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  • 2021-12-07 (xsd:date)
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  • Shelf Life of Mifepristone and Misoprostol – Truth or Fiction? (en)
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  • Shelf Life of Mifepristone and Misoprostol Claim Mifepristone has a shelf life of about 5 years, and misoprostol has a shelf life of about 2 years. Rating Decontextualized Like this fact check? Reporting As discourse about the future legality of abortion continued on December 6 2021, an Imgur user shared a screenshot of two tweets addressing the shelf lives of mifepristone and misoprostol — two drugs known to terminate a pregnancy: In the depicted exchange, advice columnist Dan Savage broadly asked if anyone knew the shelf life of mifepristone and mifeprostol. Public health expert Dr. Dan Grossman responded, indicating that the medications had shelf lives of five and two years, respectively: Hey @fakedansavage , great question! Advance provision of abortion pills before you need them makes a lot of sense. Mifepristone has a shelf life of about 5 years, and misoprostol has a shelf life of about 2 years. https://t.co/VbJ4HzDpRM — Dr. Daniel Grossman (@DrDGrossman) December 6, 2021 Although the tweet above did not receive significant engagement, the Imgur screenshot was viewed more than 100,000 times. A very similar post appeared on Reddit’s r/abortion in May 2019: Florida is where wokes go to die... Please enable JavaScript Florida is where wokes go to die Shelf-Life of Mifepristone & Misoprostol? from abortion What are Mifepristone and Misoprostol? According to a Food and Drug Administration (FDA) fact sheet for Mifeprex (mifepristone): Mifeprex is used, together with another medication called misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000. In 2016, the agency approved a supplemental application for Mifeprex based on data and information submitted by the drug manufacturer. After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling. [...] Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). Of misoprostol (a medication also used to prevent ulcers caused by NSAID pain relievers), WebMD said : This medication [misoprostol] is used to prevent stomach ulcers while you take NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it. This medication is also used in combination with another drug (mifepristone) to end a pregnancy (abortion). An April 2021 paper in the American Academy of Family Physicians’ American Family Physician explained the manner in which the medications were dispensed in concert, and the timeframe during which they could be used to terminate a pregnancy: Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days’ gestation and for medication abortion up to 77 days’ gestation. Gestational age is determined using ultrasonography or menstrual history. Ultrasonography is needed when gestational dating cannot be confirmed using clinical data alone or when there are risk factors for ectopic pregnancy. The most effective regimens for medication management of early pregnancy loss and medication abortion include 200 mg of oral mifepristone (a progesterone receptor antagonist) followed by 800 mcg of misoprostol (a prostaglandin E1 analogue) administered buccally or vaginally. Cramping and bleeding are expected effects of the medications, with bleeding lasting an average of nine to 16 days. The adverse effects of misoprostol (e.g., low-grade fever, gastrointestinal symptoms) can be managed with nonsteroidal anti-inflammatory drugs or antiemetics. Ongoing pregnancy, infection, hemorrhage, undiagnosed ectopic pregnancy, and the need for unplanned uterine aspiration are rare complications. Clinical history, combined with serial quantitative beta human chorionic gonadotropin levels, urine pregnancy testing, or ultrasonography, is used to establish complete passage of the pregnancy tissue. Medication management of early pregnancy loss and medication abortion has become increasingly common since the U.S. Food and Drug Administration (FDA) approval of mifepristone (Mifeprex) in 2000. Medication abortion now accounts for 60% of all abortions completed before 10 weeks’ gestation. In sum, mifepristone and misoprostol are oral medications, one of which is also used to prevent stomach ulcers (misoprostol). Both medications are considered safe and effective for outpatient use in terminating a pregnancy up through 77 days’ gestation. What’s a Shelf Life in Relation to Medication, and How Does it Relate to Mifepristone or Misoprostol? Drugs.com’s entry on expired medications provided context about shelf lives overall: What does an expiration date mean? The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. U.S. