FDA Tells Prescription Sleep Aid Manufacturer to Remove TV AD

I don’t usually blog about prescription drugs,  I’d much rather talk about herbs, especially Chinese herbs.  But in this case, I consider this more of a “Public Service Announcement”.  Most of my readers have strong feelings against taking any pharmaceutical drugs and have an inherent mistrust of drug companies.  Here’s another reason why a growing segment of the public feels they can’t trust the drug companies or their TV commercials.

June 17, 2010:  According to Carrie Newcomer, a Regulatory Review Officer at the FDA, Division of Drug Marketing, Lunesta, a prescription sleep medication made by Sepracor, has made an “unsubstantiated superiority claims” in a TV commercial.  According to the FDA’s  letter to Sepracor.  “Promotional materials are misleading if they represent or suggest that a drug is safer or more effective than another drug, when this has not been demonstrated by substantial evidence or substantial clinical experience.”

The FDA’s has reviewed a 60 second commercial and has sent a warning letter to Sepracor to immediately cease the dissemination of violative promotional materials for Lunesta.   This drug has “warnings which include abnormal thinking and behavior (e.g., aggressiveness, bizarre behavior, agitation, hallucinations, depersonalization), complex behaviors (e.g., “sleep-driving,” preparing and eating food, making phone calls, and/or having sex, with amnesia for the event), worsening of depression in primarily depressed patients including suicidal thoughts and actions.”

 “Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination. Lunesta should not be taken with alcohol and can lead to abuse and dependence. The most common adverse reactions associated with this sleep aid includes unpleasant taste in mouth, headache, dizziness and morning drowsiness.”