Tag Archives: FDA

Popular Antidepressants May Put Patients At Risk For Serious Arrhythmias

By Larry Husten, Contributor In August 2011 the FDA issued a safety communication recommending that the extremely popular antidepressant citalopram (Celexa) not be used at doses greater than 40 mg/day because of a potential increased risk for serious cardiac arrhythmias associated with prolongation of the QT interval. Now a study published in BMJ lends support to this warning and suggests that other antidepressants may also prolong the QT interval.
Source: FULL ARTICLE at Forbes Latest

Gilead Challenges FDA Over Exclusivity For Its Latest AIDS Drug

By Ed Silverman, Contributor In a move that has potentially significant implications for the entire pharmaceutical industry, Gilead Sciences is challenging a crucial bit of FDA decisionmaking. The biotech wants the agency to change the way it grants exclusivity to fixed-dose combination drugs and hopes to win its argument so that more revenue can be wrung out of its recently approved Stribild HIV treatment. Specifically, an additional two years of exclusivity is at stake.
Source: FULL ARTICLE at Forbes Latest

FDA gives green light to RP-VITA hospital robot

(Phys.org)—The FDA has approved RP-VITA from iRobot and InTouch Health. This is an autonomous medical robot which will be able to make its rounds of hospital corridors in the U.S. within the next few months. The RP-VITA robot, to cost hospitals between $4,000 and $6,000 a month to operate, has the distinction of being an autonomous moving, telepresence robot that can allow doctors remotely to interact with their hospital patients.
Source: FULL ARTICLE at Phys.org

The Anguish Of Abortion: What They Won’t Tell You

By David Fiorazo

Abortion Protestor SC The Anguish Of Abortion: What They Won’t Tell You

Last week, graphic autopsy images were released of a woman dying from a legal abortion. Her mother insisted the photos be made public. The story broke my heart.

As 18-year-old Marla Cardamone lay in her casket prior to viewing, the funeral director suggested to Marla’s mother, Deborah, they close the casket so people would not see Marla’s disfigured face. Deborah Caramone told him to leave the casket open. She hopes to expose the lies of the abortion industry and wants people to understand that abortions are not always ‘safe and legal’. In order to do this, she bravely chose to show her daughter’s bruised and swollen face, caused by abortion-related complications. Marla died at a Pennsylvania hospital, and Deborah Cardamone vowed her daughter would not be forgotten.

Just a few days earlier, a medical counselor pushed Marla to have an abortion, telling her that the prescription medication she had been taking would cause her baby to be born with severe birth defects. Following Marla’s death, it was determined by doctors that her baby had no abnormalities.

Father Frank Pavone once said that “America will never resist abortion until America sees abortion.”

Thanks in part to advances in technology such as ultrasound imagery, it’s clear and easy to see a growing and moving fetus inside a mother’s womb, which has raised awareness that an unborn child is alive and human and that abortion is murder.

Americans have tolerated the evil of legalized abortion and have become so desensitized to violence and death that we don’t see eliminating innocent human life as a brutal or selfish act – or at least we don’t speak up about it enough. God have mercy on our hardened hearts.

I recently had a head-spinning conversation with a young woman about defining life. She was so disconnected with the Bible, reality, and science that she insisted that if she became pregnant, whatever it was growing inside her was not technically alive unless she was at a point in her life where she was ready and wanted to have a baby. Apparently, this is called ‘reproductive justice.’

On this 40-year anniversary of Roe V. Wade when approximately 57 million babies have been legally prevented from being born – thanks to un-elected federal judges enforcing immorality on all Americans in 1973 – Planned Parenthood receives $542 million a year from U.S. taxpayers. Some states are trying to cut off funding to Planned Parenthood, but this barely puts a dent in their $1 billion annual budget. Regardless, abortion on demand remains the law of the land.

You may have heard the numbers: 1 in every 9 women who visit Planned Parenthood ends up having an abortion, which results in one every 94 seconds. (In all abortion clinics nationwide, there is an abortion every 26 seconds.)

