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Prescription drugs have been a godsend for millions of people.

• Before insulin, diabetics would die, either from the direct effects of the disease or from complications like kidney damage and gangrene.
• Before penicillin and other antibiotics, people would die from minor bacterial infections or from the debilitating effects of syphilis and other sexually transmitted diseases.
• Before chemotherapy and similar drugs, the chance of survival for most forms of cancer was zero.

However, despite all of the good that prescription drugs have done, there are still instances where they have done as much harm as good.

How Drugs Make it to Market

Drug companies have to go through several phases before they can bring a drug to market – a process that can often take 12 years, or longer.

• In the first part of the process the drug company researches the possible uses of certain compounds for specific diseases. This process can take up to six years, depending on the compound and the disease they are trying to treat.
• In the second step of the process the drug company submits an Investigational New Drug Application to the FDA and conduct at least three phase of clinical testing.
  The first phase tests the overall safety of the new drug;
  The second phase tests safety and efficacy of specific doses of the drug;
  The third phase tests the safety and efficacy and evaluates the side effects.
  The clinical process can take up to six years, depending on the compound and the drug and the disease it I intended to treat.
• In the third step, the drug company submits a New Drug Application to the FDA, along with all of the reports from their pre-clinical and clinical testing, requesting approval to put the drug on the market. The FDA will then review all of the information, which could take as long as two years.

Once the drug reaches the market, the FDA also does surveillance on the drug to determine if it remains safe and effective once it is released to the public. The post-market surveillance period could last up to 14 years.

How Drugs Become Dangerous

Considering how long it takes, and how much testing is required, to bring a drug to market, it seems odd that any drugs would turn out to be dangerous. However, while the FDA approval process is quite involved, there are some work-arounds.

For example, if a new drug is based off another drug that was previously approved by the FDA, the pre-clinical and clinical testing phases could be significantly shorter than they would be for a completely new drug.

For example, the drug Levaquin is part of a family of antibiotics called fluoroquinolones — other antibiotics in this family include Avelox and Cipro. Levaquin is used to treat a variety of bacterial infections from bronchitis to anthrax. Levaquin is actually a second phase drug, meaning a first phase of antibiotics had already been made from fluoroquinolones and approved by the FDA. As a result, Levaquin might not have undergone as much testing as the first phase, because the two phases of drugs were so similar. Unfortunately, it was later discovered that patients were experiencing peripheral neuropathy (nerve damage) and tendon ruptures from using Levaquin. It resulted in many patients starting a Levaquin lawsuit because of the damage caused by the drug.

Fen-Pen is another example. Fen-Phen was a diet drug that was the focus of a lawsuit in the 1990s. It was a combination for two drugs that already existed on the market — fenfluramine and phentermine. Fen-Phen underwent some clinical testing, but because it was based on drugs that had already been approved, there might not been as much testing as if it were brand new. It wasn’t until the drug hit the market that people realized that the drug caused heart valve damage in 30 percent of patients.

Rushing through the testing process is not the only way drugs make it to market. There are also those manufacturers who simply bypass the FDA altogether and send their drugs straight to market. Not only are these drugs making it onto the shelves in drug stores, they are also making into the drug registries that doctors use to write prescriptions. The FDA estimates that approximately two percent of drugs fall into this category.

As a patient, you can protect yourself by reading the information that comes with your drug to keep yourself informed about the possible side effects and drug interactions. Pharmacists are often more up-to-date on medications, as well as possible side effects and complications, than your doctor, so if you have any concerns consult with your pharmacist first.

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