This has been a week of safety oriented blog posts. Today’s subject is Phenylpropanolamine (PPA).

October 10th, 2008

Most authors receive emails daily with requests to include information in their blog posts. Most offer a level of education. Some are more useful than others. This one scared this author more than a little.

Most authors receive emails daily with requests to include information in their blog posts. Most offer a level of education. Some are more useful than others. This one scared this author more than a little.

The following posts this week all relate to safety issues.

1. Food Safety in North America requires a ZERO TOLERANCE policy by all safety and health related organizations

2. Let’s review a good idea from China and build on the traceability discussion

3. Understanding E.coli and limiting its spread.

Now we need to add the following and it is important that you pay close attention. During 2005 which in this case is almost three years ago the FDA announced the following.

Update – On December 22, 2005 the FDA issued a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control products containing phenylpropanoloamine preparations. This proposed rule reclassifies phenylpropanolamine as nonmonograph (Category II) not generally recognized as safe and effective. Written and electronic comments and new data can be submitted by March, 22, 2006.

The email I received today contained the following sad story and guidance. The authors name is being withheld.

I would like to thank those of you who expressed condolences on the recent passing of my mother. She suffered a hemorrhagic stroke while she was driving home from my house on 7/30 and passed away on 8/3. My mother’s stroke and passing was an enormous shock to my family because she did not have any symptoms or risk factors for a stroke. Just the week before she had gone to her doctor for a check up and received a clean bill of health. She did, however, develop a cold while she was visiting me and had taken Alka Seltzer Cold Plus for 3 days. Since her passing, we have learned that Alka Seltzer is one of the many cold medicines that contains Phenylpropanolamine (PPA) which can cause hemorrhagic stokes or cerebral bleeding even with the first use. I am forwarding a list of other medications that currently use PPA. These medicines are supposedly being recalled but my mother just purchased this medication less than two weeks ago. Pharmaceutical companies have known about this danger for years, we unfortunately, did not.

For those not aware of PPA, there are literally dozens of products that contain it. This author is not sure why products containing PPA have not been recalled but offers the following guidance. Procurement professionals should be aware of PPA and carefully look at the ingredients contained in all over the counter products prior to buying them for resale. Obviously consumers should also review the ingredients and if you have questions ask your retail pharmacist for guidance before you buy.

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