Pharm Fresh Loops

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Since January of this year 25 drugs have been recalled by a number of big pharm companies. A nice long list of recalls found on the FDA’s website tells us of a litany of bad drugs from IV solutions to eye drops. At the top before the exposure of them ta disclaimer is given..

“NOTE: The recalls on the list are generally Class I., which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Many have been found to have trace particles in different introvenous drugs such as Cubicin (used to treat skin infections), glass particles were found in that specific drug. Others such as a Liquid Bicarbonate Concentrate used for hemodialysis had bacterial contamination that has already caused two cases of death. Visible particles were in a majority of these recalls, other reasons include unknown ingredients, potential health risks, and bacterial presence.

Don’t you think they should have already taken care of these problems before releasing them onto the public?
If they have “tested” and “approved” these drugs already there shouldn’t be a reason for recall. What do the companies do to be able to surpass the FDA and put their product on the market even if there’s known or unknown problems?

Well the FDA approves almost all pharmaceuticals before being put onto market, however there are some that are unapproved and illegally on the market. After 1962, some companies were not required to fill out a New Drug Application or and Abbreviated New Drug application due to pre-approved circumstances before 1962. The FDA created DESI (Drug Efficacy Study Implementation) that year to be sure that the drugs were safe and labeled as such. Since, some were already pre-approved as “safe” by the FDA there wasn’t a reason for those companies to fill out an NDA or ANDA. The loopholes are that if a drug was unapproved in one form by the FDA, there still may be an ingredient that was approved and still able to be used in compounding new drugs; compounding can be done anywhere from hospitals to nuclear pharma locations. Technically, all compounded drugs are illegal and still being distributed carefully to the public. Therefore, these specific drugs are on the market illegally and are still being prescribed to the people today. Considering these companies don’t label the drug as “FDA Approved” either some healthcare providers are blissfully ignorant of the unapproved drugs, hence the continuing of the prescriptions.

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Pharmaceutical companies, in my opinion, are some of the most corrupt in our society today, next to big food industries and the music industry. It has been 7 months since I have been on any form of pharmaceutical drug and its benefits are noticeable in my life. I have a bit of a tangent on big pharma which I’ll post after this one.

ALL OF THIS INFORMATION CAME STRAIGHT OFF THE FDA.GOV WEBSITE.

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