The FDA, as part of its routine monitoring and surveillance program designed to protect consumers from overly aggressive marketing or misleading information about drug and medical device products, has issued a warning letter to AMAG Pharmaceuticals, Inc. concerning its drugs GastroMARK® and Feraheme™ for violating the Federal Food, Drug and Cosmetic Act and for failing to submit a copy of their web pages about the drug to the FDA.
GastroMARK is used or taken orally in adult patients who need MRI’s to help distinguish the bowel from other organs and tissues that are near the upper regions of the gastrointestinal tract. However, its usefulness in the lower gastrointestinal tract is limited.
Feraheme™ is used or injected in adults in the treatment of iron deficiency anemia in patients with chronic kidney disease. Feraheme is not safe for patients with iron overload or for anemia not caused by iron deficiency.
Both the GastroMARK and the Feraheme websites failed to identify risks associated with the drugs. The websites failed to provide important information about what the drug was approved for, and they suggested misleading or unapproved new uses for the drugs.
These violations are concerning to both patients and doctors because they suggest that these drugs are appropriate and safe for a wider range of conditions than has been established by clinical experience.
Consumers must remain vigilant about drug and medical device companies. Too often, these companies put profits ahead of patient safety. Be sure to question your doctors about their choice of drugs and devices they recommend to you. Be sure you understand the risks and side effects before you take a prescription drug. If you believe you have been the victim of an injury related to an unreasonable side effect from a drug or if you believe you are the victim of a failed or defective medical device, you should not hesitate to look for legal representation. Your ability to hold these manufacturers financially responsible for their actions is a critical important factor in preventing future misdeeds.