Pharmabiz
 

FOGSI clears controversial Depo-Provera for general use

Our Bureau, MumbaiFriday, March 19, 2004, 08:00 Hrs  [IST]

Depo-Provera, the progestin-only contraceptive injectable, which was facing opposition from a group of NGOs, has been cleared by the Federation of Obstetrics and Gynaecologists Society of India (FOGSI). The NGOs had objected to its use on account of its route of administration and supposed side effects. The matter, which was pending with the office of FOGSI for quite some time, has been declared safe for general use, given the minimal side effects it produces, which are similar to the ones shown by other contraceptives in its class. Commenting on the move, Dr Usha Saraiya, obstetrician gynaecologist and past president of FOGSI said that the contraceptive, which ran into trouble soon after its launch, had been formally cleared by the Drugs Controller General of India and also the state FDA for use among women. But then it was not well received by some NGOs' who objected to the mechanism of use (injectable) and also the associated side-effects that arose from the drug. "For more than four years, the matter was subdued with FOGSI as there was nothing objectionable that was found with the molecule regarding its use and side-effects. It ran into trouble for the route through which it had to be administered, which questioned the ethics of its use among several women's groups, being a first-of-its-kind drug in its class. But since then, several other contraceptive injectables are available today, which seems to have resolved the matter among the females users", noted Dr Saraiya. Depo-Provera (DMPA) is the world's most popular and thoroughly researched contraceptive injectable. Approved by the U.S. FDA, this method is safe and effective and is used and trusted by millions of women all over the world. Depo-Provera is highly effective birth spacing method injected every three months. Its water-based composition makes it easy to tolerate and minimizes side effects. Depo-Provera contains a single synthetic progestin similar to the natural progesterone produced in women's body. It is 99.6 per cent effective in preventing pregnancy and is completely reversible. Most women can become pregnant within a year (10 months average) of their last injection. But like any other contraceptive, Depo-Provera does have some side effects. Most women have some changes in their menstrual periods while using Depo-Provera, including irregular and unpredictable bleeding or spotting, an increase or decrease in menstrual bleeding, or no bleeding at all. After 1 year of use, about 2 of 3 women have no bleeding at all. The absence of periods is not harmful, and periods usually return to normal after Depo-Provera is stopped. Other possible side effects include weight gain, headaches, nervousness, abdominal discomfort, dizziness and weakness or fatigue.

 
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