Month: June 2011

Note: This post comes from one of our favorite readers (he has requested to remain anonymous), who has also contributed posts in the past about FDA issues:

 

The FDA’s oversight of drugs that have not been evaluated for safety and efficacy in their prescribed formulations and are thought to pose (potential) hazards has been summarized in previous blogs. On May 25, 2011, the FDA recalled drugs from a manufacturer (Regrowth, LLC) selling products online. This action was taken due to their status as “unapproved drugs (that) may present potential health hazards” (see

FDA.gov

).

While the recall is for the manufacturer and not users of the drug(s), and it appears that no serious adverse effects have been listed, users should also be aware of the FDA’s action and the caution that other unproven products are sold online with unstudied risk/benefit profiles. The failure to recall these other products and stop their sale is less likely an acceptance of their appropriateness and more likely a reflection of the FDA as a underresourced regulatory agency that has to devote their time to many priorities. Although any given person may benefit from such products, the actual degree of benefit and short-and long-term risks, is unknown (i.e. ‘Buyer Beware’). It is also noteworthy that the drugs sold by Regrowth, LLC -as with many online ventures -were being distributed on a massive scale (to individuals in over 70 countries or regions).

Below is taken from the FDA website and verbatim language of this public notification:

PRODUCT

1. Retinoic Acid 0.025% (containing 0.025% Retin-A) Topical solution, 60 mL bottle, Recall # D-513-2011;
2. Retinoic Acid 0.05% (Containing 0.05% Retin-A) Topical solution, 60 mL bottle, Recall # D-514-2011;
3. 2% Spironolactone Topical Solution, 60 mL bottle, Rx. Recall # D-515-2011;
4. 5% Spironolactone Lotion, 2 oz jar, Rx. Recall # D-516-2011;
5. Treatment Shampoo (2% Ketoconazole and 3% Salicylic Acid) Topical Solution, 4 oz bottle, Rx. D-517-2011;
6. Minoxidil 5% Topical Solution, 65 ml bottle, Rx. Recall # D-518-2011;
7. Minoxidil 5% with 0.025% Retinoic Acid Topical Solution, 65 mL bottle, Rx. Recall # D-519-2011;
8. Minoxidil 5% Topical Solution without Propylene Glycol, 65 mL bottle, Rx. Recall # D-520-2011;
9. Xandrox (5% Topical Minoxidil Azelaic Acid Solution), Day Time Formulation, 65 ml bottle, Rx. Recall # D-521-2011;
10. Xandrox with .025 Retinoic Acid (5% Topical Minoxidil Azelaic Acid) Solution, Nigh Time formulation, 65 ml bottle, Rx. Recall # D-522-2011;
11. Xandrox without Propylene Glycol (5% Minoxidil Azelaic Acid) Solution, 65 ml bottle, Rx. Recall # D-523-2011;
12. 12.5% Minoxidil Solution, 125 mL bottle, Rx. Recall # D-524-2011;
13. 6% Minoxidil Plus Solution, 65 ml bottle, Rx. Recall D-525-2011;
14. Xandrox Medicated Lotion (12.5% Minoxidil and 5% Azelaic Acid), 30 mL and 125 mL bottle, Rx. Recall # D-526-2011;
15. Xandrox 15 (15% Minoxidil and 5% Azelaic Acid) Solution, 125 mL bottle. Recall # D-527-2011;
16. Xandrox 15-Plus (15% Minoxidil, 5% Azelaic Acid and 0.1% Finasteride) Solution, 125 mL bottle. Recall # D-528-2011

CODE
All lots

RECALLING FIRM/MANUFACTURER
Regrowth, LLC, Whittier, CA, by letters on March 29, 2011. FDA initiated recall is ongoing.

REASON
Marketed Without an Approved NDA/ANDA: These products are unapproved drugs and may present potential health hazards.

