New State Rankings for Physician Discipline Highlight Significant Differences From State to State

A newly updated annual ranking of state medical boards by the consumer advocacy group Public Citizen has revealed widespread discrepancies in both the numbers of disciplinary actions taken against physicians' licenses, and the rates of those disciplinary actions from state to state.  Though the specific numbers have changed again this year, a pronounced trend of significant discrepancies between individual states has held constant for years.  Unless geography influences a physician's competence, these state-by-state discrepancies point to a dangerously inadequate national system of physician oversight -- one that could conceivably allow dangerous, incompetent physicians to continue to practice medicine by moving from state to state.

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Head and Neck Cancers in Young Men Traced to HPV Infection

Human Papillomavirus (HPV) -- the sexually-transmitted virus responsible for cervical cancer in thousands of women -- has now been implicated in a rapidly increasing rate of mouth and throat cancers among young men.  Researchers are hoping that a recently-approved HPV vaccine will soon be approved for boys, and tested for its effectiveness in preventing head and neck cancers.  A news article in a recent edition of the Baltimore Sun features Dr. Maura Gillison, an oncologist at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, whose research has been credited with linking the virus and tumors.

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February is National Prenatal Infection Prevention Month

Health complications during pregnancy can be scary and complicated, not to mention fatal.  Fortunately, there are a number of well-understood pregnancy-related health risks that can be eliminated through education and careful prevention measures.  The U.S. Centers for Disease Control and Prevention (CDC) offer the following infection prevention tips to ensure prenatal health, in observance of National Prenatal Infection Prevention Month:

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OB-GYN Group Advises Physicians to Adopt Sleeping Guidelines of Highway Safety Organization

Although 8 hours of sleep is recommended for all adults, the average American receives only 7, and obstetricians and other physicians may receive much less, particularly during training.  As a result of increasing awareness of the danger of physician fatigue, the American College of Obstetricians and Gynecologists (ACOG) has issued an opinion related to OB-GYN working hours in the latest issue of Obstetrics & Gynecology.

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New Mothers Not Obtaining Enough Information Regarding CMV Prevention

Congenital cytomegalovirus (CMV) infection affects 1 in 150 live births in the U.S., and 1 in 750 newborns suffer lifelong, debilitating injuries such as hearing loss, vision loss or cognitive impairment as a result of those infections.  Preventing CMV infection in babies can be as simple as instructing new mothers to wash their hands thoroughly after diaper changes -- 90% of OB-GYNs report their knowledge of this fact, but only 60% routinely counsel patients regarding hand-washing.  Only 44% counsel their patients specifically about CMV prevention.  These findings are the result of research published recently in the Morbidity and Mortality Weekly Report (MMWR), a publication of the U.S. Centers for Disease Control and Prevention (CDC).

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Unnecessary Caesarean Deliveries Linked to Increased Risk of Breathing Problems: New Study

An elective caesarian delivery can quadruple the odds that the delivered baby will suffer breathing problems when compared against those babies delivered vaginally or via emergency caesarian section.  The finding is the result of research conducted in Denmark and recently published in the British Medical Journal.

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Preeclampsia Linked to Heart Disease Risk

According to studies conducted by British and Norwegian researchers, women with cardiovascular risk factors are at increased risk of developing preeclampsia during pregnancy, and pregnant women who do develop preeclampsia are at higher risk for developing heart disease later in life. Preeclampsia, a condition in which abnormally high blood pressure develops during the second half of pregnancy, affects about 5 percent of all first pregnancies and presents serious risks to both mother and child. The findings of these studies are published in the November 2, 2007 online edition of the British Medical Journal.

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Poor Judgment, Lack of Teamwork, Insufficient Skills Cause Most Trainee Medical Errors: New Study

Most medical errors made by young physicians can be blamed on poor judgment, teamwork breakdown, and / or inadequate technical skill, according to a new study recently published in the Archives of Internal Medicine.  The study involved a comprehensive review of the closed medical malpractice claims of 5 major insurance companies, collected from 1984 to 2004. 

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National Interstitial Cystitis Awareness Day

The first-ever National Interstitial Cystitis Awareness Day was observed on October 31 this year.  The event was sponsored by the National Association of Nurse Practitioners in Women's Health (NPWH) to draw attention to a frequently misdiagnosed and misunderstood pelvic condition.  Interstitial Cystitis (IC), a painful and frequently debilitating chronic illness, is often incorrectly diagnosed as endometriosis, overactive bladder or recurrent urinary tract infection.

