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Recall: Erectile Dysfunction, Depression Drugs Mixed Up


Dec. 10, 2020 — Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKare because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company.

Sildenafil is the active ingredient in Viagra, used to treat erectile dysfunction, and trazodone is used to treat major depression.

The recall is for 100 milligram (mg) sildenafil tablets, lot 36884 with an expiration date of 03/2022, and 100 mg trazodone tablets, lot 36783 with an expiration date of 06/2022, CNN reported.

Consuming sildenafil unintentionally may lead to serious health risks for people with underlying medical issues, the FDA said. The drug interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. People with diabetes, high blood pressure, or heart disease often take nitrates.

Meanwhile, taking trazodone by mistake may cause sedation, dizziness, constipation, and blurred vision, the FDA said.

Avkare said it doesn’t know of any patients being harmed by the recalled products, CNN reported.

For more information about the recall, consumers can contact AvKARE at 1-855-361-3993.



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The 7 Most Common Side Effects of Pfizer’s COVID-19 Vaccine According to FDA | The State

The world is in a moment of hope after the first doses of the coronavirus vaccine were applied in the world. After nine months of the pandemic, the United Kingdom became the first country to start its vaccination campaign against SARS-CoV-2, and Pfizer the first pharmaceutical company to have a drug that prevents disease.

The drug was submitted for approval by the US Food and Drug Administration (FDA), which has published a report on its analysis of safety data. According to the FDA document, there are seven most common side effects of Pfizer’s vaccine against COVID-19:

  1. Reactions at the site of injection (84.1 percent).
  2. Fatigue (62.9 percent).
  3. Pain head (55.1 percent).
  4. Pain muscular (38.3 percent).
  5. Shaking chills (31.9 percent).
  6. Pain articulate (23.6 percent).
  7. Fever (14.2 percent).

Serious adverse reactions were more frequent after the second dose and occurred in less than 0.5 percent of cases.. The FDA analyzed safety data from approximately 38,000 participants over 16 years of age who randomly received the vaccine developed by Pfizer and BioNTech, and who were monitored two months after the second dose was administered.

These results “suggest a favorable security profile, with no specific security issues identified that prevent the issuance of an authorization for emergency use“Says the FDA document titled” FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine. “

In addition, the institution points out that this vaccine against COVID-19 can be effective in preventing disease in people over 16 years of age and that its benefits outweigh the risks known or potential.


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FDA: Pfizer COVID Vaccine Effective After One Dose


TUESDAY, Dec. 8, 2020 (HealthDay News) — New data released Tuesday by the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee suggest that Pfizer’s two-dose COVID-19 vaccine works well protecting recipients against COVID-19.

The committee is scheduled to meet on Thursday to consider the Pfizer/BioNTech COVID-19 vaccine for emergency use authorization, CNBC reported.

According to the FDA, the data from Pfizer’s COVID-19 vaccine trials were “consistent” with the agency’s recommendations for an emergency use authorization. The data show that the vaccine provides protection after the first dose and that two doses are “highly effective” in preventing COVID-19.

“As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA,” the agency said.

Today, the United Kingdom began inoculating its citizens with the Pfizer/BioNTech vaccine. The United States is expected to decide on the emergency approval of the vaccine before the end of the week, CNBC reported.



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Dole recalls romaine lettuce in 15 states for possible E. coli contamination. | The State


The E. coli bacteria can cause diarrhea, stomach cramps, and vomiting.

Photo:
Justin Sullivan / Getty Images

Dole Fresh Vegetables is voluntarily withdrawing two of its products in 15 states due to possible contamination by bacteria E.coli.

The Food and Drug Administration of the United States (FDA), reported that the packages of organic romaine hearts that were recalled are Dole Organic Romaine Hearts(UPC 0-71430-90061-1) and Wild Harvest Organic Romaine Hearts (UPC 7-11535-50201-2) that have a harvest date of October 23 and 26.

The withdrawal of the Romaine lettuce affected the products that were distributed in the states of Arizona, Hawaii, Illinois, Indiana, Iowa, Kansas, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, North Carolina, North Dakota Y Virginia.

