April 29th, 2011 by Linda Burke-Galloway, M.D. in Health Tips, News
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The Federal Drug Administration (FDA) recently issued a new warning about a medication that has been used for years and it has sent shock waves throughout my specialty. Terbutaline is an FDA approved medication that is used for asthmatic patients or patients who have significant narrowing of the airways. However for years it has been used as an “off-label” medication to treat preterm labor but now that’s about to change. An off-label drug means it hasn’t been approved for that specific use by the FDA.
According to the FDA, the injectable form of Terbutaline should only be used for a maximum of 24 to 72 hours because the drugs association with heart problems and death. The FDA goes on to say that the oral version (pills) should not be prescribed to treat preterm labor because it’s ineffective and can cause similar problems. As an obstetrician, I feel utterly betrayed. The medication clearly had side effects that included shortness of breath and a racing heart. As resident physicians we were taught that the benefit outweighed the risks of having a premature baby and the patients should try to adjust to the medication. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
April 17th, 2011 by Linda Burke-Galloway, M.D. in True Stories
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Olympic winner and motivational speaker, Jim Stovall once said “Integrity is doing the right thing, even when no one is looking.” In September 2009, I wrote about a blog about Carolyn Savage, a 40 year old woman with a poor obstetrical history. Savage married her college sweetheart and had an uncomplicated first pregnancy. However, her second child was born prematurely. She had 4 subsequent miscarriages and ten years later she became pregnant through in-vitro fertilization (IVF). Because the Savages wanted a large family, they tried IVF again. Unfortunately, Savage was impregnated with the wrong embryo. To their credit, everyone rose to the highest level of integrity. The infertility clinic informed the Savage family as soon as the mistake was discovered and then gave them the option of terminating the pregnancy or continuing it. The Savage family then had to inform the rightful parents of the embryo that were not expecting to have a baby any time soon but was now faced with that dilemma. Savage ultimately delivered the baby and then handed it over to its rightful parent, the Morrell family. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
April 13th, 2011 by Linda Burke-Galloway, M.D. in News, Opinion
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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. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
April 6th, 2011 by Linda Burke-Galloway, M.D. in Health Tips, True Stories
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When we hear about maternal death, we immediately think of a third world country but in reality, 2 to 3 women die every day in the U.S. from pregnancy and childbirth. Unfortunately, African American women are affected disproportionately and are four times more likely to die than anyone else. The tragedy is that at least half of these deaths are preventable.
In her article, Special Report: Black Women Die Nearly Four Times the Rate of White Women From Pregnancy Complications, Rita Henley Jensen, describes the dilemma of the acting chief of the maternal and infant unit of CDC, Dr. William Callaghan. Callaghan can’t sleep at night because he wants to know why pregnancy is more dangerous for U.S. African American women.
During my residency training, I witnessed a maternal death. Read more »
*This blog post was originally published at Dr. Linda Burke-Galloway*
March 28th, 2011 by Linda Burke-Galloway, M.D. in Health Tips, News
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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.
*This blog post was originally published at Dr. Linda Burke-Galloway*
The Federal Drug Administration (FDA) recently issued a new warning about a medication that has been used for years and it has sent shock waves throughout my specialty. Terbutaline is an FDA approved medication that is used for asthmatic patients or patients who have significant narrowing of the airways. However for years it has been used as an “off-label” medication to treat preterm labor but now that’s about to change. An off-label drug means it hasn’t been approved for that specific use by the FDA.
