September 19, 2012
Technology has made fascinating advances in medical practice and ultrasounds are no exception. However, contrary to popular belief, they are not a tool developed so that women can find out the sex of their baby. While that is a great benefit to expectant parents who “just have to know,” the true purpose of having an ultrasound is to make certain that your baby is doing well, to measure its growth and to help a healthcare provider make a decision if he or she suspects there is a problem. So when and why should you have an ultrasound? Here are 10 good reasons that can be found in The Smart Mother’s Guide to a Better Pregnancy:
- To determine the age of the pregnancy
- To document that the baby is alive
- To determine the position of the baby
- To determine “normal” anatomical organs, usually after 18 weeks
- To determine the position of the placenta
- To determine the cause of bleeding
- To determine whether you are having more than one baby
- To document that the baby is in the uterus and not a fallopian tube
- To measure amniotic fluid late in the pregnancy
- To periodically watch the baby if you have a high-risk condition
There will be temptation for pregnant moms to get “keepsake” ultrasounds done in the mall for entertainment purposes. Not only are those ultrasounds not approved by the FDA but they could potentially miss an important diagnosis if they are not read or interpreted by a physician. The conditions listed above will give you legitimate reasons for requesting an ultrasound that can be done by a professional under the supervision of a doctor.
Remember, a healthy pregnancy doesn’t just happen. It takes a smart mom who knows what to do.
September 12, 2012
There are few times that I become gravely concerned about the way medicine is practiced and this is one of them. A recent medical study in the Journal of Hypertension reported some startling facts: pregnant women are receiving blood pressure medication that might be harmful to their babies.
When physicians decide to specialize in obstetrics, we know exactly what we’re getting into. We have two patients, both mother and unborn baby and we don’t want either to die. Each year 4 million babies are born in the U.S. and between 6 to 8% of their mothers will have high blood pressure. Why are physicians and healthcare providers concerned about high blood pressure? Because if untreated, it can cause a stroke leading to death.
During pregnancy, a patient can have there are 3 types of high blood pressure: (1) chronic hypertension that occurs before 20 weeks, (2) gestational hypertension that occurs after 20 weeks but is not associated with protein in the urine and (3) pre-eclampsia that occurs after 20 weeks and is associated with protein in the urine. Pre-eclampsia, if untreated can lead to seizures (also known as eclampsia) and strokes. It is one of the most common reasons for death as a result of pregnancy. The treatment for pre-eclampsia is the delivery of a baby because the placenta is causing a problem. If the patient’s blood pressure is extremely high and life-threatening, medicine is also given to prevent the woman from having a stroke until she is delivered.
On the other hand, chronic hypertension is treated with medication during pregnancy to prevent strokes from occurring. But what type of medicine? The FDA classifies medicines in 5 categories from “A” to “X” to describe how they will affect the unborn baby. Category A poses no harm to the baby and Category X should never be given because it has been proven to cause birth defects. The blood pressure medication Lisinopril is a category X medication. It should never, never be taken during pregnancy.
Pregnant moms please read those labels and ask questions before taking medication. A healthy pregnancy doesn’t just happen. It takes a smart mom who knows what to do.
October 3, 2011
It depends on the method and whether the mother plans to breast feed. Ideally, it is recommended that women abstain from sexual relations for at least 4 to 6 weeks after having a baby to reduce the risk of developing vaginal infections and of course, becoming pregnant.
Pregnant women have an increased risk of developing blood clots because of hormonal changes. This is commonly referred to as a hypercoagulable state. Birth control pills that contain both estrogen and progestin (aka combination pills) are not recommended for the first 42 days after the delivery because they increase the risk of blood clots in the legs (Deep Venous Thrombosis, aka DVT) and also decrease breast milk production. The vaginal ring and patch are also not recommended. However, birth control pills that only contain progestin are safe to take immediately after delivery because they don’t increase the risk of developing blood clots nor do they reduce the amount of breast milk production. The Depo- Provera injection may also be given as well because it is a progestin-only product. What women are at increased risk for developing a DVT? Women who are
- Over 35
- Had previous DVTs
- Had a history of postpartum hemorrhage
According to the Center for Disease Control (CDC), a woman may use combination birth control pills 21 days after having a baby if she is not breastfeeding.
