Makena® is the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. FDA's June 29, 2012 Q&A can be found here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm
Full Answer
Should doctors prescribe Makena?
“We were taken aback by the amount of financial scope and influence in our specialty,” they wrote, adding that the “facts are resoundingly persuasive” that doctors should not prescribe Makena.
Does Makena have a positive benefit-risk profile?
“The totality of data on … Makena supports its continued positive benefit-risk profile and the need for continued patient access,” the company said in a statement.
Is Makena safe for pregnant women?
Covis and doctors who are advocates of the drug say Makena has few side effects and it would not harm patients to continue sales while more research is done to try to show it is effective. “Its safety profile for the mother and baby are well established,” Covis said in a statement to The Times.
Should Makena be taken off the market?
Sibai had been one of the researchers in the 2003 study of the drug and during the meeting he was called on repeatedly to answer questions. His message: Makena works and is safe, and to take it off the market would have “catastrophic” consequences.
Does Medicare cover Makena?
Makena is not covered by most Medicare and insurance plans.
Does insurance cover Makena?
As a specialty injectable, Makena can be covered by insurance plans as a pharmacy or medical benefit.
How much does Makena shot cost?
Costs. The initial acquisition cost of Makena was set at $1,440 per injection; thus, for 18 to 20 injections, the total cost was about $30,000 per pregnancy.
Is Makena generic?
American Regent announced the launch of Hydroxyprogesterone Caproate Injection, the first preservative-free, generic version of AMAG's Makena. Hydroxyprogesterone Caproate is used to lower the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Does Makena affect baby?
In a clinical study, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena. If you answer “yes” to all of the questions below, talk with your healthcare provider to see if Makena could help you reduce your risk of another preterm birth.
How much does a progesterone shot cost?
Progesterone is an injectable medication that is used to treat menstruation problems caused by a hormone imbalance. There is not a generic version currently available. The average price for Progesterone solution 50 mg/ ml is approximately $43 for a supply of 10 injections.
Does insurance cover progesterone shots?
Generic progesterone is covered by most Medicare and insurance plans, but some pharmacy coupons or cash prices may be lower. Compare progesterones.
Will Makena be withdrawn from the market?
The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena ...
Can Makena cause stillbirth?
Stillbirths have been a concern since at least 2003, when the government trial showed a small but increased risk in women taking Makena. Two percent of volunteers taking the drug had a stillbirth compared with 1% of those taking the placebo.
Can Makena cause preeclampsia?
Certain pregnancy-related fetal and maternal complications or events were numerically increased in the Makena-treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios (Tables 1 ...
Can Makena shot cause depression?
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
Can you self administer Makena?
Do not give yourself MAKENA injections. A healthcare provider will give you the MAKENA injection 1 time each week (every 7 days) either: in the back of your upper arm as an injection under the skin (subcutaneous), or. in the upper outer area of the buttocks as an injection into the muscle (intramuscular).