Drug withdrawal from market

Reasons for Drug Failure in Clinical Development/Withdrawal from Market Places... 

Drug Withdrawals From the Market - Causes and Consequences... 

CH44 DRUG WITHDRAWALS FROM THE MARKET - CAUSES AND CONSEQUENCES... 

Supporting this conclusion is the fact that approval times have decreased from 27 to 14 months. However, the GAO also reported a small increase in the drug-withdrawal rate since the implementation of PDUFA. That is, a higher percent of approved drugs has been withdrawn from the market because of safety issues. FDA officials argue that the increase is insignificant - from 3.10% in the 8-year period before PDUFA to 3.47% in the 8-year period after. 

Practolol (Figure 8.13) was the prototype cardioselective p-adrenoceptor blocking agent. Selectivity was achieved by substitution in the para position with an acetyl anilino function. The similarity of this drug with those outlined above is obvious. Practolol caused severe skin and eye lesions in some patients which led to its withdrawal from the market [6]. These lesions manifested as a rash, hyperkeratosis, scarring, even perforation of the cornea and development of a fibrovascular mass in the conjunctiva, and sclerosing peritonitis. Some evidence is available that the drug is oxidatively metabolized to a reactive product that binds irreversibly to tissue pro-... 

It would be useful for pharmaceutical physicians to have some examples of medical products that have been the subject of serious adverse reactions requiring regulatory action. In the following subsections a number of products have been selected that illustrate different drug safety problems. Major attention has been paid to psychotropic agents because they are widely used and have been the subject of regulatory evaluation and action over the past several years which has resulted in restrictions to use and in some cases withdrawal from the market. 

The first major new drug to be approved and withdrawn from the market by the CSD was ibufenac, the first of the non-steroidal antiinflammatory drugs (NSAID) to be marketed. Ibufenac was a precursor of ibuprofen and its use in the United Kingdom was associated with serious and frequent hepatotoxicity. Two other drug withdrawals (also approved during their tenure by CSD) were chlormadinone and fenclozic acid. 

Drug adverse events will always remain part of modern medicine and the potential for another thalidomide disaster cannot be totally dismissed. The prevention of a future disaster lies, not in simply increasing the number of regulatory hurdles but in the ability to communicate and control unexpected events and where necessary make rapid withdrawal from the market. 

August 8 Bayer withdraws its statin drug Baycol from the market after analysis of new data shows that 31 patients taking the drug had died from rhabdomyolysis, a rare disease that destroys muscle tissue. 

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