In the year 1906, the US congress passed laws to safeguard consumers’ against harmful and ineffective food and drug products. This was among the first 200 most comprehensive and effective laws passed world wide in this perspective. In the year 1938 the Act was amended to include cosmetics after a toxic elixir killed 107 people. This has evolved over the years to include the requirement for manufacturers to provide safety information on their products for the well being of the consumer.
The Food And Drug Administration (FDA) has been criticised and praised at the same time for it’s cautious oversight of dugs and pharmaceuticals. With that in mind, We’ve decided to bring you a comprehensive list of 5 of the biggest FDA’s drug recalls, rejections and warnings.
What Makes a Drug Qualify for an FDA Recall?
For a product to qualify for an FDA recall, it is required to have posed a threat to the consumer. The consumer in this regard may have noted effects that are deemed to have unwarranted effects from use of the product. The consumer may in this regard contact the local FDA office from where the recall process is initiated. The manufacturer may also note a defect with the product after it has already been circulated in the market. The manufacturer will in this respect contact the FDA offices from where a recall notice will be issued. The product will therefore qualify for a FDA recall if it is deemed to pose a threat to the consumer.
FDA Recall Notice
When a recall is being done, due process requires to be followed. This includes providing adequate information in regard to product identification. The information required for this purpose includes the lot numbers, expiry dates, serial and catalogue numbers as well as model numbers. A copy of the product label is also attached to the FDA recall notice which is essential to ease identification of the product by distributers and wholesalers.
Extent of FDA Recall
When an FDA recall is being conducted, there is need to indentify the extent of the recall. This identifies the level at which the recall is being conducted. This can be either at wholesale, retail or at user level. The recall notice clearly states the extent of the recall e.g. “this recall is to the retail level.” However where distribution of the product has surpassed the level of recall a sub recall is issued. This instructs the wholesalers to recall products that they may have shipped to consumers and that which falls within the prescribed criteria.
Passing Information on FDA Recall
FDA recalls targets consumer products which are deemed to pose a threat to the users. This calls for caution so as not to raise false alarms to the users. In case of drug recalls, the physicians who might have used the drug on patients are advised accordingly so that they can provide essential preventive measures on patients who may be affected by the drug. This includes evaluation of the patient as well as necessary patient care. Store owners also need to be informed accordingly so that they can help identify the products as displayed on their shelves. They may also give essential information regarding the stock which might be held in their back rooms and that which is transit to various consumers.
FDA Recall Evaluation
When a product has been identified for FDA recall and necessary information has been passed on, there is need to have an evaluation which will give an overall insight on the level of success of the recall. It is also essential in indentifying if full information regarding the recalled product was received and understood correctly. In instances where this has not been achieved, the notification is resent where it indentifies the recalled product in better details and as well the modality of dispatching the information enhanced. This is done through a document provided by the district recall coordinator.
FDA Recall Firms
In various instances manufacturers will not have sufficient manpower and systems to conduct a recall for a defective product. It is in this respect that they engage recall firms which are empowered and have the capacity to conduct the process. They undertake the whole process in conjunction with regional FDA recall offices.
FDA Recall Status Reports and Termination
During the process of FDA recall, updated reports on the effectiveness of the notices issued and the rate of product return. Where this has been effective, the company undertaking the process may call for termination of the process. This may be occasioned by a full return of the defective products. However, the final termination notice is given by the FDA office upon submission by the district recall coordinator on the success of the process.
5 Bggest FDA Recalls, Rejections and Warnings Of Dangerous Drugs
FDA Recall Case 5 – Fen-Phen
The weight-loss drug Fen-Phen was recalled by the FDA in 1997 after several consistent reports of cardiovascular problems such as primary pulmonary hypertension. Fen-Phen was a popular and widely used diet drug throughout its time Lasting 24 years on the market before it was eventually recalled bu the FDA making it one of those historic recalls in history.
FDA Recall Case 4 – Meridia
Meridia is a a weight-loss drug approved in 1997 just like Fen Phen, but was later recalled in October of 2010 by the FDA after a series of reports and studies linked it to cardiovascular problems. It was discovered that the drug increases chances of stroke, heart attack, cardiac arrest or cardiac death by 16 percent according to a recent report published by The New England Journal Of Medicine. The Medical Journal referred to Meridia as “another flawed diet pill.”
FDA Recall Case 3 – Avandia
This is a diabetes-drug that was introduced in 1999 as a way to regulate blood sugar in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin, quickly became one of the best-selling diabetes pills in the world. In 2007 researchers linked the drug with heart problems. It has been banned in the European Union and heavily restricted in the U.S.
FDA Recall Case 2 – Vioxx
This is one of the largest and most controversial in the history of the FDA since the drug was approved in 1999, Vioxx was withdrawn from the U.S. market in 2004. The withdrawal was due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx. The Wall Street Journal in 2004 citing an unreleased government document, reported that Vioxx was responsible for an estimated 27,000 heart attacks and cardiac deaths.
FDA Recall Case 1 – ‘Female Viagra’ (Flibanserin)
The too good to be true Women’s ‘pink pill’ counterpart to the men’s ‘little blue pill’ Flibanserin was a novel, non-hormonal treatment for pre-menopausal women with Hypoactive Sexual Desire Disorder(HSDD), simply put, the drug was designed to increase sexual drive in women, vut the development was terminated was terminated in October 2010 following a negative report by the U.S. Food and Drug Administration, FDA found out that its benefits were not substantial enough to outweigh its side effects. The drug’s side effects included fatigue, depression and fainting spells.