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Low-Fat Diet Late in Life May Protect Against Ovarian Cancer

A low-fat diet may contribute to a lowered risk of ovarian cancer in post-menopausal women, according to new research published in the Journal of the National Cancer Institute (JNCI).  The findings square with previous research linking a healthy diet to a reduced risk of breast cancer and colorectal cancer in women of the same age group.

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AHRQ Announces 10 Patient Safety Tips for Hospitals

The Agency for Healthcare Research and Quality (AHRQ), a division of the U.S. Department of Health and Human Services (HHS), recently issued a 10-item advisory for hospitals and healthcare facilities designed to improve patient safety and reduce medical errors.  Though AHRQ primarily supports research designed to assist health administrators and medical personnel, this knowledge of best practices in patient safety can also benefit the public by enabling patients and their families to advocate for safer medical care.  Following are the 10 recommendations, re-posted in their entirety:

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Standard Pregnancy Weight-Gain Guidelines Don't Apply to Obese Women: New Study

Very obese women should work to lose weight and slightly obese women should gain only a little weight during their pregnancies, according to new research published in Obstetrics & Gynecology, the official journal of The American College of Obstetricians and Gynecologists (ACOG). 

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Shoulder Dystocia: Is Your OB Ready for this Medical Emergency?

Was your obstetrician prepared for this potential emergency?  Some Hospitals are now requiring that obstetricians practice for this type of emergency on a regular basis, just like they practice CPR or Advanced Life Support techniques so that they are well prepared should they encounter this situation.   If a shoulder dystocia is not handled properly it could result in permanent damage to your child's brachial plexus muscles and this could mean the child will have limited or no use of the arm.  In many situations, this tragic outcome can be avoided by identification of mothers who are at high risk for this situation and by making sure that hospitals require obstetricians to regularly practice the accepted maneuvers.

Shoulder dystocia is when the baby's shoulder gets trapped in the pelvis and the baby cannot move down the birth canal safety.  If the doctor pulls too hard it can cause permanent injury to the child and is often called Erbs Palsy or a brachial plexus condition.  Shoulder dystocia occurs between 5-19% in cases where the baby weighs more than 8.5 pounds.  Also, women with diabetes have a greater risk of having this condition.

Calm and effective management of this emergency is critical for the baby.   The key is that the physician must be trained and ready to employ specific proven maneuvers in order to allow the baby's shoulder to be delivered without injury to the child's brachial plexus.   Prompt recognition of the condition followed by institution of specified maneuvers, such as the McRoberts maneuver, suprapubic pressure, internal rotation, or removal of the posterior arm  relieve the impacted shoulder and allow for safe delivery of the baby.

The "HELPERR" mnemonic from the Advanced Life Support in Obstetrics course can be a useful tool for addressing this emergency. All maneuvers in the HELPERR mnemonic aid physicians in completing one of three actions: enlarging the maternal pelvis through cephalad rotation of the symphysis and flattening of the sacrum; collapsing the fetal shoulder width; or altering the orientation of the longitudinal axis of the fetus to the plane of the obstruction.

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First Comprehensive Survey Of Maternal Depression


A recent study conducted by Kaiser Permanente shows that more than one in seven women are depressed at some time during the nine months before becoming pregnant, during pregnancy, or in the nine months after childbirth. The study is the first integrated survey of maternal depression and appears in the October 2007 issue of The American Journal of Psychiatry. It also found that more than half of the women who experienced postpartum depression had also been depressed before becoming pregnant or during pregnancy.

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Nursing Mothers Should Use Codeine with Caution: FDA Warning

Women who are ultra-rapid metabolizers of codeine may inadvertently expose their babies to lethal levels of morphine if they take the drug while breastfeeding.  At least one infant has recently died from a morphine overdose linked to contaminated breast milk -- the mother had been taking codeine for episiotomy pain.  The U.S. Food and Drug Administration (FDA) recently issued a warning related to the potential dangers of the drug for nursing mothers and babies.

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IUDs Safe and Effective, Even for High-Risk Candidates: New Study

Intrauterine devices (IUDs) are a safe and effective method of birth control for women at high risk of sexually transmitted diseases and pregnancy, according to a study published recently in the American Journal of Obstetrics and Gynecology.  Previously, it had been believed that an increased risk of pelvic infections meant the devices were only appropriate for use by married, monogamous women.  With this study, researchers at Virginia Commonwealth University have demonstrated that IUDs are appropriate methods of birth control for all women, except those suffering from an acute inflammation of the cervix.