Dole is the second company in two weeks to voluntarily recall part of its romaine lettuce before the Thanksgiving Day for fear of E. coli contamination. More than a week ago Tanimura & Antle it also recalled packages with this vegetable.

Until this thursday the FDA has not reported any sick person related to the products. The agency mentioned that the lettuces were harvested and packed more than four weeks ago, so the packaging they should no longer be in stores.

The symptoms that a person has when eating food contaminated by the bacteria E. coli they can cause nausea, fatigue, abdominal cramps, diarrhea and in some people kidney failure according to information from the Mayo Clinic.

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FDA approves first coronavirus home test that does not have to be sent to the laboratory | The State



Regulators of the United States Food and Drug Administration (FDA) passed a home test that is capable of detecting coronavirus in 30 minutes, but the exam must be approved by prescription.

Lucira Health’s diagnostic kit allows users to insert a swab into the nose that is then dipped into a laboratory solution that connects to a portable device, which, similar to pregnancy tests, marks the negative and positive result.

Requires a prescription

However, the FDA approved the test Tuesday for emergencies and not for everyone who wants to get one. The exam will require a prescription to limit its use in the initial phase.

So far, the FDA has authorized about 300 tests to detect coronavirus. Most of these involve the participation of a health professional and the sample has to be processed in laboratories with high-tech equipment.

Although there are tests that allow people to collect the sample at home through a runny nose or saliva, the material must be sent to a laboratory for the result, a process that could take several days.

Indeed, the Lucira Health home test would break this pattern.

Part of the advantages of these types of exams is that they prevent people from having to leave their homes; this reduces time and risks of contagion.

“This new testing option is an important diagnostic advancement in addressing the pandemic and reducing the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn said in a news release.

“Today’s action highlights the FDA’s continued commitment to expanding access to COVID-19 testing,” the official said.

Additionally, rapid tests promote immediate quarantine, which in turn implies a lower level of spread of the virus.

A bigger challenge

The challenge for health authorities is that users of these tests report the results.

If the results are not reported back, it will be difficult to know what is happening in the community in general, according to experts on the subject.

The FDA added that the Lucira test may also be performed in doctors’ offices and testing centers. At the moment, the spaces in the US that perform the tests must report the results to state and federal authorities. Doctors are required to report the results of home tests.

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Remdesivir Gets FDA Approval as First Coronavirus Treatment in the US | The NY Journal


Medical personnel show a vial containing the antiviral Remdesivir in a hospital in Essen, Germany.

Photo:
SASCHA STEINBACH / EFE

NEW YORK – The United States Food and Drug Administration (FDA) granted final approval on Thursday as the first treatment against COVID-19 to the antiviral Remdesivir, to date the only one with authorization from the regulator to treat the disease.

In May the antiviral of Gilead Sciences received emergency authorization, a formula to allow use during the pandemic of the treatment still in its experimental stage, and now the FDA granted final approval for cases of COVID-19 patients hospitalized.

Remdesivir has allowed shorter recovery periods in some severe cases of coronavirus, although the World Health Organization (WHO) recently considered, after analyzing provisional data, that the antiviral, as well as others that have been administered to COVID-19 patients, has an almost negligible impact on reducing mortality.

Fauci endorses the antiviral

America’s leading epidemiologist, Dr. Anthony Fauci, has defended the use of Remdesivir, which is being administered to patients in the United States and with which President Donald Trump was treated during his convalescence at the beginning of the month.

With the authorization received, Remdesivir becomes the only treatment authorized in the United States for COVID-19, which has infected more than 41 million people around the world, although there are others that already have emergency authorization such as the use of plasma.

“It is incredible that in less than a year since the first reports of infected by the disease known as COVID-19 in the United States, we have a treatment that is available to all patients who need it,” said the CEO of Gilead, Daniel O’Day.

The pharmaceutical company expects to manufacture more than two million doses of the treatment this year, which is administered intravenously, and multiply that production capacity during 2021.

To do this, the company, which specializes in cancer or HIV treatments, has a network of suppliers and manufacturers around the world.

At the beginning of his treatment for coronavirus, President Donald Trump received intravenous doses of the drug, according to his medical team.

