FDA MedWatch: Lovenox (enoxaparin sodium) requires dosage adjustm

[Ross]

FDA and Aventis Pharmaceuticals revised the CLINICAL PHARMACOLOGY,
PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of labeling, describing
the need for a dosage adjustment for patients with severe renal impairment
(creatinine clearance <30mL/min) who have increased exposure to enoxaparin.
No specific dosage adjustment is required in patients with mild or moderate
renal impairment and in low-weight patients. However, low-weight patients
should be observed carefully for signs and symptoms of bleeding.

Read the MedWatch 2004 safety summary, including links to the "Dear
Healthcare Professional" letter and the revised professional labeling, at:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#lovenox

 

[Guest]

Very few people on this website will need this dosage adjustment. A creatinine clearance of less than 30 ml/min means that you are getting ready to go on the dialysis list or transplant list. In other words one sick puppy.

This does illustrate something about new drugs. Lovenox came on the market in the early 1990s and now over 10 years later they have figured out that some people accumulate it and need smaller doses. You cannot learn these things from the small studies over short periods of time that are done to bring new drugs to the market. It is only by millions of people reporting adverse events that lead to valid conclusions when those events only occur in a small minority of people.

Another example is the controversy about Paxil and suicide. Fior a long time it looked like only weidros thought that there was a connection. Now it turns out that there is probably a connection. Oddly enough it may be that the drug causes people to commit suicide by making them feel better. When they were very depressed, they were too far down to follow up on their thoughts. When the drug makes them feel better, they act on their ideas. I'm going to have some fun with that one tonight. My old boss is the wife of a psychiatrist and she invited me to a BBQ at their house tonight where there will be lots of psychiatrists!! (Pueblo is the home of a big state mental hospital.)