Pharmaceutical labels: is the FDA telling the whole truth?
Posted on October 27th, 2009
Would you believe it if we told you that many key drug facts are left off pharmaceutical labels? Some of these facts could be life threatening, as is the case of a specific osteoporosis drug. If the dosage of this drug is increased slightly it could result in death. This critical information was not included on the label. Instead it was hidden in the FDA’s reviews, which are usually hundreds of pages long and filled with medical terms – making it impossible for a patient to find.
The FDA is required to approve the drug if the drug’s ability to prevent or cure a disease outweighs its side effects. It then becomes the responsibility of the pharmaceutical manufacturer to write the label and decide what information should be included. These labels have been known to play up the benefits and leave out harmful side effects. As the FDA is still responsible for approving the final label, drug experts are asking them to make this type of critical information more accessible to the public and to doctors alike. Fact boxes is what some experts are recommending. Dr. Lisa Schwartz and Dr. Steven Woloshin say that this will help patients to make more informed decisions, after all it is their health and they have a right to know!
See what else they are saying in Therapeutics Daily.
Tags: FDA, pharmaceutical, pharmaceutical labeling
Posted in FDA, Label inspection, packaging articles |
