The proposed warnings will also caution that frequent use may lead to side effects NEW DELHI: Morning-after pills containing levonorgestrel may soon carry four prominent boxed warnings. Govt has proposed that the pills should be labelled clearly as meant only for emergency use, not as regular contraception, not as abortion pills and not as protection against HIV or other sexually transmitted infections.The proposed warnings will also caution that frequent use may lead to side effects and advise users seeking regular contraception to visit a health facility or a registered medical practitioner.Dr Megha Tiwari, Consultant, Obstetrics and Gynaecology, Kailash Hospital & Neuro Institute, said emergency contraceptive pills are an important and safe option when used appropriately, but concerns arise when they start being treated as routine contraception. “We do see women taking it repeatedly after unprotected intercourse, sometimes without understanding that it can disturb the menstrual cycle and cause temporary bleeding irregularities, nausea or anxiety around a delayed period,” she said.“The bigger issue is misinformation. Some women believe the pill can terminate an existing pregnancy, while others assume it offers protection against HIV or other sexually transmitted infections, which it does not,” Tiwari said. She added that the proposed warnings were less about creating fear around emergency contraception and more about ensuring women understood its correct role as a backup method after contraceptive failure, rather than a replacement for regular contraception or condoms.
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The Ministry of Health and Family Welfare has proposed the changes through a draft amendment to Drugs Rules, 1945, covering levonorgestrel tablets of 0.75 mg and 1.5 mg. The warnings would have to appear prominently both on the packaging and the package insert.The proposal also seeks to add levonorgestrel tablets 0.75 mg and 1.5 mg as a specific entry under Schedule K of Drugs Rules, along with conditions relating to their exemption from sale-licence requirements.However, the warnings are not yet mandatory. The notification is a draft, with 30 days invited for objections and suggestions.
