Drug Safety Information

Side Effects: Full Disclosure and Notice

Drugs and medications may have potential side effects. This section provides the user with notice about the known side effects of the medications used in the compounding formulas offered by Lock Lab (“Lock Lab” or “Locklab”). This is not a complete list and there may be additional side effects in the literature that may not be covered in this section.

BY USING LOCKLAB, USERS AGREE THAT IN NO EVENT SHALL LOCK LAB, LLC, ITS OFFICERS, DIRECTORS, EMPLOYEES, HEALTH COUNSELORS, INDEPENDENT CONTRACTORS OR STAFF PHYSICIANS OR AGENTS, BE LIABLE TO YOU FOR ANY DIRECT (INCLUDING DEATH), PSYCHOLOGICAL, EMOTIONAL, INDIRECT, INCIDENTAL, FINANCIAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES WHATSOEVER RESULTING FROM (1) THE PURCHASE AND USE OF PRODUCTS SOLD ON OUR WEBSITE, (2) ANY SIDE EFFECTS THAT THESE MEDICATIONS MAY HAVE EITHER ALONE BY THEMSELVES OR COMPOUNDED TOGETHER IN A FORMULA. IF YOU ARE WORRIED ABOUT THE SIDE EFFECTS OF THESE MEDICATIONS, PLEASE DO NOT USE LOCKLAB. BY AGREEING TO PURCHASE AND USE LOCKLAB, YOU HAVE UNDERSTOOD AND AGREED TO THE SIDE EFFECTS STATED BELOW AND UNDERSTAND THAT ANY OF THESE SIDE EFFECTS MAY OCCUR, AND BE EITHER TEMPORARY OR PERMANENT. YOU ALSO AGREE THAT THERE MAY BE SIDE EFFECTS NOT LISTED AND THIS IS NOT A COMPLETE LIST OF SIDE EFFECTS.

We do not take any responsibility for the safety or efficacy of any of the products sold through this website, nor for any possible side effects that may result due to the use of these products. By viewing this Drug Safety & Information page, you confirm that you have provided accurate medical history and correctly informed your prescribing physician of all ongoing medical conditions, risk factors, medications, and/or allergies and that you have been examined by a physician to confirm your health status prior your telemedicine visit. It is highly encouraged for consumers to ask their personal physicians about the safety and efficacy of such products before use. None of the products sold on this website are intended to treat, prevent, cure, relieve, resolve, or stop any type of medical condition. Compound prescription products have not been tested or approved by the FDA for their intended use. The information provided by our healthcare counselors does not replace talking with your primary care physician regarding your medical conditions and your treatment with oral compounded formulations containing Finasteride, Minoxidil, and Biotin. Please read all this information before you start taking any of our prescribed formulations and please reread this every time you get a new refill, as the information may change and there may be updated, new information provided.

Finasteride Side Effects: Full Disclosure and Notice to Users

Locklab contains Finasteride (oral form). Read this section before you start taking Locklab and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. Finasteride has been FDA approved for use in men for androgenetic alopecia in the oral form, all other formulations are off-label. For full transparency, side effects of Finasteride include but not limited to hypersensitivity reaction (allergic reaction), angioedema, prostate cancer (high-grade), breast cancer, male infertility, impotence, loss in sexual ability, sexual desire, sexual drive, or performance, decrease libido, hypotension, abnormal ejaculation, any form of sexual dysfunction described or not described here, impotence, loss of interest in sex, or trouble having an orgasm, erectile dysfunction, decrease volume of ejaculate, tenderness in genital organs, testicular pain or numbness, infertility, poor seminal quality, poor sperm mobility, penile curviture changes, gynecomastia (enlarge breast tissue), breast tenderness, swelling tingling burning or pain in your face, throat hands or feet, swelling or tenderness in your breasts, lump under the arms or in the breast area, hair loss (temporary or permanent), change in shape of penis, dizziness, weakness, feeling like you might pass out, headache, confusion, brain fog, fogginess of the head, short-term and long-term memory loss, terrible fatigue, trouble concentrating, increasingly moody, depression, mood swings, mood changes, runny nose, sleepiness or unusual drowsiness, slurred speech, sneezing, stuffy nose, abdominal/stomach pain, back pain, decreased amount of semen, diarrhea, hives or welts, itchy skin, rapid weight gain, redness of the skin, skin rash, death, swelling of the lips and face, tingling of the hands or feet, unusual weight gain or loss, breast cancer in males and females, any other cancer in males and females, depression, lower testosterone, complete loss of testosterone, shrinkage of sexual organs, change in sexual orientation and any side effect contributed to what is now called post-finasteride syndrome and listed on the website: www.pfsfoundation.org/about-pfs-post-finasteride-syndrome/. All sexual side effects may be long-term (permanent).

Patients must not share the medication with any female. Finasteride is not FDA approved for use in women, but may be used off-label to treat hair loss in women over 50 in some circumstances. Finasteride is a Category X (teratogenic) medication due to its potential to cause birth defects in male fetuses. Pregnant women and children should not use or come into direct skin contact with Finasteride. The effectiveness of Finasteride for hair loss in women as well as the potential risks/side effects are not well understood because large scale clinical trials have not been done in this population. When used off-label to treat hair loss in women, small studies have indicated that women experience similar side effects to men taking Finasteride (as listed above). Women may additionally experience dry skin, acne, headaches, irregular menses, increased body hair, headache, dizziness, fatigue, weight gain, elevated liver enzyme, edema. There have been reports of breast cancer in men who have taken oral Finasteride and it is unknown how this risk may translate to women.

