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FDA Violations

Pfizer Removes Patient Testimonials After FDA Warning


— September 16, 2010

On the Premarin website, Pfizer had several patient testimonials in which women sang about the wonders of Premarin.  Those testimonials came to the attention of the FDA’s Division of Drug Marketing, Advertising, and Communication (DDMAC).

The DDMAC sent Pfizer a warning letter regarding the testimonials:

 The claims “seriously misrepresent what is known about the efficacy of Premarin,” since they imply that that the drug will “eliminate all hot flashes, discomfort, and other symptoms associated with menopause, and that Premarin will ‘circumvent being on menopause at all,’” according to the letter. Other testimonial statements, such as “My life after Premarin became absolutely different…I got up feeling like the day is better,” and “I started feeling very much alive again,” were also misleading, since FDA is not aware of substantial clinical evidence to back up Premarin’s ability to improve a patient’s “overall physical and emotional functioning,” the letter said.

Source: DDMAC slaps Premarin patient testimonials, Acuvail journal ad

Pfizer has since pulled the testimonials.

I wonder if the many women who have developed breast cancer while taking Premarin would like to give a testimonial for Pfizer? 

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