Are Eyelash-Enhancing Medicines Safe to Use?

During the past year, a steady stream of women (and a few men) have visited my office practice asking about the drug Latisse, a product that darkens, lengthens, and thickens eyelashes, and whether it is safe to use. Before I discuss specific information about this medicine, it is important to understand what the term safe to use actually means.

The safety of medications is determined and overseen in the United States by the Food and Drug Administration (FDA). Actually, several other countries throughout the world also rely on the FDA’s stringent standards for drug safety. Before a drug can be approved for public use by the FDA, it must first successfully pass through a sequence of clinical trials to establish its efficacy, effectiveness, and safety. If a drug meets this standard, it either will be approved for general use (over-the-counter) or restricted use (doctor’s prescription required). A drug typically is placed under restricted use if it is potentially dangerous if used incorrectly, if it carries the possibility for misuse, if its side effects can be potentially severe, or if more data needs to be collected about the spectrum and intensity of its side effects.

Latisse falls into the restricted category, meaning that it only can be used under a doctor’s supervision. The FDA has deemed this drug to be safe if used as directed, with the caveat that a person may experience side effects that can be mild to severe. However, this endorsement is based upon a statistical analysis of data gathered from clinical trials and cannot be applied directly to individual cases. Thus, the critical question is if this product is safe for YOU. In truth, medical science cannot give you this guarantee, as each of us has a unique metabolic profile that is based upon genetics, physiology, lifestyle, and life circumstances. For this reason, it is important to monitor how you are reacting to a medicine and report any side effects that you experience to your physician, regardless of how trivial they might seem to you at the time.

Now that we understand how the safety of medicines is determined, let us address the product Latisse specifically.

On December 5, 2008 the pharmaceutical company Allergan, Inc. received approval from the FDA to market Bimatoprost ophthalmic solution under the trade name Latisse. Since its approval, use of Latisse to enhance eyelash prominence has become a highly popular cosmetic trend.

It is interesting to point out that although the Allergan website promotes Latisse as a treatment for eyelash hypotrichosis (inadequate or insufficient quantity of eyelashes), the actual FDA approval only is for cosmetic purposes. Recently, the FDA gave a formal warning to Allergan, indicating that advertising for the product did not adequately disclose its potential side effects. I will clear up any confusion about its side effects here.

Originally sold under the trade name Lumigan by Allergan in North America and Europe, Bimatoprost ophthalmic solution is a prostaglandin analog that received FDA approval for the treatment of glaucoma and ocular hypertension (elevated pressure inside the eye). However, ophthalmologists prescribing this medication noticed that it appeared to be promoting the growth of longer, fuller, and darker eyelashes in their patients. This prompted Allergan to investigate Bimatoprost as a potential cosmetic preparation.

Since its introduction, more than one million prescriptions of Latisse have been filled. Interestingly, other prostaglandin analogs, such as Latanoprost (Xalatan) – manufactured by Pfizer – and Travoprost (Travatan) – manufactured by Alcon – have similar effects. Thus, other prescription lash-enhancing products likely will be emerging on the market soon.

Clinical trials have demonstrated that Latisse is safe when used as directed at the recommended dosage. However, those that are thinking about using this drug should be aware of its potential side effects, so that you can make an informed decision about whether it is right for you.

In addition to noticing the eyelash-lengthening effects of Bimatoprost, ophthalmologists also reported a tendency for the iris (colored part of the eye) to darken. Hazel and blue eyes may take on brown undertones. Brown eyes may become a deeper brown. This color change appears to be permanent, as it does not change when the drug is discontinued. While this is a tolerable side effect for a patient with glaucoma, when weighed against the prospect of becoming blind, changes in iris color might not be acceptable to those using Bimatoprost for cosmetic lash-enhancing purposes.

Latisse is applied to the upper eyelid margins at the base of the eyelashes. Under no circumstances should it be applied to the lower lashes. There are several reasons for this. One of these is that this drug can cause a darkening of the skin on the upper eyelid. While eye makeup effectively can cover and blend alterations in eyelid color, changes in lower eyelid color are not aesthetically desirable. This is because the darkening will occur under the eye, an area that already is prone to darkening for other reasons. Skin darkening on the upper (or lower) eyelid appears to be reversible if the medicine is stopped.