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Many New Mothers Unprepared for Hospital Discharge: New Study

Approximately 17% of new mothers and their babies are prematurely discharged from the hospital, according to a study recently published in the journal Pediatrics.  Researchers polled 4,300 new mothers, their obstetricians and pediatricians to determine whether hospital discharges were occurring at appropriate times.  Eleven percent of new mothers said their discharge came before they were prepared to leave, 5% of pediatricians said babies in their care were discharged too early, and 1% of obstetricians said discharges of their patients had run afoul of good medical judgment. 

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Pre-Pregnancy Obesity Increases Birth Defect Risk: New Study

The individual health consequences of obesity are well-established, but a recent study published in the Archives of Pediatrics and Adolescent Medicine suggests that a pregnant woman's obesity can jeopardize the health of her fetus, as well.  Researchers in the study found that pre-pregnancy obesity was associated with an increased incidence of birth defects -- a finding with significant public health implications, as 51% of non-pregnant American women of childbearing age are classified as overweight. 

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Institute for Healthcare Improvement Issues Guidelines To Prevent Five Million Injuries in Hospitals

On December 12, 2006, the Institute for Healthcare Improvement (IHI) announced a national campaign intended to dramatically reduce the incidents of medical harm in healthcare institutions in the United States.  The 5 Million Lives Campaign, if successful, would be "the biggest improvement in patient safety in the history of modern health care" according to Donald Berwick, MD, MPP, President and CEO of IHI.  The campaign will focus on matters such as the adoption of various improvements in care that can save lives and prevent injuries, such as decubitus ulcers (bed sores), surgical complications and infections.

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ACOG Urges Against Paxil (paroxetine) Use During Pregnancy

"The American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant women and those wishing to become pregnant refrain from taking Paxil (paroxetine) because of the risk for birth defects.

The college's Committee on Obstetric Practice made the recommendation in an opinion published in the December issue of Obstetrics & Gynecology. It noted unpublished data from two registries suggesting a 1.5- to 2-fold increased risk for atrial and ventricular septal defects associated with paroxetine exposure in the first trimester. Based on these data, the manufacturer has changed the drug's pregnancy category from C to D.

The ACOG committee recommends that decisions about treating depression in pregnancy be individualized and that fetal echocardiography be considered for women exposed to paroxetine early in their pregnancies.

Journal Watch Psychiatry Associate Editor Dr. Deborah Cowley cautioned that the evidence reported so far is not strong enough to definitively conclude that Paxil raises the risk for cardiac malformations, but, she says, "For now, I would avoid using Paxil in pregnancy if possible." "

According to the statement by Glaxo-SmithKline, doctors should advise their patients of the potential harm to the fetus and recommend discontinuing paroxetine therapy or switching to another antidepressant.


 



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Pregnant Women With Placental Infection Have Doubled Risk Of Recurrence

As reported by Medical News Today, pregnant women who develop chorioamnionitis, an infection of the placenta or nearby membranes, in their first pregnancy have twice the risk of getting it in their second pregnancy, researchers at the UT Southwestern Medical Center in Dallas, Texas (UT Southwestern) have found.

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One in Eight Babies Born Premature

More than 500,000 babies a year are now born prematurely, a 30 percent rise in the last twenty years. CNN reports that this has translated into more than $26 billion a year in added healthcare costs. 

Researchers are calling for more studies on premature babies because, frankly, doctors do not always know what causes preterm births or how to prevent them.  Doctors do know, however, that the following characteristics put babies at higher risk for premature birth:

  • Previous preterm births (doubles the risk of a second);
  • Twins (increases the risk by 40%);
  • Poor women are at greater risk, as are those who are under 16 or over 35;
  • African-American women are 6% more likely (17.8%) to deliver prematurely than Caucasian or Hispanic women (11.5% and 11.9%).

