FDA Finds Faked Documentation At Cetero

This is a really good example of how improper documentation practices can get a company into real trouble.

Read this Reuter's release, FDA finds drug research firm faked samples, documents.

In a nutshell:

"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.

FDA Warning - Anesthetics On Skin Can Harm

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Updated October 6, 2022

The link in the original post broke.

You can still read about this topic here:

FDA Issues Public Health Advisory Alert on Skin Numbing Products - OH&S Online

---  the original post follows below  ---

According to the FDA press release, FDA Alerts Public about Danger of Skin Numbing Products, popular topical anesthetics (that is, skin numbing drugs) can cause severe reactions when used improperly. The alert talks about serious and life-threatening risks associated with improper use of topical anesthetics available in over-the-counter (OTC) and prescription forms of these drugs. These skin-numbing products in cremes, ointments or gels contain anesthetic drugs such as lidocaine, tetracaine, benzocaine, and prilocaine that are used to desensitize nerve endings near the skin's surface. If used improperly, the drugs can be absorbed into the bloodstream and cause reactions such as irregular heartbeat, seizures, breathing difficulties, coma or even death. Here are some details you should read . . .

The FDA strongly advises consumers not to:

• make heavy application of topical anesthetic products over large areas of skin
• use formulations that are stronger or more concentrated than necessary
• apply these products to irritated or broken skin
• wrap the treated skin with plastic wrap or other dressings
• apply heat from a heating pad to skin treated with these products.

If a health professional recommends the use of a topical anesthetic, then:

• use a topical anesthetic that contains the lowest strength, and amount, of medication that will relieve the pain
• apply the topical anesthetic sparingly and only to the area where pain exists or is expected to occur
• do not apply the topical anesthetic to broken or irritated skin
• ask your healthcare professional what side effects are possible and how to lower the chance of having life-threatening side effects from anesthetic drugs
• be aware that wrapping or covering the skin treated with topical anesthetics with any type of material or dressing can increase the chance of serious side effects, as can applying heat to the treated area while the medication is still present

Did you learn anything new here? What are you going to do differently for yourself, or for your loved ones for safety's sake? 

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