US FDA ordered to halt marketing of unapproved single-ingredient oral dosage form drugs containing colchicine as an active ingredient, these drugs are commonly used in prevention of gout and acute gout flare ups , and for treatment of Familial Mediterranean Fever (FMF).
The companies manufacturing oral dosage form drugs containing colchicine are asked by US FDA to stop manufacturing of these drugs within 45 days and they are required to stop shipping these unapproved product within 90 days.
These drugs are said to be unapproved, as these drugs are not proved to be complying with requirement of modern requirements of US FDA for being declared as safe and effective drugs.
US FDA took this action as these drugs containing colchicines which is much toxic, the dosage at which these unapproved drugs are prescribed are very near to the toxic dose. Also neither any of these drugs are studied for safety and efficacy with respect to minimum effective and safe dose for the indications these drugs were being marketed (clinical trials).
Where as the only approved drug Colcrys that contains single ingredient colchicines is approved by US FDA with respect to modern safety and efficacy requirements of US FDA , also the manufacturer of Colcys has provided data that, even at a lower dosage of colchicines for the given indications it is much effective and safe than the regular higher dose earlier being prescribed. Unapproved versions of colchicine are not generic drugs.
The dosages at which these unapproved drugs are proscribed have no proof or evidence to establish that the strength of dosage is safe and effective.
US FDA has already asked companies to stop manufacturing and marketing of unapproved injectable dosage form containing colchicine in way back in 2008, as 23 deaths were reported following administration of injectable dosage form of colchicine,a drug with a narrow therapeutic dose and toxic dose range, also fatal adverse effects like low blood cell counts, cardiac events, and organ failure were reported.
Why there are some drugs said to be unapproved and are there available in market.
Many of these unapproved drugs are older products introduced well before formation of FFDCA in 1938 these drug products were approved on the basis of 1906 Pure Food and Drug Act, that required a drug for getting an approval only to comply with some standards of strength and purity and not for safety.
Also earlier in 1960’s drugs were given approval based on only aspects of safety and efficacy , but safety study like clinical trials for safety were not under control by FDA, until the heroic rejection of drug containing thalidomide in 1960 by Madam Dr Frances Oldham Kelsey an US FDA employee then. Her decision actually saved millions of American children's from disabilities,which forced US legislation to pass an act to provide an additional authority to FDA to make it mandatory for a drug to be proved that it is a safe by conducting clinical trials which are completely assessed by US FDA to get an approval for marketing a drug in USA.
There are three types of unapproved drugs
A.DESI Drugs
DESI means Drug Efficacy Study Implementation
Refers to a drug that is a subject of 1938-1962 NDAs (safety only) and drug which is identical, related, and similar to such drugs.
DESI drugs are not “grandfathered” or generally recognized as safe and effective (GRAS/E)
B.Prescription “Wrap-Up”
Refers to drugs that are on the market based on a claim of being a pre-’38 or pre-’62 product or identical, related, or similar to such a product
C.Post ’62 Drugs
Drugs initially marketed after 1962
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