“Last night she received her first dose of intravenous Remdesivir. Our plan is to continue with a five-day treatment of remdesivir, ”Dr. Brian Garibaldi, one of the doctors on the team who treated Trump at the Walter Reed National Military Medical Center, told the media on October 4. .

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FDA Warns of Painkiller Risk During Pregnancy



By Robert Preidt

HealthDay Reporter

FRIDAY, Oct. 16, 2020 (HealthDay News) — If you’re pregnant and you think popping nonsteroidal anti-inflammatory drugs (NSAIDs) for your aches and pains is safe, think again.

The U.S. Food and Drug Administration warned on Thursday that taking these widely used painkillers — which include Advil, Motrin, Aleve and Celebrex — at 20 weeks or later in a pregnancy could raise the risk of complications.

Specifically, taking the medications can cause rare but serious kidney problems in the unborn baby that can lead to low levels of amniotic fluid, increasing the potential for pregnancy complications.

After about 20 weeks of pregnancy, the fetus’s kidneys begin producing most of the amniotic fluid, so kidney problems can cause low levels of this protective fluid. Low levels of amniotic fluid usually resolve if a pregnant woman stops taking an NSAID, according to the FDA.

The agency said it has ordered that NSAID labeling warns women and their health care providers about this risk.

NSAIDs are prescription and over-the-counter (OTC) drugs that include ibuprofen, naproxen, diclofenac and celecoxib, which are taken to treat pain and fever. Aspirin is also an NSAID, but the new labeling rules don’t apply to the use of 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,” Dr. Patrizia Cavazzoni, acting director of FDA’s Center for Drug Evaluation and Research, said in an agency news release.

One ob-gyn noted that over-the-counter NSAIDs may pose the greatest danger to pregnant women.

“Many female patients use ibuprofen regularly for headaches and menstrual cramps,” said Dr. Jennifer Wu, from Lenox Hill Hospital in New York City. “It is very important that these patients realize that ibuprofen and other NSAIDs pose a unique danger to pregnant patients.

“The majority of patients get these medications over the counter and may even be using them at the prescription-strength level,” Wu added. “While many prescription drugs come with the oversight of the pharmacist and a warning label, the over-the-counter medications lack all this. Patients also often assume that over-the-counter necessarily means safe.”


Continued

The FDA’s warning comes after a review of medical literature and cases reported to the agency about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy.

For prescription NSAIDs, the new FDA warning recommends limiting use between about 20 weeks to 30 weeks of pregnancy. A warning to avoid taking NSAIDs after about 30 weeks of pregnancy was already included in prescribing information due to a risk of heart problems in unborn babies.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest possible dose and shortest possible length of time, the FDA said.

Makers of OTC NSAIDs intended for adults will also make similar updates to their labeling, according to the agency.



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Pfizer May Have Its Coronavirus Vaccine Ready In November, But It Will Not Arrive Before Elections | The NY Journal



On several occasions, President Donald Trump has said that a vaccine to curb COVID-19 would be approved for use before November 3.

Pfizer Pharmaceutical hopes to apply in November for emergency authorization for the vaccine it is developing against the coronavirus, but It will not be before the presidential elections on November 3, as promised Donald trump.

As reported this Friday by the executive director of the company, Albert Bourla, Pfizer just in the third week of November will apply to obtain emergency authorization from the Food and Drug Administration (FDA).

Bourla said in a statement that although the pharmaceutical company will know by the end of October if the vaccine works, they will need additional time to collect safety and manufacturing data, which will extend the schedule at least until the last weeks of November.

[La falta de pruebas pone en duda el uso de la vacuna del coronavirus en niños durante los primeros meses]

The announcement marks a departure from previous statements provided by Pfizer, which emphasized that the vaccine could be ready in October, before the election.

That fulfilled the wish of Trump, who repeatedly claimed that a vaccine to curb COVID-19 would be approved for use by November 3.

[Fact check: Trump dice que la vacuna del COVID-19 estará lista en octubre. Pero esto es improbable]

Emergency authorization is a power that the FDA has to approve the use of a drug in a more agile and rapid resolution process, avoiding weeks or months of analysis of the studies presented by a pharmaceutical company.