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date. However, for most drugs, it’s just an arbitrary date, usually 1 to 5 years out, that the manufacturer selects to test drug stability . Once the container of medication is opened after production, that expiration date is no longer guaranteed. A December 2014 paper in the journal PLOS One , Instability of Misoprostol Tablets Stored Outside the Blister: A Potential Serious Concern for Clinical Outcome in Medical Abortion, addressed inherent risks of deterioration when its manufacturer’s packaging was damaged: In such conditions, at the time of drug intake, a decrease in active misoprostol components associated with an increase in inactive degradation products is expected to occur. Correct dosing is of crucial importance for clinical procedures that rely on misoprostol such as medical termination of pregnancy, medical management of miscarriage, and cervical ripening, because dosage recommendations for misoprostol in these indications are based on the lowest effective dose, with the intention to keep side effects at a minimum. Consequently, treatment guidelines do not contain a ‘safety margin’ to compensate for a reduced content of the active ingredient due to degradation. [...] Exposure of Cytotec tablets to ‘typical’ European levels of air and humidity results in significant time-dependent changes in physical and biological composition that could impact adversely upon clinical efficacy. Health professionals should be made aware of the degradation of misoprostol with inappropriate storage of misoprostol tablets. Shelf Life of Misoprostol Grossman’s response to Savage’s tweet indicated the shelf life of misoprostol was about [two] years. Two years was the precise figure cited in a United States Agency for International Development (USAID) document [ PDF ] pertaining to misoprostol. The Reproductive Health Supplies Coalition [ PDF ] referenced a slightly broader window, from 18 months to 36 months (or three years): Misoprostol is available in tablet form, and marketed products typically have a shelf life of 18 to 36 months when stored below 25°C to 30°C (77°F to 86°F) in a dry area. Misoprostol directives often note that storage conditions and temperature affect the safety and efficacy of stored tablets. Shelf Life of Mifeprestone Grossman added that the shelf life of mifeprestone was about [five] years. A document on reproductiveaccess.org, Mifepristone Ordering Information, [ PDF ] read: Shelf life of mifepristone is 18 months. However, an Indian pharmaceutical resource referenced a five year shelf life, as Dr. Grossman did in the tweet. Medicines.org.uk listed the shelf life of mifeprestone as four years; a separate UK source [ PDF ] indicated a shelf life of three years. A 2016 World Health Organization (WHO) study [ PDF ] from 2016 discussed variables in the shelf life of mifeprestone, reporting: Misoprostol is a viscous oil, extremely susceptible to degradation. This is ameliorated by using a 1% dispersion of misoprostol in hydroxypropyl methyl cellulose (HPMC), which is considerably more stable and allows the manufacture of tablets with a shelf life of several years at room temperature . Nevertheless, exposure to water has been shown to be the principal driver in the degradation of misoprostol in tablets, and can occur during manufacture through the use of inappropriate excipients or inadequately controlled environmental conditions. Tablets can also be exposed to moisture depending on their packaging. Polyvinyl chloride (PVC) or polyvinylidene chloride (PVDC)/aluminium blister packs do not provide adequate protection against penetration by moisture, a double aluminium blister pack is therefore recommended. Estimates for mifeprestone’s shelf life varied quite a bit, with some tablets being rated as safe for five years. Storage conditions for mifeprestone (like misoprostol) were contextually important, with exposure to moisture cited by the WHO as an accelerating factor in reducing efficacy. Summary A Twitter exchange between Savage and Grossman about the shelf life of mifeprestone and misoprostol was shared to Imgur in December 2021, against the backdrop of concerns about reduced access to abortion. Grossman’s response — hampered by Twitter’s character limits — indicated that misoprostol had a shelf life of approximately two years, and mifeprestone could be safely stored for up to five years. As approximations, Grossman’s tweet was accurate, and the information useful for individuals who sought to store the medications in question for potential future use. We rated the claim Decontextualized , not because of any inaccuracy in the tweet, but to highlight controllable variables such as temperature and exposure to moisture that could reduce the efficacy of either medication when used together. Posted in Fact Checks , Viral Content Tagged abortion , dan savage , imgur , mifeprestone , mifepristone shelf life , misoprostol , misoprostol shelf life , ru-486 shelf life , viral tweets (en)
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