Center for Devices and Radiological Health division of FDA

Oct 24, 2018 | 0 comments

Oct 24, 2018 | Miscellaneous | 0 comments

Center for Devices and Radiological Health division of FDA

Food and Drugs Act agency oversees the implementation of rules and regulations governing the safety, efficiency and quality of drugs and food products sold to consumers. The agency has the mandate to authorize or terminate production depending on the requirements outlined in the legislation. The Center for Devices and Radiological Health which is an FDA division ensures that drugs are suitable for human consumption and that medical devices used in treatment and research does not produce harmful gases that endanger human life as indicated by Law (2005). The agency through CDRH has been able to withdraw a number of devices and drugs that were introduced into the market but later were realized to be detrimental to human health to ensure the safety of prescribed drugs. This paper discuss the recall of tetrazepam drug pointing out its use and it is negative impact that resulted to its withdrawal.

Pirker, Misic, Brinkmeier & Frosch (2002) claims that Tetrazepum is a drug that was originally used in countries such as Australia as a muscle relaxer to treat muscle spasm and in treating anxiety disorders such as panic attacks since it contains relaxation properties. Moreover, the drug is used in the treatment of acute alcohol withdrawal symptoms such as hallucinations. In combination with other medication, it can be used to treat convulsive disorders. Although not recommended, some people use it to ease depression. The drug can be found in both liquid and solid form (pills) and exists under several brand names which include Clinoxan, Epispasm. Relaxam, Spasmorelax, Myolastan and Musaril.

Tetrazepam had already been introduced into the European Union market but with time through clinical research, it was realized to be extremely toxic with continuous use. For instance, exposure to tetrazepam resulted to hypertensive reactions as it was found to be an allergen resulting to skin allergies causing a rash. It was found to be extremely dangerous for children thus posed a created threat to children’s lives considering their experimental nature. In addition, it has withdrawal symptoms like muscle cramps and convulsion indicating that it is addictive in the long run thus harmful as stated by Randallc (2011).

Furthermore, Organization (2013) says that tetrazepam has other dangerous side effects like unnecessary exhaustion, unsteadiness as well as drowsiness. Others include depression, lightheadedness, blurred vision and nausea. The fact that some of the symptoms it was supposed to treat were attributed to its side effects such as hallucination, insomnia, anxiety and increased muscle spasticity proved that the drug was in reality causing more harm than good.

The discovery of these harmful side effects of tetrapezam to human health to lead to its retraction of all medicines that it was contained in from the market consequently prohibiting its manufacturing. It was realized that its overall impact are despicable as it possesses a created threat to human existence from infants to adults with its usefulness being almost non-existing suggesting that failure in serving its indented purpose as implied by Schellander & Donnerer (2010). The removal of the drug was a great relief to the public as it minimized incidences of its side effects thus promoting a healthy population.

In conclusion, evaluation of drugs through clinical research helps keep track of new drugs introduced into the market to ensure their long-term efficiency and suitability in promoting human health; of which if ineffective, then it is banned from the market by Center for devices and radiological health.

References

Campbell, G.(2005). The experience in the FDA’S Center for Devices and Radiological Health with Gayesian strategies. Clinical Trials.doi:10.1191/1740774505cn093oa

Law, M. T. (2005). How do Regulators Regulate? Enforcement of the Pure Food and Drug Act, 1907-38. Journal of Law Economics & Organization.doi:10.1093/jleo/ewj014

Libecap, G.D., & Law , M.T.(2003). Corruption and Reform? The Emergence of the 1906 Pure Food and Drug Act and the 1906 Meat Inspection Act.

Mine, C. (2000). The Food and Drug Administration Modernization ACT and the Food and Drug Administration: Metamorphosis or Makeover? Drug Information Journal.doi:10.1177/009286150003400304

Organization, W.H. (2013). WHO Drug Information Vol. 27 No. 2 2013. Geneva: World Health Organization.

Philipson, T.J., & Sun, E. (2008). Is the Food and Drug Administration Safe and Effective? Journal of Economic Perspectives.doi:10.1257/jep.22.1.85

Pirker, C., Misic, A., Brinkmeier, T., & Frosch, P.J. (2002). Tetrazepam drug sensitivity-usefulness of the patch test. Contact Dermatitis. doi:10.1034/j.1600-0536.2002.470302.x

Randallc, B.A.(2011). Disposition of toxic drugs and chemicals in human. S.I.: Biomedical Publishers.

Schellander, R., & Donnerer, J. (2010). Antidepressants: Clinically Relevant Drug Interactions to Be Considered. Pharmacology.doi:10.1159/000319744

Thompson, J. (2006). Effect of the federal food and drugs act on the wholesale drug business. Journal of The American Pharmaceutical Association. doi:10.1002/jps.3080020216