The FDA will tighten the requirements to approve an emergency vaccine against COVID-19, in an attempt to show transparency and build trust in the public, according to The Washington Post.

To get to request that authorization, Pfizer still has to wait for the results of its vaccine to be positive.

Other pharmaceutical companies seeking the coronavirus vaccine have faced difficulties.

At the beginning of September, the AstraZeneca laboratory suspended its tests in volunteers of the vaccine that it develops together with the University of Oxford in the United Kingdom, after the appearance of “a potentially unexplained disease” in one of the volunteers.

[El mundo ha gastado 21,000 millones de dólares en el desarrollo de la vacuna]

And this week, Johnson & Johnson announced that it will suspend clinical trials of its vaccine due to adverse reactions in volunteers who received the doses. The pharmacy did not say what the disease affects them.

Infectious disease expert Anthony Fauci said that the interruption of the trials is an “unfortunate” fact, although he clarified that it is something that can happen frequently in view of the precautions for the safety of the patients.

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White House Blocks New Health Regulations That Would Delay Vaccine Beyond Elections | The NY Journal


Trump has insisted that there will be a vaccine in late October or early November, something that has alarmed scientists

FDA anticipates that an external expert committee can oversee compliance with the new guidelines.

Photo:
THIBAULT SAVARY / AFP / Getty Images

Senior officials in the White House are blocking new federal guidelines on the emergency release of a vaccine against coronavirus. The Government’s argument is that, if applied, the authorization of said vaccine would be delayed beyond the elections of November 3, as published The New York Times.

Faced with the White House lockdown, the Food and Drug Administration (FDA) is looking for other ways to ensure that vaccines meet criteria.

One of the alternative options that FDA is considering is to share the standards with a external expert committee that meets publicly before any vaccine is approved for emergency use. This meeting could take place this week, according to the publication of the New York newspaper.

The hope is that the committee will monitor compliance with the guidelines, despite the reaction from the White House.

This fight over vaccine guidelines is part of a war between the government and federal agencies charged with dealing with the pandemic. The officials of the White House have intervened repeatedly to shape decisions and public announcements in an attempt to stage a positive response from the Administration to the health crisis.

This behavior has caused more and more career officials and political appointees to become involved in the Administration’s fight against the virus. be concerned, as the Times points out.

President Donald Trump has already advanced that there will be a vaccine before the elections – within 29 days – and has insisted on a possible “surprise”, something that has generated alarm among scientists.

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Was FDA Lax in Approving Opioids Too Easily?


By Dennis Thompson
HealthDay Reporter

WEDNESDAY, Sept. 30, 2020 (HealthDay News) — For at least two decades, the U.S. Food and Drug Administration has been approving new formulations of prescription opioids without requiring drug manufacturers to gather important information on safety and effectiveness, a new study claims.

The FDA approved dozens of these highly addictive medications for treatment of chronic pain between 1997 and 2018 based on clinical trials that:

  • Lasted no longer than 12 weeks,
  • Failed to systematically gather data on adverse events or safety concerns,
  • Actually weeded out of the final results from people who didn’t initially respond well to the drug.

“No trial was longer than 84 days, whereas people take these medicines for years and they’re labeled for chronic use,” said senior researcher Dr. G. Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health in Baltimore.

The FDA continued to approve opioid drugs based on limited and flawed information even as the opioid epidemic swept across the United States, Alexander and his colleagues argue.

“The primary harms that have driven the opioid epidemic have been because of the oversupply of opioids, especially for chronic use,” Alexander said. “The FDA has missed important opportunities to require manufacturers to produce more meaningful and clinically useful information about the safety and effectiveness of these products.”

PhRMA, the leading trade group for pharmaceutical manufacturers, responded to the new study with a statement from Public Affairs Director Jasmine Gossett.

“The biopharmaceutical industry is committed to ensuring the safety and efficacy of prescription medicines,” Gossett said. “Industry aims to bring innovative medicines to the patients that need them, while also remaining focused on the U.S. Food and Drug Administration’s regulatory requirements regarding science-based safety and efficacy throughout the process.”