Can a woman have an intrauterine device (aka IUD) inserted after she delivers a baby? Only if it can be inserted during the first 10 minutes after the placenta has been delivered. According to a recent article in OBGManagement, the FDA has approved immediate placement of the copper IUD (aka Paragard) after a delivery. Why can’t the IUD be placed after the first 10 minutes? Because the chances that it will be expelled or fall out of the cervix are increased by at least 12 to 24 percent if it is inserted between 10 and 48 hours after delivery.
So, is it safe to use a birth control method immediately after having a baby? Yes, provided those methods are
- Progestin only products which include pills, the Depo-Provera shot and progestin implants
- Tubal ligation which is a permanent method of sterilization
- The IUD if it is inserted within the first 10 minutes after the placenta is delivered
There are approximately 4 million babies born each year in the U.S. According to CDC, half of them are unintended. A pregnancy that occurs less than six months from the last increases the risk of complications to the mother. Therefore, choose wisely and choose safely. A discussion with your healthcare provider before your baby is born is probably not a bad idea.
June 1, 2011
Of the 4 million babies born in the U.S. each year, approximately 12.3 percent of them will be premature and 3.56 percent will occur before 34 weeks. Premature birth is one of the leading causes of severe handicaps and has an annual cost of approximately $26 billion dollars. Although risk factors for preterm labor have been identified, there is still no cure. As stated in a previous blog post, when the cervix becomes weak (a condition called cervical insufficiency), the patient is at risk for second trimester miscarriages and preterm labor. Also, if a patient has a previous history of premature birth then she needs her cervix measured in a future pregnancy. If her cervix is short and measures between 16 mm and 25 mm before 23 weeks, she is at risk for premature labor and delivery. The recommended treatment for a short cervix is either progesterone suppositories or injections. A few months ago, there was profound controversy over an FDA approved injection that would cost approximately $1500.00 if purchased by the manufacturer, K-V Pharmaceuticals. Bending under political pressure, K-V reduced their price to $690.00.
The more options that are available for treatment of premature labor, the greater the chances are of achieving a full term baby. In the past two months, a new study has emerged which describes a progesterone gel that reduced birth rates before 33 weeks by 45 percent and improved newborn outcomes. This is a significant result. The earlier a preterm birth occurs, the greater the risk of having a baby who will subsequently have brain damage or physical handicaps. Therefore, the progesterone gel has great potential regarding reducing obstetrical complications. It will also provide patients with an option other than reliance on the progesterone injection. What are the differences between the progesterone injection and the gel? The injection is given once a week in the muscle but the gel has to be used daily. An injection has to be given, but the gel can be self-administered. The treatment should ideally begin at 16 weeks but no later than 21 weeks and must be continued until 37 weeks or delivery.
Any pregnant patient with a history of preterm labor should have seek early prenatal care and have their cervix measured via an ultrasound. If it is 25 mm or less, then the use of the progesterone gel might be a viable option in the near future.
Remember, a healthy pregnancy doesn’t just happen; it takes a smart mother who knows what to do.
April 4, 2011
This post is written as a follow-up to The Hijacking of Pregnant Women.
It is said that sometimes you have to rock the boat in order to shift the course of progress. Well today pregnant women have reason to celebrate. The winds of change are apparent.