A new Marist poll shows that 83% of Americans favor significant restrictions on abortion. Nineteen states enacted 43 restrictions on abortion services last year, and even more restrictions were enacted in 2011. However, restricting the murder of the unborn is not enough. Even reversing Roe v. Wade wouldn’t stop the evil of man. Our culture is too far gone, and only God through Jesus Christ can change human hearts. We need to reach people with the message that every single life is a divine gift and has value.

A few weeks ago, I wrote about America’s Culture of Death: the dark history of the abortion, birth control, and eugenics movement in America pioneered by Planned Parenthood’s Margaret Sanger. It’s important to understand her warped worldview along with her atheist, feminist, and elitist mindset that justified population control in order to successfully engage in the present battle for life and morality.

Sadly, we seldom hear an extremely important part of this discussion in the pro-choice media or anywhere: the trauma of abortions often cause years of emotional pain, torment, and anguish. This is both deceptive and problematic.

Many young women who tell others about their abortion try to act normal and hide the fact that they are in physical or emotional pain. Many experience severe trauma soon after receiving an abortion. These are some of the verifiable symptoms a woman may experience:

  • Alcohol or drug use to distract from the pain, anger, anxiety (probably non-specific or in form of panic attack), and abusive relationships (believing she doesn’t deserve anything better).
  • Denial/repression (the “pushing down” of intolerable emotions), depression, deterioration of self-worth/self-image, disruption in relationships (increasing inability to be intimate or social with friends and family).
  • Eating disorders, feelings of helplessness or powerlessness, flashbacks, grief, guilt, having unprotected sex or increased sexual activity as self-punishment.
  • Nightmares about a baby crying, death, or the same nightmare over and over; preoccupation with the abortion procedure or thoughts of babies.
  • Regret, remorse, sadness to the point of inability to handle basic responsibilities, self-destructive behavior, and suicidal thoughts or attempts.

If you have had an abortion, here are a few questions to consider: What were you like before your abortion, and have you changed? Would you now advise your best friend or sister not to have an abortion if she were considering it? Did you have an abortion in spite of believing it was wrong at the time? Do you experience explosive emotions, or do you shut down? If you were a Christian before having an abortion, has your relationship with God changed?

In a study of post-abortion patients only 8 weeks after their abortion, researchers found that 44% complained of nervous disorders, 36% had experienced sleep disturbances, 31% had regrets about their decision, and 11% had been prescribed psychotropic medicine by their family doctor.

According to Priscilla Coleman of Bowling Green State University, “Women who have had an abortion have an 81% higher risk of subsequent mental health problems compared to women who have not had an abortion. Also, women who aborted have a 138% (another study showed 160%) higher risk of mental health problems compared to women who have given birth.”

A New Zealand study that tracked women for more than three decades discovered that 42% of women who aborted experienced major depression. There is accurate information available; but the media, Hollywood, government, and the abortion industry rarely address this issue.

Tragically, ignoring or denying these truths only increase chances that there will be more cases similar to Marla Cardamone’s.

In 2012, the mother of a 24-year-old woman who died after an abortion filed a wrongful death lawsuit against Planned Parenthood of Illinois. Tonya Reaves died at Northwestern Memorial Hospital July 20 after she began to hemorrhage at a Planned Parenthood clinic. They waited for over five hours before sending her to the hospital. The Autopsy stated that Miss Reaves suffered from an incomplete abortion. The story got little coverage.

Several years earlier, 25-year-old Diana Lopez was 19 weeks pregnant when she went to a Planned Parenthood clinic in Los Angeles for an abortion. Before the day was over, Ms. Lopez – just like Ms. Reaves – had bled to death from a botched abortion.

Another 18-year-old, Holly Patterson, entered a Planned Parenthood clinic in Hayward, California seeking a chemical abortion. She died seven days later (September 17) as a result of an incomplete abortion causing a severe bacterial infection. A Women’s Enews correspondent reported:

Holly had taken RU-486, an abortion drug that has been used by more than 1 million women worldwide and is widely viewed as a safe alternative to surgical abortion. But Holly died tragically of a massive infection after taking the drug protocol.