More than 46,000 people in the United States died of opioid overdoses in 2018, including nearly 15,000 who died from using prescription opioids, the researchers said in background notes. The number of drug overdose deaths in 2018 was four times higher than in 1999, according to the U.S. Centers for Disease Control and Prevention.

Continued

FDA kept approving new formulations of opioids as epidemic raged

In the study, Alexander’s team reviewed all 48 new drug applications for opioid medicines approved by the FDA between 1997 and 2018, the years during which the opioid epidemic overwhelmed the United States.

Of the 48 applications, only one was for an entirely new opioid — tapentadol, marketed by Janssen Pharmaceuticals under the brand name Nucynta. The rest were new dosages, new formulations or new combinations of existing opioids such as oxycodone, fentanyl, morphine, hydrocodone, oxymorphone and tramadol.

The clinical trials that gathered data for these applications never lasted longer than three months, even though the opioids were intended for long-term use, Alexander noted.

Even as late as 2012 to 2018 — when the impact of the opioid epidemic had been widely documented across the country — the FDA still approved 16 new prescription opioids based on such short-term clinical trials, the researchers found.

These applications also failed to systematically assess well-known safety problems related to opioid use:

  • Only 38% tracked whether people developed a tolerance to the opioid, which would require greater doses to achieve the same pain relief.
  • Just 1 in 5 considered whether patients handed their prescription opioids off to other family members or sold them to acquaintances.
  • Only about 18% tracked misuse of the drug by the patients.
  • Only 13% reported opioid overdose symptoms.

“It’s one thing if a trial that was designed in 1998 excluded these outcomes, but it’s much harder to understand how a trial designed 10 years later could have excluded these outcomes,” Alexander said.

Alexander said part of the problem stems from the FDA’s acceptance of a clinical trial design called “enriched enrollment randomized withdrawal,” or EERW.

Participants in an EERW clinical trial are started on the study drug, but only patients who respond to the drug and tolerate its side effects are included in the study. Those patients who initially respond to the drug are then randomized to receive either it or a placebo.

Common trial design excluded those who didn’t respond to opioids

Defenders argue that EERW trials are necessary because most pain relievers only work in 30% to 50% of patients. Since the drugs are only effective in a minority of patients, they say, it’s better to remove in advance those who only would receive a placebo effect during the trial and instead focus on people who might really use it.

Continued

But Alexander argues that this trial design is flawed because it fails to consider the full range of potential bad reactions and lack of effectiveness that should be captured in a clinical trial.

Due to the EERW design, as many as 40% of potential participants were tossed out of these clinical trials because they didn’t initially respond to the drug, the researchers noted.

“This trial design [EERW] is controversial and fundamentally flawed, because it stacks the deck in favor of finding a product safe and effective when it very well may not be,” Alexander explained.

The FDA did not respond to HealthDay’s request for comment.

The new findings were published in the Sept. 29 issue of the Annals of Internal Medicine.

Dr. Michael Sinha, a visiting scholar at the Center for Health Policy and Law at Northeastern University School of Law in Boston, said the results align with an earlier study of his that found most new pain medications tend to be reformulations of already approved prescription opioids.

“Though two pivotal trials is the gold standard for FDA approval, the agency is increasingly willing to accept a single pivotal study as evidence of approval,” Sinha explained. “Reformulated pain medications, by definition, are not new molecular entities, so the companies can rely in part on data submitted for earlier approvals.”

Alexander said the FDA should abandon the EERW trial design, require manufacturers to conduct longer trials that gather more information regarding adverse effects, and re-label prescription opioids to reflect what has been learned about the pitfalls of chronic use.

“This isn’t a guessing game,” Alexander said. “The potential risks of these products have been exhaustively demonstrated.”

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Sources

SOURCES: G. Caleb Alexander, M.D., co-director, Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore; Jasmine Gossett, director, public affairs, PhRMA; Michael Sinha, M.D., J.D., M.P.H., visiting scholar, Center for Health Policy and Law at Northeastern University School of Law, Boston;Annals of Internal Medicine, Sept. 29, 2020



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