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Propecia and Prostate Cancer

Propecia, the popular but controversial hair growth medication, contains finasteride – a chemical that has been promoted by doctors and scientists as an effective means to prevent prostate cancer.  However, after preliminary results from the Prostate Cancer Prevention Trial, some researchers concluded that although finasteride did reduce the overall incidence of prostate cancer, it actually increased a patient’s risk of developing the more dangerous, high-grade forms of prostate cancer.  As a result, the FDA has issued a warning regarding all drugs containing finasteride, urging doctors to weigh the benefits of the drugs against their potential risks.

Propecia and prostate cancer

Finasteride is a chemical that inhibits the production of a hormone called DHT.  DHT contributes to male pattern baldness, prostate enlargement, and prostate cancer, and finasteride has been proven effective in treating all three of these conditions.  Finasteride is approved by the FDA for the treatment of prostate enlargement under the name Proscar at a dosage of 5 mg/day.  Propecia contains a low dose (1 mg) of finasteride for use in treating male pattern baldness. Both are manufactured by pharmaceutical giant, Merck.

Studies of the impact of finasteride on prostate cancer rates and severity have involved the 5mg preparation, and Propecia has not been shown to cause prostate cancer.  However, Propecia has been proven to mask some of the symptoms and effects of prostate cancer, like prostate enlargement and elevated levels of a chemical called PSA which is produced by the prostate.  This may interfere with early detection and diagnosis, meaning that for men taking Propecia prostate cancer may develop into a more advanced and aggressive stage before treatment is begun and therefore result in a worse prognosis.  The FDA warns medical professionals to be aware of the symptom-masking effects of Propecia and urges patients to discuss screening options with their doctors when taking Propecia.

Prostate cancer symptoms and diagnosis

Prostate cancer usually develops in older men, and symptoms usually do not appear until the cancer is in its later stages, causing the prostate to swell.  A swollen or enlarged prostate may also be a sign of a benign condition called BPH, or benign prostatic hyperplasia, so patients with symptoms of an enlarged prostate should seek medical attention to determine whether their prostate growth is benign or cancerous.

Symptoms of an enlarged prostate, which might be an indication of cancer, may include:

  • Trouble urinating
  • A frequent need to urinate
  • Weak stream when urinating
  • Blood in urine or semen
  • Leg swelling
  • Pelvic or bone pain

A doctor may check for prostate cancer by administering a physical prostate exam as well as a blood test which checks the levels of a chemical called PSA in the blood stream.  Elevated PSA may be an indication of prostate cancer.  Because Propecia and other similar medications can decrease PSA, they can throw off the results of a PSA test.  A doctor can also use ultrasound imaging or a biopsy to examine the prostate in suspected cancer cases.

Propecia prostate cancer FDA warnings

The FDA has issued several warnings about Propecia and prostate cancer.  Federal regulators have issued similar warnings for Proscar, Avodart, Jalyn, generic formulations of Propecia, and other drugs (called 5-ARIs) that are similar to Propecia.

The following Propecia prostate cancer FDA warnings apply to all drugs in this class:

  • On June 9th, 2011, the FDA issued a Drug Safety Communication warning the public that Propecia may increase the risk of a more serious form of prostate cancer.
  • The FDA prescribing information product label for Propecia was also updated to include the warning about high-grade prostate cancer. The information cautions that Propecia reduces PSA levels and urges doctors to take this into account when testing for prostate cancer.

Propecia litigation

The manufacturers of Propecia – Merck & Co., Inc., and subsidiary Merck, Sharp, & Dohme – are facing hundreds of lawsuits alleging that the drug caused side effects ranging from erectile dysfunction, loss of libido, and other sexual side effects, to depression, memory problems, “brain fog,” and other cognitive impairment.  In many cases, Propecia side effects can be persistent or permanent and do not resolve after discontinuation of the drug.  Propecia plaintiffs seek compensation for damages including medical expenses, pain and suffering, permanent disability, and emotional trauma.

Over 180 Propecia lawsuits have been consolidated for multidistrict litigation in New York, meaning the plaintiffs alleging these side effects will share information and pretrial rulings in order to conserve resources and encourage settlements.