Bowing under pressure, K-V Pharmaceutical Company reduced the price of Makena from $1500 to $690. Makena is the trade name for hydroxyprogesterone caproate or 17OHP. It is a drug recently approved by the Federal Drug Administration (FDA) to reduce premature deliveries before 37 weeks if it is given before 21 weeks gestation. It has been used for years as an off-label drug and costs approximately $10 to $20 to make by compound pharmacists. When the FDA gave K-V an exclusive right to manufacture the drug, their integrity flew out the window. The pricing strategy of K-V is a case study of corporate greed. Most drug companies will use the “research and development” logic to explain their rationale for marking up the cost of a drug. In the case of Makena, that excuse is valid. The research and development of Makena had already been done by Squibb Pharmaceuticals who had sold the drug for years. Is it any wonder why U.S. citizens will cross geographic borders and purchase drugs from their Canadian and Mexican neighbors?
Kudos are in order to the American College of Obstetricians and Gynecologists (ACOG) who took the lead in questioning K‑V’s pricing strategies. The Society of Maternal Fetal Medicine, the American Academy of Pediatricians, the National Medical Association, the American College of Midwives and the Association of Women’s Health and Obstetric and Neonatal Nurses should also take a bow. To their credit, ACOG refused to accept any advertising from K-V regarding Makena, a decision that reduced their potential revenue but saved the lives of future generations. The FDA is also to be commended for allowing compounding pharmacies to continue to produce 17OHP which means pregnant women can purchase the drug for $10 to $20 as opposed to the K-V $690.00 sticker price. What a moral victory.
Perhaps the infamous words of Mark Twain say it best: “Always do right. This will gratify some people and astonish the rest.”
A healthy pregnancy doesn’t just happen, it takes a smart mother who knows what to do.
March 23, 2011
Periodically, the FDA publishes drug warnings that should be shared with the public, especially if it affects pregnant women. Each year, over 4 million babies are born in the US and 43% will continue to be breast fed at 6 months. All of these moms will invariably use meds at some point after birth, so which meds are helpful and which are potentially harmful? These questions may now be answered by the Infant Risk Center, at the Texas Tech University Health Center, in Amarillo, Texas. This center provides up-to-date information regarding the safety of medications that are taken both during pregnancy and after birth.
Most drugs enter breast milk immediately after birth and during the first 4 to 10 days of life at a fairly fast rate based on the physiology of breast cells. New moms must therefore be careful of pain medications that are prescribed during the post partum period. Hydrocodone aka Vicodin is a potentially addictive opiate that is given for pain management. When it is processed by the body, it breaks down into a component called hydromorphone that is even more potent. The University of California at San Diego Medical Center performed a small study to determine how much of the drug is secreted into breast milk and what percentage is absorbed by newborns. 3 to 4% of hydromorphone was found in breast milk which is considered safe. As a rule of thumb, nonopioid medication should be prescribed first during the post partum period for pain relief. If the pain persists, no more than 6 Vicodin (hydrocodone) tablets or 30 mg should be prescribed in one day. Dosages greater than 40 mg should be avoided and the newborn should be monitored carefully for depressed behavior or inadequate breastfeeding.
Recently the FDA sent a drug warning to healthcare providers regarding the risks associated with the entire class of antipsychotic medications such as Haldol, Risperdal®, Risperdal® Consta®, Invega® and Invega®Sustenna, Clozaril, Zyprexa, Seroquel, Abilify, and Geodon. These medications are used to treat schizophrenia and bipolar disorders but are associated with abnormal muscle movements and withdrawal symptoms of newborns whose mothers took these medications during the third trimester. However it is recommended that patients should not abruptly stop taking these medications without speaking with their healthcare professional first. For further information, readers may go to the FDA website http://www.fda.gov/Drugs/Drug Safety/ucm243903.htm.
Remember, a healthy pregnancy doesn’t just happen. It takes a smart mother who knows what to do.
March 14, 2011
So, here we go again. Yet another slap in the face by big Pharma. Something is fundamentally wrong when a company charges $1,500.00 for a $10.00 drug that will not only save the lives of human beings but also reduce the annual $26 billion dollar cost of premature births.
