Morning-after pills may get 4 boxed warnings

The government of India has proposed adding four prominent boxed warnings to morning-after pills containing levonorgestrel. These warnings aim to clarify the pills' purpose as emergency contraception only, not as regular contraception, abortion pills or protection against sexually transmitted infections. The proposed warnings also caution about potential side effects from frequent use and advise users seeking regular contraception to consult healthcare professionals.

Dr. Megha Tiwari, an obstetrician, explained that while emergency contraceptive pills are generally safe when used correctly, concerns arise when women misuse them as their primary form of birth control. Misinformation plays a role, with some believing the pill can end an existing pregnancy or provide HIV protection, which it does not.

The Ministry of Health and Family Welfare has submitted a draft amendment to the Drugs Rules, 1945, which would require these warnings to be prominently displayed on both the packaging and the package insert. The proposal also seeks to include levonorgestrel tablets 0.75 mg and 1.5 mg in Schedule K of the Drugs Rules, exempting them from the usual sale-licence requirements.

However, the warnings are currently only a draft, subject to a 30-day period for public objections and suggestions.