What is the date that the FDA appoved Depo Provera?

Question

I am also interested in the long term effects of this drug.

Answer 1

It was first approved in the sixties as a medical suppressive for Endometriosis. The FDA refused, however, to grant approval to the maker, Upjohn Pharmacia, over and over, repeatedly for contraception, until it finally got passed in 10/29/92 [http://www.fda.gov/bbs/topics/NEWS/NEW00303.html].

On November 17, 2004, the FDA and Pfizer (the current company formerly known as Upjohn) "black boxed" Depo Provera, meaning it has an official warning on the lable [Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection. Retrieved on 2006-05-12] concerning the potential toxicity and osteoporosis risks. The drug is also known for the rare, but possible, failure of the patient to ever ovulate again.

For side effects see:

http://www.fda.gov/MedWatch/SAFETY/2004/DepoProvera_deardoc.pdf

http://multinationalmonitor.org/hyper/issues/1985/02/problems-us.html

Hope that helps.

Answer 2

October 2000

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