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FDA Issues New Labeling Rules For Prescription Pain Pills

On September 10th 2013, The Food and Drug Administration (FDA) announced changes to the labeling requirements for prescription painkillers. The changes are to be implemented at the end of this year in hopes of curbing the abuse of these opiate medications. Prescription painkiller abuse is at epidemic proportions.  A person dies every 19 minutes from an overdose linked to prescription opiates. These deaths now exceed fatalities from illegal drug use.

FDA Commissioner Dr. Margaret Hamberg has required all labels for prescription painkillers to include text that states that the drugs should be used if “alternative treatment options are inadequate.” The labeling on the bottle is said to not be informative enough to the patient.  This gives a vague instruction as to what the purpose of these medications are for. Agency officials said the labeling changes would, “help improve the thoughtful prescribing of these medicines,” which includes Oxycontin, Vicodin, and Fentanyl to name a few.

One of the major positive changes brought to the table by the FDA is requiring producers of prescription painkillers to conduct studies on the long-term risks of taking them. The lack of long term data causes a major problem for physicians trying to determine safe prescribing practices. This could lead to colossal changes in the prescription drug industry. If these painkillers show terrible long-term effects in scientific studies, it may provide more support to help stop their abuse.

Current prescription painkiller labels say the drugs should be used for “moderate to severe pain.” Dr. Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, says this isn't quite right. “What is moderate to me could be severe to you,” he said. The new literature on the labels will say that these drugs should be reserved for use in patients who do not have other treatment options and used for management of pain that is “severe enough” to require round-the-clock treatment.

The changes were propelled by a petition from Physicians for Responsible Opioid Prescribing, an advocacy group in New York. The group, headed by Dr. Andrew Kolodny, said that he was pleased with the announcement, but he would have liked the agency to have gone further. One example would be defining limits on the duration of use and dosage.

In the near future Dr. Thockmorton and the agency will have “a series of conversations” with the manufacturers of such drugs “about what those studies and trials will look like.” Changes will be made to make these strong prescription painkillers safer for the public. Holding these companies accountable for the product they are producing only seems fair.

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