The Importance of FDA-Approved Hair Products
We've all seen the term "FDA-Approved." But, do you know what it means? The United States Food and Drug Administration (FDA) is a federal government agency in charge of keeping the American public safe by regulating food, drugs, and medical devices. When a product or item is FDA-Approved, it has been rigorously tested and thoroughly inspected, and found to be both effective and completely safe for people to use or consume.
So, how does this relate to your hair?
Well, if you are experiencing hair loss, interested in hair restoration, or just curious about the process, you will undoubtedly encounter a wide variety of products to help stimulate hair growth. Many of these products are not FDA-Approved, which should be an automatic red flag. In other words, if a product is advertised to treat a medical condition, such as hair loss, but it does not indicate anywhere that it is FDA-Approved, then you should avoid using that product. You may be taking a major health risk using a product that is not FDA-Approved to treat any medical condition.
Avacor Physician's Formulation® is an FDA-Approved hair restoration product clinically proven to revitalize hair follicles and help you grow back your very own hair. The FDA has carefully tested and inspected how the product is manufactured, what ingredients are used, how much of each ingredient is used, how the product is stored and packaged, and how the product is administered. In other words, all aspects of Avacor Physician's Formulation production, including each ingredient, the bottling process, and the recommended dosage, have been deemed completely safe and effective for consumers to use for the treatment of hair loss, according to the FDA.
Unfortunately, some consumers continue to be tricked into buying "snake oil" products, or hair loss treatments not approved by the FDA. These products can cause unhealthy and unwanted side effects, such as acne, scalp hair loss, menstrual irregularities in women, irritability, and aggression, according to Dr. Ray Sahelian. The FDA also indicates other side effects of hair growth products that are not FDA-Approved include low blood pressure, heart palpitations and other cardiac symptoms, hair discoloration, sensitivity to sunburn, itching, rash, irritation, or stinging skin. "Snake oil" products are a waste of time and money. They also taint consumer's opinions of the entire industry, making consumers skeptical of all hair loss products, including the legitimate ones. Additionally, they can add more emotional stress in your life when you buy the product and it doesn’t work, and/or causes health problems.
The good news is that the FDA is starting to crack down more on snake oil salesmen and punishing people with fines and/or jail time for trying to sell hair regrowth products to consumers that are not FDA-Approved. However, consumers still need to be aware of the product they are buying.
The active ingredient found in Avacor Physician's Formulation is Minoxidil. Currently, the FDA has approved Minoxidil in two different strengths: 5% for men and 2% for women. The Avacor product has Minoxidil levels that adhere to these requirements. If the levels were anything different than the 2% and 5% required by the FDA, the product could not be advertised as FDA-Approved, and could be recalled by the FDA at anytime.
In January of 2012, the FDA issued a press release announcing the recall of some hair regrowth products because they were unapproved new drugs, and had high levels of Minoxidil that could cause health hazards to consumers. These products had Minoxidil levels between 10 and 15%. If you are currently using a hair regrowth product, be sure to check the Minoxidil level, and consider switching to Avacor's FDA-Approved Physician's Formulation, as well as other hair care products: the Avacor® All Natural Nutricap containing the active ingredient Saw Palmetto, which is widely thought to be a DHT inhibitor; Boost! by Avacor®, which is specially formulated to thicken hair from the very first application; and our Scalp Detoxifying Shampoo, which removes dirt and oil from the scalp, ensuring effective delivery of the Minoxidil to the scalp when applied after using the shampoo. Rest assured that all our products are manufactured in facilities that meet the highest safety and quality standards today. Furthermore, all our products are safe to use, and have been formulated to either help you grow a natural, full, healthy head of hair, or to maintain healthy, clean, and stylish hair.
Minoxidil Mini-Series: Part 4 – FDA Approval and Transition to OTC
So far in the Avacor® Hair Regrowth Blog’s “Minoxidil Mini-Series,” we have documented the initial use of minoxidil as a blood pressure medication, the surprising discovery that it regrew hair in patients with androgenetic alopecia, and the clinical trials that eventually proved minoxidil’s effectiveness for treating hair loss.
Today the story continues with the Food and Drug Administration’s initial approval of 2% minoxidil for male pattern baldness in 1988, supplemental approvals allowing use by women and availability over-the-counter, and finally the approval of 5% minoxidil (extra-strength) for men in 1997.
