Safety Alert: Birth Control Pills Containing Drospirenone

The Food and Drug Administration released a safety alert regarding a higher risk for blood clots in women taking birth control pills containing Drospirenone, such as Yaz and Yazmin.

As a result of the alert, Bayer must revise Yaz and Yasmin labels to include the new FDA warning.  The new labels must report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products, according to the FDA.  The labels will also include a summary of the previously released results of an FDA-funded study of the blood clot risk.

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U.S. Regulators Want FDA More Involved with Hip Replacements, Transvaginal Mesh and Other Faulty Medical Devices

The top medical-deviceDePuy regulator of the Food and Drug Administration believes the agency needs more power to block unsafe products.  Doing so could prevent more of the faulty hip implants and vaginal mesh that have caused thousands of patent lawsuits, according to Bloomberg News.

Legislation was passed in February allowing the FDA to reject devices that were designed based on products recalled for safety flaws in the past.  In many cases, the FDA lacks proper authority, which takes away from the credibility of some device approvals, according to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

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Minor Fall Leads to Death in Patient Taking Pradaxa

In late 2011, an 83-year-old man was taken to the emergency room after falling. Shortly after his arrival, his initial scans revealed that he has been taking the blood thinner, Pradaxa. His scans showed a surprising amount of bleeding in the brain, according to a doctor at the hospital.
Soon after, the man fell into a deep coma. Scans showed that blood had nearly filled the left side of his brain and also a good portion of the right side.
He died not long after, prompting doctors at the hospital to publish a case report alerting physicians and patients to the risks of Pradaxa, including uncontrollable bleeding.

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Dosing and Warning Recommendations for Celexa

High doses of Celexa, an antidepressant, might cause dangerous abnormalities in the electrical activity of the heart, according to the U.S. Food and Drug Administration.

The Celexa drug label has been altered to contain the caution that needs to be taken when patients with certain underlying heart conditions use citalopram. The revised label also advises that lower doses be taken in patients over the age of 60.

Electrical activity changes of the heart can lead to the risk of fatal abnormal heart rhythm. Due to this risk, health care providers might need to regularly monitor the heart in patients that use Celexa. The FDA says the maximum recommended dose of Celexa is 20 mg per day for patients over the age of 60.

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Dangerous Medical Devices not tested

According to Consumer Dangerous Medical Devices not testedReports, many dangerous medical devices were never tested for safety and effectiveness. The report claims that some manufacturers do nothing more than file paperwork and pay a fee to have their medical device approved by the Food and Drug Administration.

“Standards for devices exist, they just don’t make sense,” said Diana Zuckerman, Ph.D. and president of the National Research Center for Women & Families.

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Antidepressants May Raise Risk for Pregnancy Complication

Pregnant women that take antidepressants known as SSRIs (selective serotonin reuptake inhibitors) may have a slightly increased risk of developing a dangerously high blood pressure, according to Canadian researchers.

Preeclampsia, the condition linked to SSRI use, can be harmful to both mothers and their unborn babies, according to the research. Women taking these medications should consult their doctor with any concerns before stopping usage of the medicine. Paxil and Prazac are the two most commonly prescribed SSRIs.

“We know that antidepressants should be used during pregnancy, but they should be used with caution,” said lead researcher Anick Berard. She added that the association between hypertension and SSRI use is a new finding.

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SNAP, the Bishops and a Lesson in Ecclesiology

Thomas Doyle, J.C.D.

SNAP, the Survivors Network of those Abused by Priests, came into existence in 1989, just five years after national attention was first focused on sexual molestation of minors by Catholic Clergy. The founder, Barbara Blaine, is a survivor of abuse. The national director, David Clohessy is also a survivor. SNAP came into existence because the institutional Church, i.e., the bishops, could not and would not do anything to help the victims of the priests they were supposed to supervise. Realizing that they would have to help themselves, Barbara and the original members started what has become the oldest and most effective advocacy and help group for the countless victims of clergy abuse throughout the U.S. in Europe as well. Over the years since its existence SNAP has done what the institutional Church should have done: it offered understanding, support, solace and above all, hope for anyone who called upon it. SNAP is not a sophisticated organization with a well-oiled and financed bureaucracy. It has always been focused on providing support for victims, giving them the encouragement to begin to heal from the devastation of abuse and giving them hope, knowing they are not alone.

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Antidepressants May Affect Head Size of Newborns

Women who are pregnant and taking certain antidepressants may be more likely to deliver an infant with reduced head growth, according to a new study.

According to HealthDay News, the study also discovered that although SSRI drugs, such as Prozac and Paxil, are helpful at relieving depression in women, the drugs appear to be linked to a higher risk of preterm birth.

The lead researcher, Hannan El Marroun, said, “Fetal body growth is a marker of fetal health and fetal head growth is a marker for brain development.  We found prenatal exposure to SSRIs was associated with decreased growth of the head, but not decreased growth of the body”

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Takeda Hid Actos Adverse Effects, Regulators Said

According to a whistle-blower, a U.S. unit of Takeda Pharmaceutical Co. failed to accurately report hundreds of congestive heart failure cases associated with Actos, its diabetes drug.
 
Takeda did not properly classify “non-hospitalized or non-fatal” congestive heart failure cases as serious over a two-plus year span, according to the complaint.  Drug manufacturers are required to update the U.S. FDA’s Adverse Event Reporting System.
 
“These events were not properly identified or reported in the FDA’s safety database,” former Takeda medical review Helen Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
 
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Birth Control Pills Recall

Seven lots of Glenmark Generics generic birth control pills Norgestimate and Ethinyl Estradiol have been recalled due some blister packs putting the tablets in the wrong order, causing the pills to be ineffective.
 
The recall includes oral contraceptives distributed nationwide between September 21 and December 30, 2011.  The mistake was discovered when a consumer of the pills told Glenmark the tablets in her package were in reverse order.
 
The blister packaging on the recalled pills was rotated 180 degrees, causing the pills to be in the reverse order.  The expiration date of the recalled pills is only visible on the outer pouch.  Any blister pack with no lot number or expiration date is subject to recall.
 
Consumers using the recalled pills should immediately begin using a non-hormonal form of contraception and notify their physician immediately.  The recalled pills should be returned to the pharmacy that administered them.

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