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Medical Induction of Labor Doubles Risk of Amniotic Fluid Embolism

As reported by Medical News Today, researchers in Canada have concluded that medical induction of labor doubles a woman's risk for developing amniotic fluid embolism (AFE), a rare but often fatal complication of delivery.  AFE occurs when amniotic fluid, fetal cells, hair, or other debris enter the maternal circulation, causing cardiopulmonary collapse.  Approximately one in five births in the United States involves medical induction, and researchers believe the practice may be responsible for as many as 40 cases of AFE and 15 deaths each year in this country.  Labor induction is often medically necessary, such as when the baby is full-term and continuing the pregnancy presents a risk to either mother or baby.  However, labor induction is increasingly performed when there is no medical indication, typically for the convenience of either the physician or the parents-to-be.

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FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older

On August 24, 2006, the U.S. Food and Drug Administration (FDA) announced approval of Plan B, a contraceptive drug often called the “morning after pill”, as an over-the-counter (OTC) option for women aged 18 and older. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. It will remain available as a prescription-only product for women aged 17 and under. Plan B is manufactured by Duramed Pharmaceuticals Inc., a subsidiary of Barr Pharmaceuticals, Inc., headquartered in Pomona, New York.

The FDA Release notes that the approval concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees.  The process also provided an opportunity for public comment on issues regarding the scientific and policy questions associated with the new status of Plan B as an OTC medication. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package. With this in mind, the FDA has further noted that it remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans. 

For additional information about Plan B, please see WebMD.

Posted In Obstetrics , Patient Safety , Public Health , Women's Health Issues
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Brachial Plexus Injuries: Did Your Doctor Handle the Emergency Properly?

When a child is born with a brachial plexus injury or is diagnosed with Erbs Palsy, it may be as a result of improper management of the infant during delivery.  If you believe your child's brachial plexus injury may have been a result of improper management by the doctors or nurses, please click Regan Zambri and Long to contact us by email or call us (202) 463-3030 to discuss the situation. 

The medical term for the condition when the baby's shoulder gets stuck in the mother's pelvis is "Shoulder Dystocia."  When this occurs, it is a medical emergency.   Obstetricians should be trained and ready to deal with this situation in a calm and effective manner.  According to the American Academy of Family Physicians, a proper response begins with immediate recognition of the situation and institution of specified maneuvers, such as the McRoberts maneuver, suprapubic pressure, internal rotation, or removal of the posterior arm, to relieve the impacted shoulder and allow for spontaneous delivery of the infant. These maneuvers aid physicians in completing one of three actions: enlarging the maternal pelvis through cephalad rotation of the symphysis and flattening of the sacrum; collapsing the fetal shoulder width; or altering the orientation of the longitudinal axis of the fetus to the plane of the obstruction.  Physicians should regularly train and practice for this emergency situation so that when they are faced with it they can react appropriately and prevent this tragic injury.

In addition to arm and shoulder injuries, you should also look out for:

  •  A baby that is slow to start and may require assistance with breathing;
  • Fractures of the baby's collar bone (clavicle) or humerus (arm);
  • Repairs to the mother's vaginal area (an episiotomy) or tearing done during the birth;
  • Maternal  hemorrhage (bleeding);
  • Uterine rupture (tears in the uterus that require surgical repair).
The risk of shoulder dystocia increases when babies are larger. In fact, in babies who weigh less than 8 pounds the incidence is between 0.6 and 1.4 percent.  However, in babies weighing 8 pounds 13 ounces (4000 grams) or more, the incidence rises to 5 to 9 percent.  The single most common risk factor associated with an increased incident of shoulder dystocia is use of a vacuum extractor or forceps during delivery.

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Communication is Key to Preventing Deaths or Serious Injury of Infants During Childbirth

In the past 10 years, hospitals have voluntarily reported 47 cases of infant death or disability during childbirth to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for review under the Sentinel Event Policy.  Forty of the cases resulted in infant death and seven cases involved permanent disability. The mothers ranged in age from 13 to 41. 

According to the Joint Commission, in the cases studied, communication issues were identified as the most common root causes of the death (72 percent), with more than half of the hospitals (55 percent) citing organization culture as a barrier to effective communication and teamwork, i.e., hierarchy and intimidation, failure to function as a team, and failure to follow the chain-of-communication.

Other causes include:

  • staff competency (47 percent),
  • orientation and training process (40 percent),
  • inadequate fetal monitoring (34 percent),
  • unavailable monitoring equipment and/or drugs (30 percent),
  •  credentialing/privileging/supervision issues for physicians and nurse midwives (30 percent),
  •  staffing issues (25 percent),
  • physician unavailable or delayed (19 percent), and
  • unavailability of prenatal information (11 percent).

