Gildess Recall FAQs
October 11, 2016
Why is Gildess being recalled?
Par Pharmaceuticals has issued a “Retail Level Recall” of their Gildess line of product, due to the drug having a reduction in the level of Ethinyl Estradiol, one of the two hormones in the birth control pill.
The affected products are as follows:
- Gildess 1.5/30, NDC 0603-7606-48, 3x21 tablets
- Gildess 1.5/30, NDC 0603-7606-15, 6x21 tablets
- Gildess 1/20, NDC 0603-7607-48, 3x21 tablets
- Gildess 1/20, NDC 0603-7607-15, 6x21 tablets
- Gildess Fe 1/20, NDC 0603-7609-17, 6x28 tablets
- Gildess Fe 1.5/30, NDC 0603-7608-17, 6x28 tablets
- Gildess 24 Fe, NDC 0603-7610-49, 3x28 tablets
- Gildess 24 Fe, NDC 0603-7610-17, 6x28 tablets
What is a Retail Level Recall?
A Retail Level Recall is a recall where pharmacies and distributors will quarantine their existing impacted supply on hand and return the medication to the manufacturer. This recall has not been extended to the Patient level, where we would be required by law to contact you. The NYU Student Health Center has decided to extend the recall to the Patient Level.
If you have any impacted medications that were filled by a pharmacy outside of the NYU Student Health Center Pharmacy, please contact them to see what their policies are in regards to exchanging your medication.
What does this mean for me?
The NYU Student Health Center is requesting that students who have any of the impacted medication, regardless if you have started a new pack or not, return to the pharmacy for an exchange.
Will I become pregnant?
All oral contraceptives (OCPs) can be up to 99.7% effective, meaning that there is an inherent risk of pregnancy with any OCPs. The recall notice did not specify a specific percentage of reduction of Ethinyl Estradiol, but with reduction of an active ingredient in an OCP, the effectiveness would be expected to decrease. It is instructive to note that some pill formulations have even lower levels of Ethinyl Estradiol than the impacted medications in this recall and yet still provide pregnancy prevention.
What should I do about changing the pill pack?
THe NYU Student Health Center pharmacy will provide you with an accepted alternative. If you are currently taking Gildess, we will recommend that when you start your OCP replacement pack that you use additional contraception (condoms, abstinence) for 1 week. If you are concerned about being pregnant, please contact Women’s Health to schedule an appointment to be tested. Their number is 212-443-1166.
Will there be side effects when I change manufacturers?
While the new manufacturer’s pills will have a different name and will look different, they will have the same amount of active medication as you were originally prescribed. You should not experience any side effects, but if you do, please contact either the pharmacy or Women’s Health.
September 09, 2016
The NYU Student Health Center continues to follow the development of the spread of the Zika virus. The Centers for Disease Control and Prevention (CDC) has issued a health alert and a level 2 travel advisory encouraging travelers to take enhanced precautions when traveling to affected areas.
Zika virus during pregnancy is a cause of a serious birth defect called microcephaly, which affects the developing brain. In light of this, CDC recommends special precautions for the following groups:
- Pregnant women are advised to postpone travel to affected areas
- Women trying to get pregnant or considering pregnancy in the near future are encouraged to speak to their healthcare provider about any travel plans to affected areas
- Pregnant women who have traveled to an area with ongoing Zika virus transmission should see their healthcare provider to be tested for Zika virus
- Men who have traveled to affected areas should use condoms when having sex with women who are pregnant or may become pregnant
- Women who have Zika virus disease should wait at least 8 weeks after symptom onset to attempt conception
- Men who have Zika virus disease should wait at least 6 months after symptom onset to attempt conception
- Women and Men with possible exposure* to Zika virus but without clinical illness consistent with Zika virus disease should wait at least 8 weeks after exposure to attempt conception
*Possible exposure is defined at travel to or residence in an area of active Zika virus transmission, or sex (vaginal intercourse, anal intercourse, or fellatio) without a condom with a man who has traveled to or resided in an area of active transmission.
Zika virus is almost always spread by mosquito bites. The species of mosquitoes that carry the virus are not typically present in the New York area but are common in tropical and sub-tropical regions.
The virus also can be spread from a man to his sex partners. Transmission of Zika virus from infected women to their sex partners has not been reported. Sexual transmission of many infections is reduced by consistent and correct use of latex condoms. Condoms are available for students free of charge in the Student Health Center as well as in certain areas of Kimmel and the residence halls. For non-students, the New York City Department of Health and Mental Hygiene (DOHMH) distributes condoms free of charge throughout New York City at numerous locations or by calling 311.
Most people who contract the virus are asymptomatic or have mild symptoms which may include rash, fever, conjunctivitis and joint pain. Currently, there is no vaccine against the Zika virus. Treatment is aimed at relieving symptoms.
Anyone traveling to Zika affected areas is advised to follow strict mosquito precautions:
- Wear long-sleeved shirts and long pants
- Sleep in screened-in or air-conditioned rooms
- Sleep under a mosquito bed net
- Use Environmental Protection Agency (EPA)-registered insect repellents
- Treat clothing and gear with permethrin or purchase permethrin-treated items
The Student Health Center will update Zika virus information and links on a regular basis. If you are planning to travel, please check the CDC’s map of affected areas. If you have questions, please call your healthcare provider. NYU students can call the Student Health Center at 212-443-1000.
Mental health in the wake of recent terrorist attacks and threats
June 14, 2016
In light of recent attack in Orlando, Florida, the NYU Student Health Center would like you to take a quick inventory of your mental health. Please read this reminder from Counseling and Wellness Services.