Hydroxy progesterone caproate, marketed as Makena, has been around since 1956 and has been used for the past 15 to 20 years to help reduce premature births. It was originally manufactured by Squibb Pharmaceuticals but was removed from the market for reasons unknown. However, physicians were able to continue prescribing the drug by having it made in compound pharmacies for $10 to $15 per injection. The FDA subsequently gave KY Pharmaceuticals the exclusive right to produce the drug. Well, that was a glaring mistake. Why would the FDA want to give a company EXCLUSIVE rights to produce the drug? In a free market, competition is critical in keeping prices down. Twelve percent of births in the U.S. occur prematurely and a disproportionate number are African American women and teens. The drug has to be given between the 16 to 20th week of pregnancy and continued up until 36 weeks. Let’s do the math. The medicine has to be injected weekly. A patient taking the drug beginning at 16 weeks will have to continue taking it for approximately 20 weeks and 20 x $1500 =’s $30,000. So what originally costs $200 to $300 to prevent preterm pregnancy has now spiked to $30,000. How many different ways can we spell the word, GREED?
The prevention of premature births is paramount to the well-being of a newborn. Makena is not an optional drug. It will benefit many unborn babies and especially those whose mothers have a short cervix. Because Makena is now an FDA approved drug, the off-label brand previously made by compound pharmacists is not an option because of liability issues. Do you really think the insurance companies are going to pay $1500 for this drug?
I leave you with a profound quote from one of my readers, Dorice Arden:
“. . . a shocking reminder of just how low the value for humanity has sunk. The notion that patients are considered a commodity has far-reaching consequences. The very thread that ties us to our humanity is the value we place on life and life-sustaining measures. The attention and care we share with each other sets the tempo for the future.
Well said, Dorice. Well said.
November 29, 2010
While it is important to support our country’s national security, there has to be a voice of reason. In Christmas of 2009, a 23-year-old terrorist hid an explosive device in his underpants that went undetected because of its nonmetallic ingredients and the world was never the same again. The Department of Homeland Security shipped 385 full-body scanners to 68 U.S. airports this year with 1,000 more projected for 2011. Perhaps this decision was premature. At the center of the controversy is whether these scanners are safe, especially for pregnant women, the elderly and children despite claims to the contrary made by federal officials.
Physics professors and scientists from universities in California and Arizona have purported that the radiation of body-scanners is 10 times greater than what the TSA estimates and will increase the risk of cancer to children and other vulnerable populations. At question is whether the airport scanners will dump large amounts of radiation into the skin and tissue resulting in undesired side effects. Although the scanners were FDA-approved, the machines passed a test developed by the very companies that manufactured them thereby suggesting a possible conflict of interest. And if the pictures of the scans are not clear, will the untrained TSA workers simply raise the dose, thus placing passengers at a greater risk for radiation exposure?
The Allied Pilots Union has rejected the use of body scanners thus making the issue as clear as mud. If the pilots don’t want to use the body scanner, why should pregnant women? The Center for Disease Control (CDC) has published helpful facts about radiation and pregnancy:
- Radiation exposure before birth can increase a person’s risk of getting cancer later in life
- Unborn babies are especially sensitive to the cancer-causing effects of radiation
- If the radiation dose to the fetus was roughly equivalent to 500 chest xrays, the increase in lifetime cancer risk would be less than 2% above the normal lifetime cancer risk of 40 to 50%
- During the first 2 weeks of pregnancy, the radiation-related health effect of greatest concern is the death of the baby. The fetus is made up of only a few cells during the first 2 weeks of pregnancy. Damage to one cell an cause the death of the embryo before the mother even knows she’s pregnant.
- Large radiation doses to the fetus during the more sensitive stages of development (between 2 and 15 weeks of pregnancy) can cause birth defects, especially to the brain
- Between the 16th week of pregnancy and birth, radiation-induced health effects are unlikely unless the fetus receives large doses of radiation
- After 26 weeks, the radiation sensitivity of the fetus is similar to that of a newborn. This means that birth defects are not likely to occur and only a slight increase in the risk of having cancer later in life is expected.