 The risk reduction strategies identified by JCAHO included:

  • Revise orientation and training process (70 percent)
  • Physician education and counseling (36 percent)
  • Revise communication protocols (36 percent)
  • Reinforce chain-of-communication policy (28 percent)

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Having Twins and Triplets Means Higher Risks: Is Your Doctor Prepared?

If you are wondering whether you have been seeing more twins and triplets in the past 15 years, you can stop wondering. You are.  The rate of multiple births in the U.S. has increased by more than 30% since 1990.  The increase in twins and triplets has been dramatic and according to the American College of Obstetricians and Gynecologists (ACOG), this increase is due to the use of advanced assisted reproductive techniques, also commonly called "fertility treatment".

With the rising number of multiple births, comes a rise in preterm deliveries and low birth weight babies.  Twins have a 50% chance of being born with low birth weight.   Triplets have a 90% chance of being born with low birth weight.  Pregnancies with more than one infant also have a greater likelihood of other serious complications for both mother and the infants.

If you or someone you know is facing a twin or triplet pregnancy make sure they consult with an obstetrician who has significant experience in delivery and management of multiple gestation pregnancies.   Make sure the obstetrician has explained, and the expectant mother understands, the signs of preterm labor and the importance of calling her doctor immediately if she believes she is experiencing any concerning sign.

Ultrasound is also a critical tool in evaluating a pregnancy with twins or triplets. Make sure the mother is sent to an accredited facility with sonographers who have experience and training with twin and triplet pregnancies.   If your obstetrician has the sonogram equipment in his or her office make sure the staff using the equipment and those reading the sonograms are properly trained and licensed to do so.


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Lab Errors Can Result in Patient Harm: Does your OB/GYN track your labs?

Tracking Lab Test Results and timely follow-up by your physician in terms of reviewing and acting upon all concerning outpatient tests is of paramount importance in avoiding medical errors.

According to the American College of Obstetrics and Gynecology (ACOG), every physician's office should have the appropriate procedures in place to ensure that patient's results are obtained for each test ordered.

According to Dr. Karen L. Bruden, a member of ACOG's Committee on Quality Improvement and Patient Safety, OB/GYN offices should be able to answer the following questions about their lab and testing tracking systems to ensure patient safety:

"1. Is a log kept of all cytology samples submitted to different labs? By whom?
2. Is there a mechanism for tracking delayed reports or those that were never received?
3. As a secondary safety net, are all patients instructed to contact the office regarding Pap results within a specific time period?
4. Who is responsible for receiving the cytology reports?
5. Does the physician see and initial all reports before they are filed in the patient's chart?
6. Is the cytology report attached to the chart at the time it is triaged by the physician (rather than put in a stack of "loose" reports)?
7. Are all reports triaged by the physician, or only abnormal reports?
8. If the physician reviews only the abnormal reports, who determines what constitutes an abnormal report? Are there written guidelines for the office staff?
9. What are the level of education and qualifications of nonphysician office staff who participate in the triage process? RN? LPN? colposcopy nurse? medical assistant? clerk?
10. Does the office have a "no-show" policy and mechanism in place?
11. At the end of the workday does the physician personally review the medical record of all patients who "no-show?"
12. Who is responsible for the recall of patients with abnormal cytology? Is a log kept to ensure that the patient was seen and the abnormal results addressed?
13. Is there a policy for the recall of patients who are not accessible by telephone?
14. Does the laboratory have a policy for notifying the clinician about abnormal results?
15. Is there a system for the physician to discuss results directly with the pathologist if needed?"

For more information on this topic, please visit the ACOG  website for more information regarding patient safety issues. The reader may also read more about this in the January 2006 policy statement issued by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

Posted In Cancer Misdiagnosis , Obstetrics , Patient Safety
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ACOG Position on First-Trimester Screening Methods

According to a Committee Opinion issued by The American College of Obstetricians and Gynecologists (ACOG), first-trimester screening for genetic defects is a real option for pregnant women, but only if certain criteria are met. New technologies, such as measuring nuchal translucency (NT), have allowed for earlier, noninvasive screening for chromosomal abnormalities. When combined with screening blood work in the first trimester, these methods have detection rates that are comparable to current standard second-trimester screening.

