FDA, United States Food and Drug Administration, approved Propecia to begin its sale on 22nd December 1997. The manufacturing company, Merck, was given a green signal to market and sell this prescription drug, which was to be made in form of a pill and to be prescribed to people (especially men) suffering from baldness.
The initial approval was based on clinical trials, a study carried over a time of three years on 1,879 men in the age group 18-41. Increase in hair count was noted in the first 12 months and remained so in men who took Propecia for 24 months. When compared with other placebos, Propecia was found to be most effective in preventing hair loss and thinning.
Patients were questioned to evaluate the individual response they showed towards the treatment. When the drug is taken, Propecia prevents conversion of dihydro-testosterone into testosterone. Prescribed for men only, Propecia has been strictly banned for use in women and children because of its side effects. Expecting mothers who are exposed to the drug are at a higher risk of developing abnormalities in the growing fetus.
Clinical studies clearly demonstrated that side effects were uncommon in men taking Propecia. A very less percentage of the subjects experienced lowered sex drive, decrease in the semen production and were unable to achieve erections for some time. Only 2% of men taking Propecia noted such effects, which disappeared once the treatment was stopped.
FDA thus found no objection while approving Propecia, as no long term and disastrous effects very reported.
A detailed study was ordered in June 2011, while men taking Propecia complained about experiencing serious sexual problems. The study and public response aimed at making alterations in the drug label to help people get aware about the risks. Soon a study on Proscar, a generic form of Propecia, showed the development of prostate cancer among males who were being administered the drug.
Also, prior to the above mentioned event, in March 2011, a study was conducted after being warned by FDA. There was a severe outcry as people taking Propecia alleged that the drug was responsible for triggering depression among them.
Following the above mentioned chain of events, a medication guide was introduced that tried to make men aware about all the possible side effects of Propecia. One prominent effect was the decreased level of PSA or prostate specific antigen that is the first symptom of prostate cancer in males. Men taking this drug were thus advised to undertake a regular screening to help their healthcare expert in evaluating the possibility and severity of this dreaded disease.
With time the side effects of Propecia started getting popular among the masses. Lowered libido, less desire to have sex, decrease in the amount of semen, erectile dysfunction cases were getting noted in an increasing count. The circumstances forced FDA to order a label revision and warned manufacturers to issue strict warning about the risks associated with the use of Propecia.
Although the label has been updated people who have suffered or are suffering because of Propecia are yet to be compensated properly. Merck should not mind settlements as the drug has been like a gold mine for them. It is time that companies who make or intend to make drugs must keep in mind to disseminate all information about the product.