The bottom line? Pregnant women should NOT be subjected to body scans at airports. The risks far outweigh the perceived benefits. We need a voice of reason to protect pregnant women and their unborn. I hope the American Medical Association, the American Congress of Obstetrician-Gynecologists and the American Board of Obstetrician-Gynecologists are listening.
January 11, 2010
Just when I think that I’ve seen and heard it all, I read yet another bizarre story that proves me wrong. Last month CNN reported a story about a woman who had attempted to end her rival’s pregnancy Woman Tried to End Rival’s Pregnancy, Prosecutor Say in a most deceptive way.
Kisha Jones was arrested for allegedly tricking Monique Hunter, her husband’s pregnant lover into taking an abortion-inducing drug. Jones allegedly forged a physician’s prescription and prescribed a medication that would induce early labor. She told the pharmacist that the medicine was for “a procedure.” She then called Hunter and convinced her that her physician had prescribed an important medication and she should pick it up and take immediately. Hunter complied. Shortly thereafter, she was soon rushed to the hospital and delivered a premature baby boy two months early.
While Hunter’s baby was still in the intensive care unit, an unknown man brought what he claimed to be breast milk for the baby and it was later determined to be poison. The hospital staff called the police and Jones was arrested on a host of charges including criminal impersonation. The facts of this case suggest that either Jones was familiar with labor inducing medications or knew someone who was. The “abortion-inducing drug” referred to by CNN was probably Mifepristone.
Mifepristone is a medication that’s used for early first-trimester abortions and to induce labor with fetal demises. Since its inception back in the late ‘80’s, I have disagreed with it being prescribed as an outpatient medication. Any medicine that causes bleeding and the evacuation of the uterus should be done in a controlled environment under the supervision of medical staff to avoid complications. Unfortunately, the FDA has reported several deaths of women who had taken this medication at home.
While this story has all of the makings of daytime drama, the bigger tragedy is that an innocent newborn was almost killed. I think the FDA should reexamine its policy regarding Mifepristone. People like Kisha Jones should never be allowed to strike again.
November 4, 2009
The panic continues. The FDA had granted the use of unapproved drugs in the treatment of the 2009 H1N1 Influenza virus. Through an Emergency Use Authorization (EUA), the experimental drug, Peramivir has been allowed to treat hospitalized patients with H1N1 influenza that includes pregnant women, babies and children up to age 17. Peramivir is not approved by the FDA for use in the U.S. because its patient safety has not been established.
Peramivir is an antiviral medication, similar to Tamiflu® and Relenza® but is given in the veins. It is helpful for patients who are unable to swallow meds, have an allergy to Tamiflu® or Relenza® or are not responding to oral or nasal medication. However, treatment with Peramivir should be considered a “Hail Mary Pass.” It is used when all else has failed. While the FDA believes that known and potential benefits of Peramivir outweigh its known and potential risks, a closer look at the FDA’s statistics is on order.
According to the Emergency Use Authorization of Peramivir IV Fact Sheet for Health Care Providers the following statistics are enlightening:
• Only 1,891 clinical trials patients in the US were given any form of the drug
• Out of 1,891 patients tested, NONE were children, pregnant women or nursing mothers
• Out of the 1,891 clinical trial patients, only 478 received a “single-dose” regimen similar to what might be given in a hospital setting
• Out of 1,891 patients, only 33 patients received a 600 mg dose for five days or greater
It is not surprising that the drug cannot be deemed “safe” with such a small patient sample.
The FDA also reports that 10 percent of all human subjects experienced adverse events including four percent who received the 200 mg dose and seventeen percent who received the 400 mg dose. The most frequent adverse reaction was pneumonia. The FDA recommends a 5-to-10 day treatment of Peramivir 600 mg given once per day.
Let’s hope we will remain healthy and never have the need for Peramirvir. However knowledge is power. At least we now have the facts.