There are many advantages offered by screening in the first-trimester. When test results are negative, maternal anxiety may be reduced at an earlier point in the pregnancy. If positive, it allows women to take advantage of first-trimester prenatal diagnosis by chorionic villus sampling (CVS) at 10-12 weeks or second-trimester amniocentesis (15 weeks), as well as allow women to prepare for a child with health problems.

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Beyond the Baby Blues: New Mothers Require Early and Frequent Evaluation for Postpartum Depression

After having a baby, many women experience mood swings - one moment they feel happy, and the next they start to cry. They may feel a little depressed, lose their appetite, have a hard time concentrating, or find that they are unable to sleep well, even when their baby does. These symptoms usually start 3 to 4 days after delivery and may last several days. This mild form of depression is called the "baby blues," and it is considered a normal part of early motherhood. Some women, however, develop symptoms that are more severe and pronounced or that last a significant amount of time. This is called "postpartum depression."

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FDA: New Implantable Contraceptive Approved

According to its press release of July 18, 2006, Organon has received FDA approval for Implanon, a new implantable contraceptive .  Organon's announcement was also cited recently on WebMd Medical News, and labeling requirements are listed at FDA's website.

Implanon claims to be effective for up to three years and is implanted by a health care worker inside a woman's upper arm.  Organon, the maker of Implanon, says the device works "to continually release  a low, steady dose of progestin . . . for a period of up to three years via a unique, state-of-the-art implantable technology.  It can be removed at any time at the request of the user, after which the woman's fertility returns to her pre-existing fertility level." 

The contraceptive, which has been in worldwide use since 1998 by more than 2.5 million women runs the risk of the following potential side effects: irregular bleeding, headache, acne, and mood swings.  Clinical studies report "less than 4% of participants had complications such as redness, swelling, and pain at the spot where Implanon was implanted.  Removal complications were seen in less than 2% of participants and included broken or damaged implants and implants that had shifted slightly from their original placement."

As with other contraceptives, the use of cigarettes can raise the risk of heart disease and stroke in women who use hormonal contraceptives.  Organon strongly advises these women not to smoke.  Similarly, like other hormonal contraceptives, Implanon does not protect against AIDS or other sexually transmitted diseases.

Organon plans to sponsor a U.S. training program to instruct health care workers on how to implant the device.  Organon stated that Implanon should "become more widely available in the U.S. in 2007 with implementation of the training program."

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Deaths Following Medical Abortion: April 10, 2006 Update

It is remarkable how quickly pharmaceutical products can move through the regulatory approval process, so much so that one might question the effectiveness of research and development by manufacturers. Since the approval of mifepristone (marketed as Mifiprex) in September 2000, the U.S. Food and Drug Administration (FDA) has received reports of six deaths in the United States following medical abortion with mifepristone and misoprostol. Of the two most recent deaths reported to FDA in March 2006 (see DC Metro Area Medical Malpractice Law Blog, Deaths Following Administration of Medical Abortion), one has been determined to be unrelated to an abortion or to the use of these medications, while the other, with symptoms of infection, continues to be under investigation.

According to previous FDA reports, four women in the United States have died from sepsis (severe illness caused by infection of the bloodstream) after medical abortion with mifepristone and misoprostol. All four women were infected by the same type of bacteria. While sepsis is a known risk of abortion in general, the symptoms in these four cases were not typical of sepsis. FDA has tested batches of mifepristone and misoprostol and has not found any contamination with the type of bacteria involved in the four cases.

FDA recommends that women who have taken these medications for medical abortion contact a healthcare professional immediately if they develop stomach pain or discomfort, or have weakness, nausea, vomiting, or diarrhea with or without fever, more than 24 hours after taking the misoprostol

For historical information regarding mifepristone and misoprostol, please see Historical Information on Mifepristone (marketed as Mifeprex).

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Deaths Following Administration of Medical Abortion

The Food and Drug Administration (FDA) recently received verbal notification of two deaths in the United States following medical abortion with mifepristone and misoprostol. The notification was given by the drug's manufacturer, Danco Laboratories. While the FDA investigation is ongoing and the causes of these deaths have not been confirmed, the FDA has recommended that all providers of medical abortion and their patients be aware of the specific circumstances and directions for use of the drug as well as all attendant risks, including sepsis. In particular, providers and their patients should fully discuss early signs and symptoms that may warrant immediate medical evaluation, such as nausea, vomiting, or diarrhea, weakness with or without abdominal pain, all without fever or other signs of infection more than 24 hours after taking misoprostol.