FDA Approves Minoxidil for Male and Female Pattern Hair Loss
After the efficacy of minoxidil for treating hair loss was demonstrated in clinical trials (see our last post for a summary), Pharmacia & Upjohn submitted a New Drug Application (NDA) to the FDA seeking approval to market a 2% topical minoxidil solution for male pattern hair loss.
NDA 19-501 for “Rogaine® Topical Solution” presented data on the safety and efficacy of the formulation, pharmacokinetic studies of drug absorption, a statistical review of the clinical results, and proposed package labeling for the product. With its approval on August 17, 1988, minoxidil became the first-ever FDA-approved treatment for hair regrowth.
Soon after, a supplemental application was made for the use of 2% minoxidil by women suffering from female androgenetic alopecia. Supported by several clinical trials that showed the effectiveness of minoxidil for treating hair loss in women (also summarized in our last post), the application was approved in 1991 and Rogaine® became available to women on a prescription basis.
The product was a huge success, reaching sales of $100 million per year by 1995.1 On February 9, 1996, just two days before Pharmacia & Upjohn's patent on minoxidil expired, the FDA approved a supplement to NDA 19-501 allowing over-the-counter distribution of 2% minoxidil for men (in a blue package) and women (pink package).
FDA Approval of “Extra-Strength” Minoxidil (5%) for Men
Since earlier studies had shown a dose-dependent increase in the effectiveness of minoxidil for hair regeneration in men,2 it was only a matter of time before studies began to test whether doses higher than 2% minoxidil could be more effective in regrowing hair.
The results of a 48-week, double-blind, placebo-controlled, randomized, multicenter trial in 393 balding men showed that “5% topical minoxidil was clearly superior to 2% topical minoxidil,” producing an earlier response to treatment and resulting in 45% more hair regrowth without evidence of systemic effects from the increased concentration.2 In light of the clear benefits of 5% minoxidil, NDA 20-834 for “Rogaine® Extra Strength For Men (5% Topical Minoxidil Solution),” was approved by the FDA on November 14, 1997.
While the benefits for men were clear, a subsequent trial comparing 5% minoxidil to 2% minoxidil or placebo in female patients did not support its use by women.3 Although the 5% minoxidil solution proved superior to placebo (and resulted in favorable impressions from patients), it did not provide a statistically significant benefit over 2% minoxidil for any of the objective measures of hair regrowth.
Avacor Products’ ANDA for Minoxidil
When Pharmacia & Upjohn’s patents covering topical minoxidil for hair regrowth expired, other companies received FDA approval through the Abbreviated New Drug Application (ANDA) process to manufacture and sell minoxidil for hair regrowth. Avacor Products LLC currently holds such approval in the form of ANDA #075619 and provides topical minoxidil solutions (Avacor Physicians Formulation®) for both men and women.
Make sure to tune in next week when we wrap up the story with the final episode of the Avacor Hair Regrowth Blog’s “Minoxidil Mini-Series.” Our goal with this blog is to provide you with the information you need so that you can make an informed decision about your approach to hair regrowth; part of this process is making sure you have a clear understanding of what you can and cannot expect from using minoxidil.
In the last installment we will give a summary of the benefits that minoxidil can provide, but also explain the limitations and potential side effects you might experience. In the end we hope that having all this information in one place will make it easier for you to navigate the world of hair regrowth treatments and find the right solution for you.
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1. Gellene, Denise. “TV Ads for Rogaine to Sprout.” Los Angeles Times. April 19, 1996. (Accessed July 22, 2011)
http://articles.latimes.com/1996-04-19/business/fi-60266_1_rogaine-sales
2. Shupack JL, Kassimir JJ, Thirumoorthy T, Reed ML, Jondreau L. Dose-response study of topical minoxidil in male pattern alopecia. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):673-6. Link to PubMed
3. Olsen EA, Dunlap FE, Funicella T, Koperski JA, Swinehart JM, Tschen EH, Trancik RJ. A randomized clinical trial of 5% topical minoxidil versus 2% topical minoxidil and placebo in the treatment of androgenetic alopecia in men. J Am Acad Dermatol. 2002 Sep;47(3):377-85. Link to PubMed
4. Lucky AW, Piacquadio DJ, Ditre CM, Dunlap F, Kantor I, Pandya AG, Savin RC, Tharp MD. A randomized, placebo-controlled trial of 5% and 2% topical minoxidil solutions in the treatment of female pattern hair loss. J Am Acad Dermatol. 2004 Apr;50(4):541-53. Link to PubMed
Minoxidil Mini-Series: Introduction
Of all the products sold to combat hair loss and regrow hair, only two have ever been approved by the U.S. Food and Drug Administration (FDA) for regrowing hair: minoxidil and finasteride.
