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Bayer’s Acne Drug: EMA Reports Benefits Outweigh the Side Effects

Update Date: May 18, 2013 02:13 PM EDT

Even though acne has been stereotyped as a teenager condition, it affects millions of adults every day as well. For some adults, acne can be uncontrollable and untreatable by store products, forcing them to turn to prescription topical treatments and oral antibiotic options. However, even these prescribed medications can be ineffective for some people, leaving them feeling hopeless with no other way of treating their acne. Due to the fact that acne treatments are in high demand, developing new options and determining whether or not they are safe is important. The European Medicines Agency (EMA) reported that Diane 35 (cyproterone acetate/ethinylestradiol), a hormonal acne treatment, and the generic forms of it could be worth the risks for some women.

Diane 35, which is a hormonal acne treatment that works by regulating hormones and blocking ovulation, has been linked to some risks that include thromboembolism, which occurs when a particle blocks the blood vessels. The EMA's Pharmacovigilance Risk Assessment Committee announced that after an extensive review of the drug and its side effects, Diane 35 is recommended for some women because the benefits could outweigh the risks. The committee stated that only women who are of the reproductive age would qualify for this treatment. The patients must also be suffering from moderate-to-severe acne that is linked to androgen-sensitivity and/or hirsutism, and have found no success with other treatments on the market.

To reinforce the fact that there are potential side effects of the drug, the EMA review stressed that since Diane 35 is a hormonal drug treatment, it should not be taken with other hormonal contraceptives, which could elevate estrogen levels and lead to an increased risk of thromboembolism. The review reported that this risk factor is considered to be relatively low. The EMA review also stated that women prescribed Diane 35 should essentially get a short educational session about the risks in order to encourage women to look out for potential health complications and seek help after.

The review will now be looked over by the Co-ordination Group for Mutual Recognition and Decentralized Procedures-Human (CMDh).

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