As previously reported in its July 19, 2005 Public Health Advisory, updated on November 4, 2005, the FDA is aware of four previous confirmed deaths from sepsis in the United States, from September 2003 to June 2005, in women following medical abortion with mifepristone and misoprostol.

Information pertaining to these medications can be found at the FDA's Drug Information Page. For additional information regarding medication warnings in general, please visit the FDA's Medwatch site.

Posted In Medications , Obstetrics , Product Liability , Public Health , U.S. Food and Drug Administration Warnings , Women's Health Issues
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Pregnancy and Paxil: Not in the First Trimester

According to The Center for Drug Evaluation and Research of the U.S Food and Drug Administration, preliminary results of two important studies indicate that the popular antidepressant Paxil (also known as Pexeva or paroxetine) increases the risk of congenital defects, particularly cardiovascular malformations, when taken during the first trimester of pregnancy. Based on these findings, Paxil's pregnancy category has been changed from "C" to "D," indicating that studies show that its use in pregnant women have demonstrated an associated risk to the fetus. For these reasons, Paxil should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant. Women already taking Paxil who become pregnant or who are currently in their first trimester of pregnancy should be alerted to the potential risk to the fetus and counseled regarding whether Paxil should be discontinued and possibly replaced by another antidepressant. For certain women, however, the benefits of continuing Paxil may outweigh the potential risk to the fetus. The FDA is currently awaiting the final results of the recent studies and accruing additional data pertaining to the use of Paxil in pregnancy in order to better characterize its associated risks. The FDA will provide updates as new information becomes available.

To view the FDA alert regarding the use of Paxil in pregnancy, please click here. To visit the manufacturer's website, please click on GlaxoSmithKline.

Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings
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Lupus and Rheumatoid Arthritis Raise Pregnancy Risks

According to a study presented at the annual scientific meeting of the American College of Rheumatology in November 2005, pregnant women with lupus or rheumatoid arthritis may experience more pregnancy complications and longer hospitalizations than other women. Stanford University researchers compared delivery outcomes and hospitalizations for nearly 3,300 women with lupus and more than 1,400 women with rheumatoid arthritis to women in the general obstetric population. The study revealed that women with either lupus or rheumatoid arthritis had higher rates of hypertensive disorders, such as pre-eclampsia, than pregnant women in the general obstetric population. These women also faced higher rates of intrauterine growth restriction, premature rupture of membranes, and Cesarean delivery. As a result, women with either lupus or rheumatoid arthritis require careful monitoring throughout pregnancy, labor, and delivery beyond what is routinely undertaken.

Continue Reading Posted In Obstetrics , Women's Health Issues
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New Study Reports Effective First-Trimester Screening for Down Syndrome

Down syndrome is a disorder that includes a combination of birth defects, such as mental retardation, characteristic facial features, heart defects, and vision and hearing impairments. It is one of the most common genetic birth defects, affecting approximately one in 800 to 1,000 babies. It is generally caused by an extra chromosome, the structures in cells that contain the genetic information (genes).

According to a recently released study, a first-trimester screening test can reliably detect fetuses likely to be born with Down Syndrome, providing women with reliable information much earlier in their pregnancies than current testing permits. The $15 million study, funded by the National Institute of Child Health and Human Development, spanned eight years and involved 38,000 women.

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Ortho Evra Birth Control Patch Found Dangerous

The U.S. Food and Drug Administration (FDA) recently acknowledged what experts have been saying for months: Ortho Evra (manufactured by Ortho-McNeil) birth control patches are dangerous. The agency warned that "women who use Ortho Evra are exposed to about 60 percent more estrogen than if they were taking a typical birth control pill." Increased estrogen means increased risks, including the increased risk of life-threatening blood clots.

Continue Reading Posted In Medications , Obstetrics , Product Liability , U.S. Food and Drug Administration Warnings , Women's Health Issues
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VBAC: Trends and Continued Debate

Vaginal birth after previous Cesarean delivery, known as VBAC, has been the subject of great debate among health care professionals for many years. According to The American College of Obstetricians and Gynecologists (ACOG), the Cesarean delivery rate in the United States increased dramatically, from 5 to nearly 25 percent, between 1970 and 1988, attributable in part to physicians' reluctance to perform certain complicated vaginal deliveries as well as increasing reliance on continuous electronic monitoring of fetal heart and uterine contraction patterns.

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