Category Archives: OBGYN

Magnesium Sulfate Recommendation Drug Safety Communication

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Magnesium Sulfate: Drug Safety Communication – Recommendation Against Prolonged Use in Pre-term Labor AUDIENCE: OB/GYN, Nursing, Risk Manager ISSUE: FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in … Continue reading

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Posted in FDA 2013, FDA Safety Communication, FDA Warning, Nursing, OBGYN, Risk Manager | Tagged , , , , , , , , , , , | Comments Off on Magnesium Sulfate Recommendation Drug Safety Communication

Natus Medical Incorporated Olympic Cool Cap System Class I Recall

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Natus Medical Incorporated, Olympic Cool-Cap System: Class I Recall – Control Screen Freezes During Treatment AUDIENCE: Risk Manager, OB/GYN, Pediatrics ISSUE: FDA notified healthcare professionals of a Class I Recall of the Olympic Cool-Cap System, because the device’s Control Module … Continue reading

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Posted in FDA 2012, FDA Recall, OBGYN, Pediatrics, Risk Manager | Tagged , , , , , , , , , | Comments Off on Natus Medical Incorporated Olympic Cool Cap System Class I Recall

Generic Ultrasound Transmission Gel Safety Communication

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Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication – Risk of Bacterial Contamination AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, … Continue reading

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Posted in FDA 2012, FDA Warning, Infectious Disease, OBGYN, Radiology, Risk Manager | Tagged , , , , , , , , | Comments Off on Generic Ultrasound Transmission Gel Safety Communication

Birth Control Pills Health Risks

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Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots   AUDIENCE: OBGYN, Family Practice, Patient ISSUE: FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots … Continue reading

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Posted in Family Practice, FDA 2012, FDA Label Change, OBGYN, Patients | Tagged , , , , , , , , , | Comments Off on Birth Control Pills Health Risks

Norgestimate and Ethinyl Estradiol Tablets Recall

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Norgestimate and Ethinyl Estradiol Tablets: Recall – Packaging Error, Potential for Incorrect Dosing Regimen AUDIENCE: OB/GYN, Pharmacy, Patient ISSUE: Glenmark Generics Inc. issued a nationwide, consumer-level recall of seven (7) lots of Norgestimate and Ethinyl Estradiol Tablets USP (0.18 mg/0.035 … Continue reading

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Pfizer Birth Control Pills Lo Ovral 28 Recall

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Pfizer Birth Control Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall – Possibility of Inexact Tablet Counts or Out of Sequence Tablets AUDIENCE: OB/GYN, Healthcare Professionals, Consumers ISSUE: Pfizer Inc. notified healthcare professionals and consumers that it recalled 14 lots of Lo/Ovral-28 (norgestrel and … Continue reading

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Posted in Consumer Products, FDA 2012, FDA Recall, Healthcare Professionals, OBGYN | Tagged , , , , , , , , , , , | Comments Off on Pfizer Birth Control Pills Lo Ovral 28 Recall

Vagifresh Ball Vagifresh Gel Female One Recall

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Vagifresh Ball, Vagifresh Gel, Female One: Recall – Undeclared Drug Ingredient, Bacterial Contamination AUDIENCE: Consumer, OB/GYN ISSUE: USA Far Ocean Group Inc. notified the public of a recall of Vagifresh Ball and Vagifresh Gel, sold as cosmetics. Vagifresh Gel was found … Continue reading

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Posted in Consumer Products, FDA 2012, FDA Recall, FDA Warning, OBGYN | Tagged , , , , , , , , , , , , , , | Comments Off on Vagifresh Ball Vagifresh Gel Female One Recall

Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication

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Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication – Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn   Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, … Continue reading

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Posted in Family Practice, FDA 2011, FDA Notice, OBGYN, Psychiatry | Tagged , , , , , , , , , , , , , , , , , , , , , | Comments Off on Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants Drug Safety Communication

Qualitest Pharmaceuticals Oral Contraceptives Recall

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Qualitest Pharmaceuticals Oral Contraceptives: Recall – Packaging Error includes Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20,  Orsythia, Previfem, Tri-Previfem   AUDIENCE: Consumer, Pharmacy, OB/GYN ISSUE: Qualitest Pharmaceuticals issued a nationwide, retail-level recall of multiple lots of … Continue reading

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Posted in Consumer Products, FDA 2011, FDA Recall, OBGYN, Pharmacy | Tagged , , , , , , , , , , , | Comments Off on Qualitest Pharmaceuticals Oral Contraceptives Recall

Diflucan (fluconazole) Birth Defects

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Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects  AUDIENCE: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the … Continue reading

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Posted in FDA 2011, FDA Notice, FDA Warning, OBGYN, Pharmacy | Tagged , , , , , , , | Comments Off on Diflucan (fluconazole) Birth Defects