Zyprexa: FDA Related Information

Schizophrenia and mental illnesses are quite predominant nowadays. There are many treatments known to cure these illnesses and Zyprexa, which was once claimed to be a wonder drug, is administered for curing the same ailments. However, complications and severe side effects have been enough to brand it as a black box medication. Numerous claims and thousands of lawsuits filed against the makers, Eli Lilly, were adequate to bring to the notice of all the missing facts about this unsafe drug.

U.S. Food and Drug Administration (FDA), after they heard about a large number of claims, was forced to enter the picture and give strict instructions to the manufacturers to help settle the cases. First such event was issuing a warning letter in 2003, which linked the drug with serious complications like diabetes and elevated blood sugar levels among patients.

This notice was for Eli Lilly, demanding them to warn the healthcare experts and the patients about the potential side effects the drug caused. The warning also instructed doctors to monitor patients taking Zyprexa closely, especially when they have a history of diabetes, obesity or heart ailments in order to minimize any serious after effects.

Another step by FDA was taken in 2004, when it issued a ‘Dear Doctor’ letter to notify healthcare professionals to clearly monitor the effects of Zyprexa. It also demanded the makers to add a strict warning on their product sold as anti-psychotic drug, to help patients and doctors get fully aware about the complications involved before prescribing the drug. The letter also stated that deaths linked with increased blood sugar levels have been reported to be caused with Zyprexa and it was imperative for doctors to monitor patients after prescribing this drug in order to protect the suffering from fatalities.

The issuance of a black box warning was another step FDA took after considering the increased incidence of deaths in older people suffering from dementia. It had been found that patients who were prescribed Zyprexa were more prone to fatalities.

Meanwhile, there were around 8000 cases that were waiting settlement filed against Zyprexa. FDA demanded the makers of Zyprexa to not only settle all such cases with optimal monetary compensation but also to add to the label a new warning regarding the side effects the drug can have.

As per another report published, FDA was made aware about 19 cases of diabetes that were linked with Zyprexa. This side effect was observed to be caused in just one week after taking the drug. Out of the 19 patients, there was one who lost his life due to pancreatitis following increased blood sugar levels.

FDA after many such cases filed for not just against Zyprexa, but other drugs also, asked the manufacturers to include a black box warning on the labels on drugs that were linked with causing such severe complications among people.

The role FDA plays in drug approval in the US is supreme and no drug can be sold in the market without an approval from this agency. It’s important for FDA also to thoroughly inspect and study the drugs before an approval is issued to prevent unfortunate incidents due to harmful drugs.

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