VOLUME OF PRODUCT IN COMMERCE
57,999 bottles

DISTRIBUTION
Nationwide, Argentina France Malta South Africa Australia Germany Mauritius South Korea Austria Greece Mexico Spain Azerbaijan Guam Netherlands Sweden Bahrain Hong Kong New Zealand Switzerland Belgium Hungary Northern Ireland Taiwan Bolivia Iceland Norway Thailand Brazil Indonesia Peru Trinidad Bulgaria Ireland Philippines Turkey Canada Israel Poland UAE China Italy Portugal Ukraine Colombia Japan Puerto Rico United Kingdom Croatia Jordan Qatar Uruguay Cyprus Kuwait Republic of Georgia Vietnam Czech Republic Latvia Romania Yugoslavia Denmark Lebanon Russia Ecuador Lithuania Scotland Estonia Macau Serbia Faroe Islands Malaysia Singapore Finland Maldives Slovenia

I just turned 20 and since a month before i turned 18 year old, i started to shed hair. Yes my uncle and father have lost hair, but with receding hair lines. For these 2.5 years, my hair has gotten thinner with no visible bald spots on my crown and no receding hair line.

My dermatologist prescribed me with extina foam and clobex lotion which indeed seem to cause my scalp to thin even more and a visible spot from the front of my hair line to the back of my crown. My question is, is this worsening of hair loss the result of these medical tools or was this inevitable? Mind you just a few months back in Febuaray i had no visible spots on my scalp. Info would be great in searching for an answer.

It is interesting that you can pinpoint the exact timing of when your hair loss started. If you indeed have genetic male pattern baldness, you simply can’t completely stop the progressive nature of the process. Medications may be used to slow it down and surgery may be used to add hair, but nothing will reverse the time factor.

The only FDA approved and clinically proven treatments are Rogaine (minoxidil) and Propecia (finasteride). Extina Foam is ketoconazole, and while there may be some anecdotal evidence that ketoconazole helps with treating hair loss, it hasn’t been FDA approved as such. Clobex is a powerful steroid, so I would expect that it might just hasten the hair loss process, just as we see with oral steroids. I understand there are thousands of treatment products and the option to use them is you and your doctor’s prerogative to try.

Snippet from the article:

A class of drugs meant to improve symptoms of an enlarged prostate gland actually increase the chance of getting a more serious form of prostate cancer, health officials said on Thursday. However, they also said the drugs’ benefits outweigh the risks.

The drugs in this group include Merck & Co’s Proscar and GlaxoSmithKline’s Avodar and Jalyn, as well as Merck’s Propecia, which is approved to treat male pattern hair loss.

The Food and Drug Administration said it revised the labels on all such drugs, called 5-alpha reductase inhibitors (5-ARI), to include the risk after reviewing two large studies.

Read the rest — Prostate drugs raise risk of prostate cancer: FDA

Today comes news that the FDA is warning that drugs like Avodart and Proscar may increase the risks of some forms of prostate cancer.

In the original studies, the overall incidence of prostate cancer in the thousands of individuals enrolled in a double blind FDA sponsored activity showed that overall risks of cancer in those men treated with 5mg finasteride (Proscar) saw a 25% decrease in risk of developing prostate cancer. After the study was published, pathologists looked at the types of cancer that they saw, and reported that of those fewer men that did develop prostate cancer, the presence of more aggressive cancers was greater in that group.

These risks are very small and the overall reduction of prostate cancer standing at 25% in the 7 year trial should offset the other risks of a more aggressive cancer, but the statistics on this are dubious at best. For those men who are taking finasteride (at any dose), they must recognize that there is a risk of a more aggressive prostate cancer, no matter how small that risk is.

The information about cancer reflects the experience with finasteride 5mg (Proscar), not 1mg for treating hair loss (Propecia). What we do not know is the threat of the 1mg dose, if any. There have been no reports that separate the 5mg and the 1mg dose in the cancer risk scenario.