July 23, 2019 -- Salisbury, Maryland, Jubilant Cadista Pharmaceuticals Inc. is voluntarily recalling one lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/ 0.02mg, 28x3 Blister Pack/Carton to the consumer level. The FDA Alert(s) below may be specifically about drospirenone/ethinyl estradiol or relate to a group or class of drugs which include drospirenone/ethinyl estradiol. To date, Jubilant Cadista Pharmaceuticals Inc. has not received any reports of adverse events related to this recall. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. This product is used to prevent pregnancy. or have questions regarding this recall please contact your pharmacy. These two new studies reported that there is a greater risk of VTE associated with birth control pills that contain drospirenone. It’s super easy to use. Reviews / Information Included in this NDA Review. This medicine combines two types of female hormones, an estrogen and a progestin. The FDA requires all potential medication risks for DROSPIRENONE AND ETHINYL ESTRADIOL (kit) be disclosed to consumers, no matter how rare. Missing pills can cause spotting or light bleeding. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Third Party materials included herein protected under copyright law. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. To date, no case has been reported for pregnancy and adverse event to Apotex. Here are the warnings and precautions for DROSPIRENONE AND ETHINYL ESTRADIOL. The affected product is manufactured by Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain under contract from Jubilant Cadista Pharmaceuticals Inc., 207 Kiley Drive Salisbury, Maryland 21801. The link is provided below. Risk Statement : As a result of this packaging error, where a patient does not take a tablet due to a missing tablet or that a patient takes a placebo instead of an active tablet, loss of efficacy is possible due to variation in the dosage consumed. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). Patients / users that have the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP which are being … MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. Approval Letter X Other Action Letters Labeling X Summary … Drospirenone 3 mg and ethinyl estradiol 0.02 mg. Ocella. Stop at least 4 weeks before and through 2 weeks after major surgery. Patients / users that have the affected lots of Drospirenone and Ethinyl Estradiol Tablets, USP which are being recalled should consult with their healthcare provider. and Patient Labeling. Wholesalers, distributors, and retailers should immediately examine their inventory for the affected lot. Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, lot 183222 was distributed Nationwide to wholesalers, distributors, and retailers. It works by stopping a woman's egg from fully developing each month. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. ISSUE: FDA is aware of two newly published studies that evaluated the risk of venous thromboembolism (VTE) in women who use birth control pills that contain drospirenone. Drospirenone/ethinyl estradiol Sponsor: Bayer HealthCare Pharmaceuticals Inc. Approval Date: April 10, 2012 Indications: YASMIN is indicated for use by women to prevent pregnancy. WARNING TO WOMEN WHO SMOKE. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. Most birth control pills contain two types of hormones--estrogen and progestin. Our servers have detected that you are accessing this site from a country that is a member of the European Union. Taking drospirenone and ethinyl estradiol can increase your risk of blood clots, stroke, or heart attack. Missing pills can cause spotting or light bleeding. Drospirenone and ethinyl estradiol tablets (inner carton) consists of 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and 7 placebo white color tablets. Ethinyl Estradiol, Drospirenone, and Levomefolate This information from Lexicomp explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider. BACKGROUND: Drospirenone is a type of female sex hormone called a progestin. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk. Women over 35 years old who smoke should not use Drospirenone and Ethinyl Estradiol Tablets, USP 3 mg/0.02 mg ().Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. Patients that have used the affected lot of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg should consult their healthcare provider. All Rights Reserved. Nikki (drospirenone and ethinyl estradiol tablets USP), 3 mg/0.02 mg is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. This risk is reported to be up to 2 to 3 times greater than the risk of VTE associated with using levonorgestrel-containing pills. Nausea, vomiting, headache, abdominal cramps, bloating, breast tenderness, swelling of the ankles /feet (retaining fluid), or weight change may occur. Drospirenone And Ethinyl Estradiol … Always consult a medical provider for diagnosis and treatment. FDA’s review of the results of this study, specifically those results related to drospirenone-containing birth control pills, will be presented and discussed at the joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. The progestin drospirenone may increase potassium. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Apotex Corp. has notified its affected wholesalers and distributors via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. All inventory of the affected lot should be quarantined to prevent further distribution to patients. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from hormonal birth control (such as the pill, patch, ring). See also Precautions section. Before taking this medicine. Drospirenone/Ethinyl Estradiol Warnings Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Jubilant Cadista Pharmaceuticals Inc. is notifying its customers by emailing a recall notification letter and response form and is arranging for return of all recalled product. Including Black Box Warning. Consumers with questions regarding this recall can contact Apotex corp.  by phone-number 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com . Patients may return the affected lot to their place of purchase. Do not smoke or use tobacco. Audience: OBGYN, Family Practice, Patient. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented. The length of time required for using a second method of contraception after drug initiation is slightly different for each manufacturer. [UPDATED 09/26/2011] FDA has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. The risk of these serious problems increases with age and with the number of cigarettes you smoke. Apotex Corp.  has notified its affected wholesalers and distributors via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product. Here are the warnings and precautions for Syeda. The mean exposure to DRSP in women with moderate liver impairment is approximately three times higher than the exposure in women with normal liver function. Select one or more newsletters to continue. The affected Drospirenone and Ethinyl Estradiol Tablets, USP lots include the following and can be identified by NDC numbers stated on the inner and outer cartons: The affected Drospirenone and Ethinyl Estradiol Tablets were distributed Nationwide to wholesalers and distributors. RECOMMENDATION: Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use. Data sources include IBM Watson Micromedex (updated 7 Dec 2020), Cerner Multum™ (updated 4 Dec 2020), ASHP (updated 3 Dec 2020) and others. Drospirenone Ethinyl Estradiol uses a blend of two hormones, estrogen and progestin, to make your body think it’s pregnant so a real pregnancy won’t happen. The two recently published studies looked at whether there is a higher risk of blood clots in women taking birth control pills containing the progestin drospirenone when compared to similar women taking birth control pills containing a different progestin called levonorgestrel. It is used to prevent ovulation and pregnancy. Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Warnings Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. This weight gain is usually the result of water retention and often reverses if/when you discontinue the medication. For the latest FDA MedWatch alerts, go here. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. It contains 2 hormones: drospirenone (a progestin) and ethinyl estradiol (an estrogen). What is DROSPIRENONE/ ETHINYL ESTRADIOL/ LEVOMEFOLATE CALCIUM? Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Ethinyl Estradiol and Drospirenone 5/11. Audience: Consumer, Health Professional, Pharmacy. Birth control pills work by preventing the release of eggs from the ovaries (ovulation) and changing the cervical mucus and the lining of the uterus to prevent pregnancy. Drospirenone and Ethinyl Estradiol Tablets, USP are an estrogen/progestin COC indicated for use by women to prevent pregnancy. This content is not available in your region. The FDA requires all potential medication risks for SYEDA (drospirenone and ethinyl estradiol kit) be disclosed to consumers, no matter how rare. 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