Amitiza Side Effects During Pregnancy Lead to Call for Stronger Warnings
The prominent consumer advocacy group Public Citizen has filed a petition with the FDA seeking a “black box” warning about the potential side effects of Amitiza for pregnant women, indicating that stronger warnings are necessary about the risk of early child birth and unintended abortions.
The petition was sent to the FDA in early May 2009, asking for the stronger warning on the label, the required distribution of a Medication Guide for all patients indicating the risk of taking the drug while pregnant and a “Dear Doctor” letter to inform healthcare providers about the risk.
“The FDA and drug makers should take every step possible to warn pregnant women and their doctors about the dangers of taking [Amitiza],” said Sidney Wolfe, M.D., director of the Health Research Group at Public Citizen. “The current label is grossly inadequate as it lacks useful information pertaining to the risks of drug-induced abortion in pregnant women who take this drug.”
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Learn MoreAmitiza (lubiprostone) is in a new class of medications known as chloride channel activators, which work by causing a release of chloride ions and concomitant fluids in the intestinal track. It was approved by the FDA in January 2006 for treatment of chronic constipation and later approved in 2008 for use on patients with irritable bowel syndrome.
The petition calls for the FDA to require a “black box” warning on Amitiza clearly indicating a risk of premature birth and abortion, and strong wording indicating that the drug should not be used by women who are pregnant or intend to become pregnant while on the medication. Additionally, Public Citizen also charges that the drug seems to have very little actual use against the ailments they were designed to treat.
In the current issue of their Worst Pills newsletter, Public Citizen recommends to readers that Amitiza should not be used at all, as there are “safer and equally or more effective treatments for both chronic constipation and for the constipation variety of irritable bowel syndrome.”
Public Citizen indicates that the drugs makers, Sucampo Pharmaceuticals Inc. and Takeda Pharmaceuticals America, Inc., noted Amitiza side effects on pregnant guinea pigs and monkeys in clinical trials. The trials found that Amitiza caused dose dependent abortions in some guinea pigs, and contractions in others. In monkeys, there were incidents of early child birth and abortion as well.
The group notes that the results were similar to the ulcer drug Cytotec (misoprostol), which works similarly to Amitiza. However, misoprostol has far more stringent labeling, particularly regarding pregnancy.
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5 Comments
KimMay 17, 2016 at 10:19 pm
I have been dealing with constipation for almost 7 years, since I had my third child. Tried every over the counter medication and would only get temporary relief at times. Had a colonoscopy only to be told I am full of stool but they don't know why so they informed me I might have IBS. I was put on Amitiza and take it twice daily. I was never told about the medication increasing the chances of get[Show More]I have been dealing with constipation for almost 7 years, since I had my third child. Tried every over the counter medication and would only get temporary relief at times. Had a colonoscopy only to be told I am full of stool but they don't know why so they informed me I might have IBS. I was put on Amitiza and take it twice daily. I was never told about the medication increasing the chances of getting pregnant. I found out a month ago I was pregnant so I stopped taking the medication after doing some research. I found out today that my baby has no heart beat. I strongly believe it's due to this medication. Do not take while pregnant and even if you stop taking it after you find out, it still might be too late. :(
michelleApril 19, 2014 at 5:50 am
I took amitiza for about 5 months. I am not on birth control but also am not sexually active so no risk of pregnancy. The amitiza made my ALWAYS REGULAR periods turn abnormal. I started getting my period a week early and then 2 days early as I got off the drug. Has amitiza been tested in girls who are NOT on birth control??? If not, they are seriously harming me and im sure millions of other girl[Show More]I took amitiza for about 5 months. I am not on birth control but also am not sexually active so no risk of pregnancy. The amitiza made my ALWAYS REGULAR periods turn abnormal. I started getting my period a week early and then 2 days early as I got off the drug. Has amitiza been tested in girls who are NOT on birth control??? If not, they are seriously harming me and im sure millions of other girls. Since ending the amitiza, I have back pain, pelvic and vaginal pain. Im worried its endometriosis. Can someone please help!!??
christineDecember 29, 2010 at 1:27 am
i just started taking beyaz and the first periodthe pains were so bad but the period didnt last that long im in second month havent gotten my period throwing up and in alot of pain i have tried the iud they had to ut it out i was on anther birth control and have had 2 lost babies cuz of it cuz i got pregnant on it i really dont think there is anything safe for us to take
BeckyDecember 26, 2010 at 11:21 pm
I take Amitzia for chronic constipation and it works like magic. I have bowel movements every day where as my whole life I was lucky if I would have a bowel movement once a week, sometimes longer. I was not only given a pregnancy test before being subscribed the drug, but I was also warned extensively by my doctor that there would be a risk of miscarriage if I became pregnant so to be careful abou[Show More]I take Amitzia for chronic constipation and it works like magic. I have bowel movements every day where as my whole life I was lucky if I would have a bowel movement once a week, sometimes longer. I was not only given a pregnancy test before being subscribed the drug, but I was also warned extensively by my doctor that there would be a risk of miscarriage if I became pregnant so to be careful about birth control and stop taking it if I became pregnant. This drug works for constipation when all other remedies have failed. I hope they don't take it off the market. It is the only thing that has worked for me.
virginiaMay 30, 2010 at 6:42 pm
was given meds and was not made aware of risks although pharmacy knew i was pregnate