On November 14, 2018, the FDA issued a safety communication in which it warned that patients undergoing treatment or management of pain who are given pain medicines in the spinal fluid (intrathecal administration) that are not FDA approved for use with the implanted pump may be subjected to additional risks including dosing errors, pump failures, and other safety concerns.
Implanted pumps are medical devices that are surgically implanted under the skin, typically in the abdomen. They are connected to an implanted catheter and are used to deliver prescription medicines and fluids within the body, including the intrathecal space (into the spinal fluid), to treat pain, muscle spasticity, and other diseases or conditions. Implanted pumps are periodically refilled with medicines or fluids by a health care provider. They are often used to treat or manage pain after other treatments, such as oral medicines, physical therapy, or surgery, are unsuccessful.
The FDA-approved implanted pump labeling identifies which pain medicines are approved for use with each pump. Pain medicines approved by FDA for delivery into the spinal fluid must meet additional safety standards because the spinal cord and brain tissue are highly sensitive to preservatives or infectious organisms such as bacteria or viruses.
The FDA has received numerous Medical Device Reports (MDRs) describing adverse events with implanted pumps that describe pump failures, dosing errors, and other potential safety issues. Patients’ symptoms described in the MDRs include pain, opioid withdrawal, fever, vomiting, muscle spasm, cognitive changes, weakness, cardiac and respiratory distress.
Pain Pump Failure
Pain pump failure can occur independently of the type of medicine used but the FDA warns that the pain pump failure rate may more than double when medicines not approved for intrathecal administration with the pump are infused. Because not all medicines (such as compounded drugs) have been evaluated for compatibility with the components of the pump, there is an increased risk for part failure that may lead to earlier than expected surgical removal or replacement of the pump (e.g., some medicines or fluids may contain preservatives or other characteristics that can damage the pump tubing, or lead to corrosion of the pumping mechanism, which may cause the implanted pump to perform in unexpected ways including pump motor stalls, which ultimately stops the medication delivery, leading to potential medicine withdrawal symptoms).
Programmable implanted pumps have dose calculation software that provides options for users to select pre-programmed medicines and concentrations identified in the approved pump labeling to help prevent unintended dosing errors. The accuracy of the software calculations are dependent on using the approved medicine, medicine concentration, and medicine characteristics. For example, if there is more than one medicine in the pump reservoir, the pump software can only calculate the dose based on a single infusion rate.
Using a higher concentration of a medicine to fill a pump may prolong the amount of time between pump refills. However, it is known that due to technological limitations of these pumps, the lower the infusion rate, the greater the risk of flow rate inaccuracy. Therefore, the patient may not receive the intended dose at very low flow rates, potentially leading to symptoms associated with under-dose or over-dose.
The FDA further warns that the spinal cord and brain tissue are highly susceptible to the effects of medicines given intrathecally. Medicines approved by FDA for intrathecal injection must meet additional safety standards to ensure they do not damage these sensitive tissues. These standards are greater than those for medicines approved for different routes of administration such as an injection into a vein or muscle. If the implanted pump is filled with a medicine that is not approved for intrathecal injection, the medicine itself may be toxic to the spinal cord and brain tissue or there may be infectious agents present. In addition, the interaction of the materials between the pump system and medicines not approved for use in the pump is unknown, and could also be toxic to the spinal cord and brain tissue.
Additionally, the use of some highly concentrated medicines are associated with granuloma formation (inflammatory mass) at the tip of the catheter or infusion site. Granuloma formation may lead to pain and neurological deficits due to compression of the spinal cord or nerves.
If you or a loved one suffered injury or other harm while using a pain pump in the United States, you should promptly consult with a pain pump lawyer (medical device claim lawyer) in your U.S. state who may investigate your pain pump claim for you and represent you or your loved one in a pain pump lawsuit, if appropriate.
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