Neurontin, Gralise, Horizant; brand names for gabapentin and Lyrica, Lyrica CR or pregabalin, are currently being targetted by the FDA for causing serious breathing problems.
Gabapentin and pregabalin are prescribed for conditions such as nerve pain, restless legs syndrome and even seizures.
FDA.gov – “FDA is requiring new warnings about the risk of respiratory depression to be added to the prescribing information of the gabapentinoids. FDA has also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.”
Symptoms to keep an eye out for:
- Confusion or disorientation
- Unusual dizziness or lightheadedness
- Extreme sleepiness or lethargy
- Slowed, shallow, or difficulty breathing
- Unresponsiveness, which means a person doesn’t answer or react normally or you can’t wake them up
- Bluish-colored or tinted skin, especially on the lips, fingers, and toes
FDA.gov – Class I Recall – Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling.
Cook Medical has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014” wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018” wire guides). Marker bands that are too loose can dislodge from their original position and marker bands that are too tight can cause buckling.
The CrossCath® Support Catheters are designed to support a wire guide during access of blood vessels, allow for an exchange of wire guides, and provide a pathway for the delivery of saline solutions or diagnostic contrast agents. The catheters have three radiopaque markers spaced equally along the catheter to aid in estimating lengths within the blood vessels (vascular system).
The FDA is approving new drugs at such a record pace, and so quickly, companies are being greenlit months in advance of their normally scheduled decision dates.
Patients with rare and untreatable illnesses are excited about the news, but is this really a good thing?
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