How are drugs classified for pregnancy?

How are drugs classified for pregnancy?

According to the FDA, drugs are classified as Category C “if animal reproduction studies have shown an adverse effect on the fetus, if there are no adequate and well-controlled studies in humans, and if the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.”1 As an …

What is a Category C drug when pregnant?

Category C is the confusing category. A medication gets this classification if there is insufficient data on its use during pregnancy. It could be safe or probably safe, or it could be potentially harmful.

What are the 5 pregnancy risk Categories for drugs?

In 1979, the FDA established five letter risk categories – A, B, C, D or X – to indicate the potential of a drug to cause birth defects if used during pregnancy.

What are different schedules of drugs as per the D and C Act?

Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products. Schedule U: Contains various regulations and requirements for record keeping. Schedule W: Contains Generic Drugs List. Schedule Y: Contains requirement and guidelines for clinical trials.

What is a Category D drug?

Category D: Drugs in this class may be used in pregnancy if the benefits to the mother outweigh the risk to the fetus (i.e. a life threatening situation or a serious disease for which safer medication cannot be used or are not efficacious). Examples of medications in this class are phenytoin and valproic acid.

What is a Category B drug in pregnancy?

Category B drugs include prenatal vitamins, acetaminophen and several other medications used routinely and safely during pregnancy. If there is a clinical need for a Category B drug, it is considered safe to use it. Category C.

What is Schedule N drug?

Schedule N: Contains various regulations and requirements for a pharmacy. Schedule O: Contains various regulations and requirements for disinfectant fluids. Schedule P: Contains regulations regarding life period and storage of various drugs.

What is Schedule T?

Schedule T is defined as the schedule of drugs and cosmetic act & rules which represents the good manufacturing practice of asu (ayurvedic, siddha and unani) medicines along with area required for premises, specification required, qualification required, recommended machinery and equipment etc.

What is a Class C drug mean?

Class C. Class C drugs are considered by Parliament to be the least harmful of the controlled drugs. These include benzodiazepines, steroids and subutex (buprenorphine).

Is Category B safe during pregnancy?

Category B drugs include prenatal vitamins, acetaminophen and several other medications used routinely and safely during pregnancy. If there is a clinical need for a Category B drug, it is considered safe to use it.