Table of Contents
Why is attapulgite banned by FDA?
The FDA found attapulgite efficacy data to be inadequate and, thus, attapulgite was not included as a monograph ingredient in the April 17, 2003, final rule. Only bis- muth subsalicylate and kaolin are generally recog- nized as safe and effective as OTC antidiarrheal drugs in the final rule. years of age.
Is attapulgite banned?
Attapulgite (a type of absorbent clay) replaced the kaolinite in the 1980s, but was banned by the U.S. Food and Drug Administration in a ruling made in April 2003. As a consequence, since 2004, bismuth subsalicylate has been used as the active ingredient in U.S. marketed products.
What does attapulgite do?
Attapulgite is an oral, nonabsorbed medication that is used in the management of diarrhea. It works by adsorbing (binding) large numbers of bacteria and toxins and reducing the loss of water.
Is attapulgite safe in pregnancy?
Pregnancy and Lactation Attapulgite is not absorbed systemically. It is unlikely to pose any risk during pregnancy. There are no data available on attapulgite use while breastfeeding. Attapulgite is not absorbed.
What ingredient is in Kaopectate?
Stop use and ask a doctor if
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Bismuth Subsalicylate (UNII: 62TEY51RR1) (Bismuth Cation – UNII:ZS9CD1I8YE) | Bismuth Subsalicylate | 262 mg |
Why was kaolin and pectin discontinued?
Kaolin has been used for years in combination with pectin (Kaopectate) for diarrhea. However in April 2003, the U.S. Food and Drug Administration (FDA) found that there wasn’t enough scientific support for kaolin’s use in treating diarrhea.
Why was kaopectate discontinued?
Issue: After a recent drug recall affecting all stock on the market, attapulgite (Kaopectate®) 40 mg/mL oral suspension has now been discontinued in Canada.
Why is kaopectate discontinued?
Where is attapulgite from?
The synonym attapulgite is derived from the U.S. town of Attapulgus, in the extreme southwest corner of the state of Georgia, where the mineral is abundant and surface-mined.
Is attapulgite safe for cats?
The old formulation of Kaopectate contained only kaolin and pectin, while later formulations contain attapulgite. These substances change the consistency of the feces but have no effect on fluid or electrolyte loss. All three of these substances are safe for cats as they are not absorbed into the bloodstream.
Why was Kaopectate discontinued?
Why was Kaopectate changed?
Kaopectate was originally a trade name for kaolin and pectin in combination; however, because of efficacy issues, the company changed the formula to attapulgite in the early 1990s. Thus, there were two product formulations on the market until stocks of the older kaolin/pectin bottles were depleted.