Prevent Premature Birth with Pharmaceutical Compounding
Preterm Delivery is a serious problem in the United States, as it affects one in eight babies. In the last 25 years, the rate of preterm delivery has increased over 35 percent in the United States. Preterm Delivery increases the risk of health problems including cerebral Palsy, neurodevelopment disability and chronic illness like lung disease. 17-Alpha Hydroxyprogesterone Caproate (17P) has been proven to reduce the risk of delivery before 37 weeks in pregnant women with a history of premature birth. Weekly injections of 17P, beginning at 16 weeks and continuing to 36 weeks (20 doses), reduces the risk of premature delivery by 34%. Until recently, 17P was a generic compounded drug, without any safety or quality problems, available only through compounding pharmacies.
In February 2011, the FDA approved the first drug for preventing premature birth - Makena. The active ingredient in Makena is Hydroxyprogesterone Caproate. This new FDA approved pharmaceutical product gives KV Pharmaceuticals marketing exclusivity for 17-Alpha Hydroxyprogesterone Caproate (17P). KV Pharmaceuticals planned to charge $1,500 per dose of Makena (KV Pharmaceuticals has dropped the price of Makena to $690 per dose). For decades, Hydroxyprogesterone has been readily available through compounding pharmacies for a mere $10-$15 per dose. The cost of Makena will increase the cost of preterm delivery treatment during a pregnancy to around $30,000. Patients and payers like Health insurance companies and government programs who recently funded Hydroxyprogesterone will be greatly affected by this increase.
Compounding Pharmacies CAN Continue to Provide Affordable Hydroxyprogesterone
American's Health Insurance Plans sent a letter to the FDA questioning the award of 17P exclusivity to KV Pharmaceuticals under orphan drug status, requesting to continue having the option of obtaining compounded 17P through compounding pharmacies.
As a response, the FDA officially announced they would not take enforcement action against any pharmacy compounding Hydroxyprogesterone Caproate (17P). Although the FDA granted Makena orphan drug status, under this unique situation the option of compounded 17P is still a readily available through compounding pharmacies.
MD Custom RX continues to work with patients and doctors to provide compounded Hydroxyprogesterone keeping the drug for reducing the risk of preterm delivery affordable through pharmaceutical compounding. Reducing the risk of preterm delivery decreases the risk of your baby having long term, life threatening health problems. Through the triad relationship of patient, physician, and pharmacists, all three can work together to help reduce the risk of premature birth.
Ask your doctor about compounded 17P Hydroxyprogesterone from MDCustomRx Brookfield Wisconsin
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