Can Generic Drugs Be Dangerous?

In the last blog we discussed the possible problems that could develop from taking a generic medication. How often do serious problems or side effects occur because of the use of a generic instead of the brand name? Not often but sometimes even once is once to often.

A case to point is the action that the FDA took when it withdrew its approval for a generic version made by Teva Pharmaceuticals of the popular antidepressant Wellbutrin. The reason for withdrawing the approval for this generic version was that as it turned out this version was not bioequivalent to the brand name.

The FDA was forced to do testing on this particular generic version after it received numerous complaints from patients that Teva's version had made them feel woozy, sick to their stomach or even suicidal. It turned out that the generic's active ingredient dissolved four times more quickly in the first two hours that of the brand name because of a different time-release mechanism. In addition on average Teva's product achieved a concentration in the blood ranging from 40% to 75% of the brand name Wellbutrin.

At a meeting of the FDA's advisory committee for clinical pharmacology in 2011 a prominent physician presented evidence of three different generic formulations of levothyroxine. All three were more potent from the branded version and varied from one another. One was 12.5% above, another 9% above and the third 3% above.

Another problem with generics is that an estimated 80% of active ingredients and 40% of finished medications come from overseas. In some cases they are manufactured in facilities that have not yet been inspected by the FDA. Quality can be compromised. For example recently the maker of a generic Lipitor, Ranbaxy Pharmaceuticals, recalled 480,000 bottles after tin shards of glass were found inside the pills.

In 2012 Congress  passed the Generic Drug User Fee Ammendments bill. In it the generic drug industry agreed to pay the FDA  $200 million dollars a year over five years to speed up the review and approval of generic drug applications and increase inspections of generic manufacturing plants abroad. This is certainly a step in the right direction.

Nevertheless almost all of us are or will be taking some generic medications. It is important to pay attention to how we respond to the medication and to be aware of any unusual physical symptoms that we may develop while on the medication. Our health may depend on it.

Get more information in our book Live Longer Live Healthier

or visit our website at trienergetics.net

Are Generic Drugs The Same As The Brand Name

With the movement to curtail soaring healthcare costs, generic drugs have become increasingly popular. Many times we have no choice because many insurance plans will only pay for the generic. Other times we choose the generic because the price to us is better. In fact more than 80% of the drugs that we we take in the US are now generic, and this has saved Americans $193 billion dollars this past year.
                                                               
But are generic drug the same as the original? The answer in many cases is no. For example the FDA requires that the generic have the same bioequivalence as the brand name. but the standard is very broad and the concentration of the active ingredient in the blood is allowed to fall as much as 20% below or 25% above that of the brand name. If you look at the math you will see that the biological activity of the generic is allowed to vary by 45% from the brand name. This is further complicated by the fact that pharmacies shop generics by price. The pills that you get one month may not have the same biological activity as the pills that you got another month.

This could possibly mean that if the pills you took one month only met the minimum requirement and the refill that you took another month met the maximum limit you would have increased the amount of medication that you get in our body by as much as 45%. Worse than that you would have no way of knowing from the labels that you were not getting the same amount of medication.

In many cases these differences are not important, but they are critical for medications used to treat conditions in which blood levels must be kept in a narrow range. These medications include, thyroid, anti-seizure,  blood thinners, antidepressants, antipsychotics, asthma and immunosuppressants.

There is another important difference between the generic and the brand name. Although the generic must contain the same active ingredient as the original, the additional ingredients, known as excipients, can be different. These ingredients can effect the amount of the drug that is absorbed into the blood stream and can also be responsible for systemic side effects that do not occur with the brand name.

Get more information in our book Live Longer Live Healthier

or visit our website at trienergetics.net

How Good Are Generic Drugs?

About 3/4 of prescriptions in the U.S. are now generic drugs. This has made insurance companies happy because they are putting out more money. Should this make you happy? The FDA and most medical groups state that generics are as effective and safe as the original products. Generics must be equivalent to the original in terms of strength, quality, purity and safety. Generics must deliver the same amount of active ingredients at about the same rate as their brand name counterpart.

The generic can differ in shape, color and inactive ingredients. These subtle differences may be important especially with time release drugs. Overall the absorption of generics differs from the brand names by only 3 to 4%. These small differences will not matter for most drugs, but in some instances it may reduce effectiveness and safety.

If you switch from a brand name to a generic be alert for any change in your condition or for side effects. This is especially true if you are switched to a generic of a drug that must keep your blood level in a tight range.

If you have problems or side effects with any drug talk to your health care provider.

Get more information in our book Live Longer Live Healthier

or visit our website at trienergetics.net