In July 2011, the FDA reported 2,207 adverse events in the U.S. after women used the RU-486 regimen. Among those were 14 deaths, 612 hospitalizations, 339 blood transfusions, and 256 infections (including 48 “severe infections”).

Tragically, many so-called ‘counselors’ at abortion clinics downplay mental and physical health risks the majority of the time in order to sell customers abortions, not to mention the fact that the procedure will violently end a child’s life. My heart goes out to those who believe the godless lie that this “procedure” is justified under the labels of choice and privacy.

In our sexually permissive and progressive culture, it’s no wonder young women are sexually active; and those who have had abortions need our prayers, not our judgment. Being a product of American culture, post-abortive women, especially religious women, are most likely suffering enough for their sin. At that point, they first need God’s forgiveness and then need to learn how to forgive themselves.

The promotion of biblical principles and abstinence education in churches, schools, and society is vital in order to affect positive change. Stop messing around, yes. Use protection, yes. Limit abortions, yes. Vote for pro-life candidates, yes. Stop funding Planned Parenthood with our tax dollars, yes! But we also need to remember the power of prayer; the Word of God; and true, caring Christianity. People may not respond to debates, laws, or rules; but they most always – eventually – respond to unconditional love. Let’s keep speaking the truth and fighting for life.

“Christ died that we might live. Abortion kills so that someone might live differently.” -John Piper

Source: FULL ARTICLE at Western Journalism

There's Value in Studying Big Pharma Pipelines

By John LaMattina When analysts review a big pharma?s future prospects, they rightly focus on those drugs that are in the last stage of clinical trials (phase 3). These are the compounds for which the most is known and whose clinical programs are spelled out in detail on ClinicalTrials.gov. While not every compound in Phase 3 will successfully navigate the development process to FDA approval, a majority of them will, thus allowing analysts a sense of what is on the horizon.
Source: FULL ARTICLE at Forbes Health

FDA Takes Action on Ambien; Concedes Women at Greater Risk

By Kai Falkenberg, Forbes Staff Zolpidem (Photo credit: Wikipedia) The FDA announced this morning that it is recommending the bedtime dose of Zolpidem (brand name Ambien) be lowered due to the risk of next-morning impairment. In a press release issued this morning the FDA says it recommending the change “because new data show that blood levels in some […]
Source: FULL ARTICLE at Forbes Latest

The FDA approvals of 2012: are we making progress?

By Bernard Munos, Contributor While we were all celebrating… FDA was working. In the last week of 2012, Santa Claus delivered 5 NDA approvals to lucky companies, boosting the year’s total to 37 (vs. 31 in 2011), an output unseen since the late 1990s. (Note: the 2012 figure excludes 2 imaging agents, florbetapir and […]
Source: FULL ARTICLE at Forbes Latest

Merck's Combination Of Ezetimibe And Atorvastatin Back On NDA Path

By Larry Husten A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year.
Source: FULL ARTICLE at Forbes Health

FDA Approves Eliquis (Apixaban) For Stroke Prevention In AF

By Larry Husten, ContributorThe FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, […]
Source: Forbes Latest

FDA Supplement Warning: Reumofan Plus Relabeled As "WOW" Still Has Unlabeled Prescription Drugs

By David Kroll, ContributorAccording to FDA, WOW is a repackaged version of Reumofan supplement, both versions of which contain three undeclared prescription drugs. Credit: FDA In the seven years that I’ve been writing online, one of my most frequent topics has been the adulteration of dietary supplements with prescription drugs. Whether intentional or a […]
Source: Forbes Latest

FDA Approves Lomitapide For Homozygous Familial Hypercholesterolemia

By Larry Husten, ContributorAegerion Pharmaceuticals said today that the FDA had approved lomitapide (Juxtapid) to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The approval comes with a box warning about the risk of hepatotoxicity and a Risk Evaluation and Mitigation Strategy (REMS) Program which will require certification of health care providers […]
Source: Forbes Latest