Latisse also has been reported to induce hair growth on the face in areas where a drop of the drug may have inadvertently fell. This is not a problem for the upper eyelid, since gravity tends to pull any excess medication away from the eyelid and into the eye. However, if applied to the lower lid, gravity has a tendency to cause the drug to bleed into the skin under the eye. Thus, hair growth might be induced in this area in addition to the lash line. This definitely would not be aesthetically pleasing.

If properly applied to the upper eyelid, a sufficient amount of the drug will be transferred to the lower lash line and induce some growth there as well. Thus, there is no need to apply Latisse directly to the lower eyelashes and many reasons not to do it.

Other potential side-effects associated with this drug include:

  • blurred vision
  • eyelid redness
  • eye discomfort
  • temporary burning sensation during use
  • infection if the one-time applicators that come with Latisse are reused
  • lashes may grow so long that they become ingrown and scratch the cornea

Latisse only can be used under a doctor’s supervision. It comes with disposable applicators that are designed to be used once and then discarded. The medication is expensive, costing an average of $120 for a one-month prescription. The same drug sold as an ophthalmic solution costs about half as much and some doctors are prescribing this to their patients. However, doing so raises the possibility of side effects, particularly infection, if the patient has to find alternative means to substitute for the disposable applicators that come with Latisse. Other alternatives also are being sold on the Internet. However, these have not passed through clinical trials to demonstrate their effectiveness and safety. Although their lower price may be attractive, I do not recommend using them. A generic form of Bimatoprost is being sold in Europe under the name Careprost. However, there do not appear to be clinical trials data available for this preparation and it has not been approved by the FDA.

I do not recommend using any product in or around your eyes that has not passed through the extensive testing that is required for FDA approval. Medications failing to meet these standards can have questionable purity, sterility, and consistency. They may also contain additives that can cause undesirable side effects. For example, corticosteroid additives potentially can cause cataracts and elevations in intraocular pressure that can lead to glaucoma.

In summary, Latisse is safe and effective if used as directed, but can have undesirable side effects in some people.

How a Veterinary Pharmacy Can Help With Pet Medications

A veterinary pharmacy provides over-the-counter and prescription pharmaceuticals for animal patients from sterile injectables and ophthalmics to nonsterile oral, topical, and transdermal medications. Commercially available pharmaceuticals often fit the needs of veterinary patients, but sometimes issues arise that impede an animal from taking the drug of choice. A veterinary pharmacy might specialize in individualized pharmaceutical therapies to address such dosing problems. Such facilities are called compounding pharmacies and are operated per state and federal regulations by specially trained pharmacists and technicians.

Compounding is the extemporaneous preparation of a customized pharmaceutical by prescription order from a licensed practitioner. Compounders work in a triad relationship between patient, practitioner, and pharmacist to troubleshoot medication problems and provide individualized therapy to promote the desired health care outcome. In the veterinary realm, compounders can tailor-make drugs for many animals, except for food and food-producing animals per state and federal regulations. What kinds of animals might benefit from compounding? Pets, performance animals, work animals, rescued wildlife, exotics, and more.

Several factors, working singularly or in combination, can contribute to patient noncompliance with the preferred pharmaceutical. A medication might have an unpalatable taste, texture, or scent. The route of administration might need tweaking (such as changing from a tablet to an oral liquid) or rerouting altogether (such as switching from a tablet to a transdermal gel). The preferred therapy might be on temporary back-order or manufacturer discontinued, or the commercially available drug might be too strong for smaller patients (available only in an unscored tablet that cannot be split accurately, for example). Last but not least, the commercially available pharmaceutical might contain irritants or allergens that could be eliminated.

Some of the most frequently requested veterinary compounds include transdermal gels and palatable liquid medications containing active ingredients like methimazole and metronidazole, prescribed often for hard-to-dose cats. Pergolide capsules for horses are also in high demand. Potassium bromide capsules and solutions are also frequently requested. Since the economic downturn, specialty pharmacies have been busy compounding pharmaceuticals that are FDA approved but on temporary back-order or manufacturer discontinued.

When choosing a veterinary compounding pharmacy, one should ask several questions. How long has the pharmacy been in business? Does it charge for shipping? Is the facility licensed to dispense in your state? Does the pharmacy offer compound price matching? Does the pharmacy have a sterile clean room for compounding injectables and ophthalmics?

