte Información adicional para pacientes). Contacte a su profesional de atención médica si presenta un aumento del dolor, síntomas de abstinencia, cambios en el estado de ánimo o pensamientos suicidas.

Continuaremos monitoreando esta cuestión de seguridad y publicaremos una actualización para el público cuando contemos con nueva información. Debido a que estamos constantemente monitoreando la seguridad de los analgésicos opioides, también estamos incluyendo nueva información de prescripción sobre otros efectos secundarios que incluyen la apnea central del sueño y las interacciones con los medicamentos. También estamos actualizando la información sobre el almacenamiento y eliminación adecuados de estos medicamentos que actualmente está disponible en nuestra página web en Eliminación de medicamentos no utilizados.

Para ayudar a la FDA a realizar el seguimiento de cuestiones de seguridad con los medicamentos, alentamos a los pacientes y profesionales de atención médica a reportar los efectos secundarios que involucren opioides u otros medicamentos al programa MedWatch de la FDA, usando la información del recuadro que aparece al final de la página donde dice “Comuníquese con la FDA”.

https://www.fda.gov/Drugs/DrugSafety/ucm636211.htm

Officials In Sanctuary Cities Condemn Trump’s Proposal To Move Immigrant Detainees

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The president says he is considering sending detained immigrants in the country illegally to sanctuary cities. San Francisco is among the cities that have passed sanctuary city ordinances.

AUDIE CORNISH, HOST:

Officials in sanctuary cities are largely condemning President Trump’s proposal to move immigrant detainees from the border to those cities. There are almost 200 sanctuary municipalities, states and counties across the U.S. San Francisco is one of them. City leaders there say that although they would welcome migrants, they don’t think transporting them to the city is the best option. Sonja Hutson from member station KQED reports.

SONJA HUTSON, BYLINE: San Francisco’s had a sanctuary policy since 1989. It limits the ability of law enforcement to cooperate with federal immigration authorities. San Francisco Supervisor Sandra Lee Fewer says it’s an ordinance the city is proud of.

SANDRA LEE FEWER: In San Francisco, we don’t know who’s documented and who isn’t. Actually, we just live amongst each other, and we live peacefully.

HUTSON: While Fewer and other officials are denouncing the proposal, they’re also saying they would welcome the migrants if it goes through.

FEWER: We will treat them as human beings. We respect them as people. And we want their families to have a livelihood here, too.

HUTSON: Critics of sanctuary policies say they endanger residents. They point to the fatal 2015 shooting of a woman in San Francisco by an undocumented immigrant. That instance garnered national attention as an example of violence enabled by sanctuary policies. The immigrant, however, was acquitted of murder and manslaughter.

But supporters of the policy, like San Francisco Supervisor Rafael Mandelman, say they keep the city safe and help improve the well-being of immigrants.

RAFAEL MANDELMAN: It’s about immigrant communities being able to go to the police, be able to go to our public health resources. Our city will not be stronger if our immigrant communities feel that they can’t go to the police or can’t go see a doctor.

HUTSON: In addition to several major cities, including San Francisco, Oakland and Los Angeles, the entire state of California has a sanctuary policy. Kevin de Leon authored the sanctuary state law when he represented parts of Los Angeles in the state Senate. He says another concern is the cost of transporting these migrants.

KEVIN DE LEON: Wasting taxpayer dollars to put folks on a plane specifically to sanctuary cities is a non-starter.

HUTSON: San Francisco is more than 500 miles from the California-Mexico border. De Leon says the proposal has little to do with what’s best for immigration and more to do with agitating President Trump’s base in the run-up to the 2020 election.

DE LEON: It’s clearly not done to benefit the immigrants themselves, but rather to do everything within his power to embarrass elected official leaders throughout the state who have defended immigrants.

HUTSON: This isn’t the first time the Trump administration has singled out sanctuary cities. In 2017, it threatened to withhold law enforcement grants from nearly 30 jurisdictions. In the end, many courts determined the federal government could not withhold those grants.

But not everyone in California or San Francisco agrees with the elected leaders who put forth these policies. Harmeet Dhillon is the Republican National Committeewoman for California and a lawyer in San Francisco. She supports President Trump’s proposal to move immigrants to sanctuary cities. And she says the Democratic response to that suggestion has been hypocritical.

HARMEET DHILLON: Talk about political ploys and political pawns. Democrats have been using illegal aliens as political pawns and selling points and talking points for their pandering to the Hispanic vote for decades.

HUTSON: And Dhillon says city officials shouldn’t be welcoming large amounts of undocumented immigrants into places like San Francisco.

DHILLON: Actually, when you can’t take care of the health and welfare needs and educational needs of your own citizens, then you are a bad leader trying to dilute those resources amongst people who have not necessarily paid their dues to be here in this country.

HUTSON: Dhillon says sanctuary cities should focus on helping current residents, including large homeless populations in San Francisco, Oakland and Los Angeles. For NPR News, I’m Sonja Hutson in San Francisco.

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