The above is not a complete list of all side effects or studies conducted. User agrees and understands that there may also be other side effects that may occur that have not been reported, discovered or listed in the literature yet and may have been reported but not listed here. This list is intended to give full transparency about the possibility of most or all of the side effects of Finasteride, some of which may be long term and permanent. User understands and agrees that they have been fully informed about the above side effects. Our goal is to empower our patients to make educated decisions about their treatment choices. We are incorporating the following drug PDR in this section as a reference: https://www.pdr.net/drug-summary/Propecia-finasteride-378.609. Also, on 6/9/2011, FDA released a drug safety communication detailing the long-term side effects of Finasteride and it is referenced here at the following link: https://www.pdr.net/fda-drug-safety-communication/propecia?druglabelid=378&id=8965. In patients taking Finasteride, there is an increased risk of the more advanced stage of (high grade) prostate cancer or serious prostate cancer. In rare cases, male breast cancer has also been reported.

Finasteride & PSA (Prostate Specific Antigen): PSA test is a screening blood test performed by your physician to check for prostate cancer. Finasteride has been shown to reduce the PSA level, sometimes as much as 50%. The significance of this is as follows. Reduction in PSA can mask underlying prostate cancer. When you have a PSA test done, it is imperative that you tell your physician that you are taking Finasteride in order to better assess the real PSA value of your blood test. Any changes from your baseline PSA can indicate a possible prostate cancer, even if your levels are within normal limits. You should always tell your physician if you are or are not taking Finasteride, as this will impact the actual interpretation of your PSA level.

The American Academy of Family Physicians and the Canadian Task Force on Preventive Health Care recommend against PSA-based screening for prostate cancer. The American College of Physicians recommends that clinicians discuss the benefits and harms of screening with men aged 50 to 69 years and only recommends screening for men who prioritize screening and have a life expectancy of more than 10 to 15 years. The American Urological Association recommends that men aged 55 to 69 years with a life expectancy of more than 10 to 15 years be informed of the benefits and harms of screening and engage in shared decision making with their clinicians, taking into account each man’s values and preferences. It notes that to reduce the harms of screening, the screening interval should be 2 or more years. The American Urological Association also notes that decisions about screening, including potentially starting screening before age 55 years, should be individual ones for African American men and men with a family history of prostate cancer. The American Cancer Society adopted detailed screening recommendations in 2016 that highlight the importance of shared decision making and the need for informed discussion of the uncertainties, risks, and potential benefits of screening. It recommends conversations about screening beginning at age 50 years and earlier for African American men and men with a father or brother with a history of prostate cancer before age 65 years.

PREGNANCY WARNING: Females who are pregnant or who may become pregnant should not come in contact with Finasteride. Finasteride may harm your unborn baby. If a woman who is pregnant or a child comes in contact with a Finasteride solution or crushed pills, please wash the area right away with soap and water and contact your healthcare provider. If a pregnant woman with a male baby fetus swallows or comes in contact with Finasteride, the male baby may be born with sex organs that are not normal. Finasteride may also affect sperm counts/quality and can be secreted in the sperm in very low amounts, but currently there are no recommendations based on data from clinical trials to suggest that men should avoid taking Finasteride during conception or while a partner is pregnant.

Minoxidil Side Effects: Full Disclosure and Notice to Users

Locklab contains Minoxidil (oral form). By viewing this Drug Safety & Information page, you confirm that you have provided accurate medical history and correctly informed your prescribing physician of any cardiac, vascular, liver or kidney disease and have been examined by a physician to confirm your health prior your telemedicine visit. Systemic Minoxidil is a potent vasodilator with potential to produce hypotension and reflex tachycardia; serious complications may occur. Minoxidil is relatively contraindicated in patients with cardiac disease (including angina, coronary artery disease, recent or acute myocardial infarction), or cerebrovascular disease because a reflex increase in heart rate and decrease in blood pressure can exacerbate these conditions. Side effects may include pericardial effusion, heart failure, cardiac tamponade, pericarditis, Stevens-Johnson syndrome, allergic reaction, swelling of extremities, edema, peripheral edema , sodium retention, hypotension, angina, sinus tachycardia, leukopenia, thrombocytopenia, bullous rash, contact dermatitis, erythema, mastalgia, headache, hypertrichosis, pruritus, xerosis, vomiting, nausea, irritation, flakiness, itch, tingling and burning. This medication may burn the skin, temporarily or permanently and may cause permanent scarring alopecia.

Minoxidil is classified as pregnancy risk category C. Although no adequate human studies have examined the effects of this drug on the fetus, animal reproduction studies have shown adverse effects, including reduced ability to conceive and a reduced survival of offspring. Dysmorphic facial features and hypertrichosis were observed in an infant whose mother took oral Minoxidil during pregnancy. According to the manufacturer, Minoxidil should not be administered to a nursing mother. Children should not take or come in contact with Minoxidil. Minoxidil can be toxic to some animals, so do not let your pets come into contact with it. We are incorporating the following drug PDR in this section by referencing it here: https://www.pdr.net/drug-summary/Minoxidil-minoxidil-774.