A veterinary compounding pharmacy can be a helpful partner for practitioners and patients in promoting desired health care outcomes through individualized pharmaceutical therapy.

Make Sure Your Diagnostic Ultrasound Is Operated Safely

Diagnostic ultrasound is an imaging modality that is useful in a wide range of clinical applications, particularly prenatal diagnosis. There is, to date, no evidence that diagnostic ultrasound has produced any harm to humans (including the developing fetus).

Diagnostic ultrasound is generally perceived by users and patients as a safe technique with no adverse effects. Since ultrasound is so widely used in pregnancy, it is essential for all practitioners to ensure that its use remains safe. Ultrasound causes thermal and mechanical effects in tissue which are increased, as the output power is increased.

Most other types of examination are of less concern than are obstetric scans. Specific guidance on a range of non-obstetric examinations (including gynecological, neonatal, ophthalmic, general abdominal, cardiac etc.) can be found in many other sources.

In the last decade, there has been a general trend towards increased output, with the introduction of color-flow imaging, more use of pulsed ‘spectral Doppler’ and higher demands on B-mode imaging. In response to these increases, recommendations for the safe use of ultrasound have been issued by several bodies. In addition, recent regulations have changed the emphasis of responsibility so that more of the obligation is now placed on the operator to ensure that diagnostic ultrasound is used safely.

Despite its apparent excellent safety record, ultrasound imaging involves the deposition of energy in the body, and should only be used for medical diagnosis, with the equipment only being used by people who are fully trained in its safe and proper operation. It is the ultrasound scan operator who is responsible for controlling the output of the ultrasound equipment. This requires a good knowledge of scanner settings, and an understanding of their effect on potential thermal and mechanical bio-effects.

A fundamental approach to the safe use of diagnostic ultrasound is to use the lowest output power and the shortest scan time consistent with acquiring the required diagnostic information. This is the ALARA principle (as low as reasonably achievable). It is acknowledged, that in some situations it is reasonable to use higher output or longer examination times than in others: for example, the risks of missing a fetal anomaly must be weighed against the risk of harm from potential bio effects. Consequently, it is essential for operators of ultrasound scanners to be properly trained and fully informed when making decisions of this nature.

Ultrasound is a mechanical energy in which a pressure wave travels through tissue. Reflection and scattering back to the transducer are used to form the image.

The physical effects of ultrasound are generally categorized as:
* Thermal effects-heating of tissue as ultrasound is absorbed by tissue.
* Heat is produced at the transducer surface.
* Cavitation- the formation of gas bubbles at high negative pressure.
* Other mechanical effects- radiation forces leading to streaming in fluids and stress at tissue interfaces.

The implications of these effects have been determined by in vitro, animal and human epidemiological studies and are briefly summarized below.

The thermal index (TI) and mechanical index (MI) is introduced to provide the operator with an indication of the potential for ultrasound induced bio-effects. TI provides an indication of the relative potential for a tissue temperature rise. MI provides an indication of the relative potential for ultrasound to induce an adverse bio effect by a non-thermal mechanism such as cavitation.

Any potential bio-effects are likely to be of greatest significance in the embryo or fetus. Thus when undertaking obstetric scans restriction to scanning times are recommended these have been formulated on the basis of thermal effects arising from the scan and are therefore based on the thermal index (TI). Obtain diagnostically satisfactory images.

Regulations governing the output of diagnostic ultrasound have been largely set by the USA’s Food and Drug Administration (FDA), although the International Electrotechnical Commission (IEC) is currently in the process of setting internationally agreed-upon standards.

According to the current FDA regulations, the maximum levels for spatial peak time averaged intensity is limited to 720 Mw/cm2. The thermal index is the ratio of the required power used to cause a maximum temperature increase of 1C. A thermal index of 1.0 indicates a power causing a temperature increase of 1C. A thermal index of 2.0 would be twice that power but would not necessarily indicate a peak temperature rise of 2C. The temperature rise is dependent on tissue type and is particularly dependent on the presence of bone.

The mechanical index is an estimate of the maximum amplitude of the pressure pulse in tissue. It gives an indication as to the relative risk of mechanical effects (Streaming and cavitation). The FDA regulations allow a mechanical index of up to 1.9 to be used for all applications except ophthalmic (maximum 0.23).

All current regulations place considerably more responsibility on the user to understand the meaning of the output energy and to apply the lowest usable energy.