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Articles Tagged with FDA

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Recently, the U.S. Food and Drug Administration sent a not-so-friendly letter to to a drug manufacturer concerning a certain reality star’s social media post about a medication she is allegedly taking to help her deal with morning sickness during her pregnancy.

While it may seem like just another nugget of celebrity gossip, the FDA’s letter is important because it brings to light the influence that so-called “celebrity endorsers” can have on their massive fan base.  The FDA calls the celebrity endorsers and the drugs’ manufacturers to task for not mentioning drug side effects as required by federal law.

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2015-05-01 15.52.57For people who take a medication, the warnings that comes along with it are the most important protection they have from harmful side effects. New information emerges every day about drugs and its potential side effects. Under the current Food and Drug Administration regulations, getting a proper warning included with drug information is harder than it should be for makers of generic drugs, and the Food and Drug Administration is considering steps to fix that.

Since November 2013, the FDA has been considering new rules for generic drugs that would allow manufacturers to expedite the process of revising labels to add warnings or information that is critical for consumers taking these drugs. This can include updating dosage amounts, safety and efficacy information.

Under the current rules, generic drug manufacturers must follow the warning labels provided by the brand name drug.  The proposed changes would allow generic drug manufacturers to change the warning labels on drugs if new information is discovered regarding dangerous side effects of the drug.

The FDA plan is called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. The FDA recently accepted public comments about this change and held a public hearing on it. The American Association for Justice supports this change to allow generic drug manufacturers to update information packaged with their products. AAJ’s comments to FDA are available here.

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shots with bottlesEarlier this week, the Food and Drug Administration announced it is requiring the manufacturers of low testosterone drugs to change the labels of their products and to conduct further studies about the drugs. The FDA says some studies have indicated there is an increased risk of heart attack, stroke and even death while taking supplemental testosterone, while other studies have not. This has led the FDA to say that more research is needed by the manufacturers of the drugs as well as to require more warning labels on Low Testosterone drugs to better prepare doctors and patients for discussions about taking “Low T” drugs.

The FDA specifically called out clinics offering to treat the “signs of aging” in men which are often believed to be linked to gradually decreasing testosterone in the body. While decreasing testosterone may seem to be the culprit of fatigue or other similar problems, there’s not been enough research of the side effects of taking Low T drugs simply to fight the signs of aging. The FDA says the drugs should only be used in men who are suffering from low testosterone as a result of “disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.”

Health care providers should make patients aware of the risk of possible cardiovascular events and even death due to taking testosterone, the FDA says.

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