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FDA Has Received More Than 1,600 Adverse Events Concerning Paragard IUD

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

In spite of all its marketing bluster, Teva Pharmaceuticals, the manufacturer of Paragard, has received more than 1,600 adverse events since 2010. 

The reports include events such as the following:

  • A Paragard® IUD broke apart inside a patient and the device was removed surgically.
  • A Paragard® IUD was removed after being in place for 6.5 years and was found to be missing both arms. A sonogram revealed that the device’s arms were embedded in the patient’s uterine tissue.
  • A hospital reported four incidents where Paragard® devices fractured upon removal in 2014. According to the report, three of the four involved devices well under their expected lifespan.
  • A Paragard® device was noted to be missing the copper coil from the stem upon removal, according to a 2015 report.

Paragard is touted as “highly effective” and the only IUD that is hormone-free but serious problems, including device breakage, have plagued the company for more than a decade now. 

The FDA defines an adverse event in the following manner:

     “Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related.

Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered “life-threatening” if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death.

Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a causal relationship between the drug and the adverse event. Suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug.

Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the investigator brochure referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the investigator brochure listed only cerebral vascular accidents. “Unexpected,” as used in this definition, also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.”

In some instances, the severity and quantity of adverse events may compel the FDA to remove the medical device from the marketplace.  Teva Pharmaceuticals has already been warned about its inaccurate marketing of Paragard.  The fact that Paragard’s defects often lead to surgery may be an indicator that the device is too dangerous to be kept on the market. 

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