Minoxidil is available for both men and women as a topical treatment, while finasteride (Propecia®) comes in pill form and is not currently indicated for use by women. Minoxidil was first approved by the FDA for hair regrowth in 1988 and continues to be one of the most effective known treatments for androgenetic alopecia (AGA) to date.
In the next few Avacor® Hair Regrowth Blog posts we will recount the history of minoxidil, from its origins as a prescription blood pressure medication to its current use as an over-the-counter hair growth treatment.
We will highlight some of the clinical trials that have shown minoxidil’s effectiveness in stopping hair loss and regrowing hair (for both men and women), explain some of the benefits and limitations of using minoxidil, and describe some potential side effects you might experience.
Stay tuned to the Avacor Hair Regrowth Blog in the next few days for Part 2 of the “Minoxidil Mini-Series”: From Blood Pressure to Baldness.
FDA: “Label Change – Increased Risk of Prostate Cancer” for the hair loss drug Propecia®
On June 9, 2011, the FDA issued a Drug Safety Communication1 about a class of drugs called 5-alpha reductase inhibitors, which includes the hair loss drug Propecia® (finasteride).
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
[6-9-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). This risk appears to be low, but healthcare professionals should be aware of this safety information, and weigh the known benefits against the potential risks when deciding to start or continue treatment with 5-ARIs in men.
Two large clinical trials, known as PCPT and REDUCE, were conducted to assess the use of 5-ARIs for preventing prostate cancer. The PCPT trial raised concern at the FDA because patients being treated with finasteride had a slightly higher risk of developing high-grade prostate cancer than patients receiving placebo (1.8% versus 1.1%, respectively). It should be noted that although the title of the FDA's Safety Alert2 reads "Increased Risk of Prostate Cancer," the data on increased risk appear to relate only to the incidence of high-grade prostate cancer (Gleason Score 8-10).
While the “risk appears to be low,” the labels for drugs including Propecia®, Proscar® (finasteride) and Avodart® (dutasteride) are all being modified to warn patients of this potential risk. Propecia® is also associated with sexual side effects3 in some men, including less desire for sex and difficulty in achieving an erection.
The FDA has provided a page of Questions and Answers on the change in label information for 5-ARIs. Below are a few Q/A’s pertaining to the use of Propecia® for male pattern hair loss.
Q6. Does FDA believe the benefits of 5-alpha reductase inhibitors (5-ARIs) still outweigh their risks for the approved indications?
A. Yes. FDA believes that 5-ARIs remain safe and effective for their approved indications. Proscar and Avodart have been effective in controlling symptoms of benign prostatic hyperplasia (BPH), as well as in reducing the risks of acute urinary retention and the need for surgical intervention related to BPH. Healthcare professionals and patients are still encouraged to discuss the risks and benefits of 5-ARIs when deciding the best treatment for their disease.
FDA will continue its risk/benefit assessment of using 5-ARIs for the treatment for male pattern hair loss and will update the public when additional information is available.
Q9. Are there other medications to treat benign prostatic hyperplasia (BPH) or male pattern baldness?
A. Yes. Another class of medications called alpha-blockers is approved to treat the symptoms of BPH. Medications in the alpha-blocker class include tamsulosin (Flomax), doxazosin (Cardura), terazosin (Hytrin), alfuzosin (Uroxatral), and silodosin (Rapaflo). However, 5-ARIs are the only medications that have been shown to reduce the risk of urinary retention or surgery related to an enlarged prostate.
Minoxidil is a topical product that is available over the counter in various formulations to treat male pattern hair loss.
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1. FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer. June 9, 2011.
http://www.fda.gov/Drugs/DrugSafety/ucm258314.htm
2. 5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer. June 9, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm
3. PROPECIA® labeling information, FDA website.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s018lbl.pdf
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