November 14, 2011
Last Tuesday, the Food and Drug Administration (FDA) issued as statement in regards to its enforcement policies surrounding the compounding of the active ingredient in the drug, Makena, which is hydroxyprogesterone caproate.
The drug was recently approved in February of this year for use in women at risk of preterm births. Shortly after that approval, the drugs manufacturer, K-V Pharmaceuticals, sent out letters to pharmacists saying that the FDA would no longer exercise enforcement discretion on compounded versions of the drug. When the agency caught wind of this they issued a statement that they would be enforcing regulations on the compounding of the ingredient to ensure purity, quality, and consistency in the manufacturing process in able to ensure that the drug will be safe for consumers.
In October of this year, the FDA received information from K-V Pharmaceuticals that samples of the companies bulk hydroxyprogesterone caproate active pharmaceutical ingredients (APIs) and compounded hydroxyprogesterone caproate products had variances in purity and potency. These findings sparked the FDA to conduct their own tests in the company’s laboratories. In the meantime, they are suggesting that before accepting the new application for the drug, physicians and patients review all the information surrounding the drug and try not to use compounded versions.
The Colorado Drug Injury Lawyers with the McDivitt Law Firm would like to urge patients to always consider the risks before taking any medication your doctor is suggesting. Also, never be afraid to get a second opinion before starting a medication regimen.