pregnancy

Monitoring Options Expand for Therapeutic Agents and Drugs of Abuse

...s using a technology similar to that found in home pregnancy tests. Through the patented delivery system, urine reacts with the reagents and antigens on the strip to produce a colorimetric reading indicating either positive or negative test results. Craig Medical Distribution, Inc., Vista, Calif., produces th...

Genetic Analysis Systems Enter the Clinical Mainstream

...tion genetics is sometimes critical for predicting pregnancy outcome and future quality of life. Vysis, Inc., Downers Grove, Ill., a division of Abbott Laboratories, has gained FDA approval for its Aneuvysion assay, the only FDA cleared product to test for prenatal aneuploidy. Vysis offers an expansive line of...

New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV

... treated patients. PREZISTA should be used during pregnancy only if the potentialbenefit justifies the potential risk. There are no adequate andwell-controlled studies in pregnant women. The effects of PREZISTAon pregnant women or their unborn babies are not known. In the pooled analysis of POWER 1 and 2 stu...

Aspreva and Roche Announce Preliminary Results for Phase III Study Evaluating CellCept in Lupus Nephritis

...ing potential should have a negative serumor urine pregnancy test with a sensitivity of at least 50 mIU/mLwithi...aneously unless abstinence is thechosen method. If pregnancy occurs during treatment, the physicianand patient should discuss the desirability of continuing thep...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

...es in pregnant women. JANUVIAshould be used during pregnancy only if clearly needed. Cautionshould be exercised... of human response, this drug shouldbe used during pregnancy only if clearly needed. Merck & Co., Inc.maintains a registry to monitor the pregnancy outcomes ...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

...es in pregnant women. JANUVIAshould be used during pregnancy only if clearly needed. Cautionshould be exercised... of human response, this drug shouldbe used during pregnancy only if clearly needed. Merck & Co., Inc.maintains a registry to monitor the pregnancy outcomes ...

Interim Analysis of Crinone Pregnancy Study to Be Published in American Society for Reproductive Medicine Journal

...CBRX) announced today that an interimanalysis of a pregnancy study comparing the efficacy of CRINONE(R)8% (prog...ospective randomized controlled study isevaluating pregnancy rates and successful long-term pregnancies in400 women treated with CRINONE 8% progesterone vaginal ...

New Data Presented on Micardis (Telmisartan) Tablets in Hypertensive Patients With Type 2 Diabetes

...Safety Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters,drugs that ...njury and even death to the developing fetus. When pregnancy isdetected, MICARDIS Tablets should be discontinued as soon aspossible (see WARNINGS, Fetal/Neonatal...

Adding Thalidomide to Standard Therapy Improves Survival in Newly Diagnosed Multiple Myeloma Patients Over Age 75

... (onecapsule) taken by a pregnant woman during her pregnancy can causesevere birth defects. Thalidomide should never be used by women whoare pregnant or could become pregnant. Male and female patientsmust follow the contraception measures in the Pharmion RiskManagement Programme. The common adverse reactions ...

Efficacy and Safety Profile of Basilea's Alitretinoin for Severe Refractory Chronic Hand Eczema Confirmed by Data Shown at European Dermatology Congress

...tory CHE.Alitretinoin is a teratogen and therefore pregnancy preventionmeasures must be in place for all women of child-bearing potentialwho receive alitretinoin. Within days after discontinuation oftherapy, alitretinoin levels return to endogenous levels. Inclinical studies the post-treatment contraceptive pe...

Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

...Safety Information USE IN PREGNANCY When used in pregnancy during the second and third trimesters,drugs that ...njury and even death to the developing fetus. When pregnancy isdetected, BENICAR or BENICAR HCT should be discontinued as soon aspossible. See WARNINGS, Fetal/Ne...

New Study Demonstrates that Lubiprostone May Improve Symptom Relief Rates in Adults with Irritable Bowel Syndrome with Constipation (IBS-C)

...ating AMITIZA treatment. The safety of AMITIZA in pregnancy has not been evaluated inhumans. In guinea pigs, lubiprostone has been shown to have thepotential to cause fetal loss. AMITIZA should be used duringpregnancy only if the benefit justifies the potential risk to thefetus. Women who could become pregnan...

Schering-Plough Announces Hepatitis C Data Presentations at Digestive Disease Week (DDW) 2007 Annual Meeting

...houldnot be initiated until a report of a negative pregnancy test hasbeen obtained immediately prior to initiat...ntieth of therecommended human dose of REBETOL. If pregnancy occurs in a patientor partner of a patient during treatment or during the 6 monthsafter treatment st...

Data Published in The Lancet Show Gardasil was 100 Percent Effective in Preventing High-Grade Vulvar and Vaginal Lesions Caused by HPV Types 16 and 18

...ied. In clinical studies, women underwent urine pregnancy testing priorto administration of each dose of GAR...cine = 1115 vs. placebo =1151) reported at least 1 pregnancy each. Overall, the proportions ofpregnancies with an adverse outcome were comparable in subjects who...

New England Journal of Medicine Publishes New Data on Gardasil, Merck's Cervical Cancer Vaccine

...ied. In clinical studies, women underwent urine pregnancy testing priorto administration of each dose of GAR...cine = 1115 vs. placebo =1151) reported at least 1 pregnancy each. Overall, the proportions ofpregnancies with an adverse outcome were comparable in subjects who...

Early Results of the CellCept Spare the Nephron Study Examine Kidney Function

...ingpotential should have a negative serum or urine pregnancy test witha sensitivity of at least 50 mIU/mL withi...aneously unless abstinence is thechosen method. If pregnancy occurs during treatment, the physicianand patient should discuss the desirability of continuing thep...

Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of Tysabri in Patients with Multiple Sclerosis

...ls and registries, includingSTRATA, TYGRIS and the pregnancy registry. According to dataavailable to the compan...TYSABRI. The combination of TOUCH, TYGRIS and the pregnancy registry willbe the largest long-term follow-up undertaken for an MS therapy,and the companies plan ...

Columbia Laboratories Reports Preliminary Findings from the Ongoing Data Analysis of the Phase III Clinical Study of PROCHIEVE 8% (progesterone gel) to Prevent Preterm Birth

...tens of thousands of women globally to helpsustain pregnancy at the early stages for ten years. The most common side effects of PROCHIEVE 8% include breastenlargement, constipation, somnolence, nausea, headache, andperineal pain. PROCHIEVE 8% is contraindicated in patients withactive thrombophlebitis or throm...

Basilea Reports Positive Re-treatment Results from a Second Phase III Trial of Alitretinoin for Patients with Severe Chronic Hand Eczema

...ffects. Alitretinoin is a teratogen and therefore pregnancy preventionmeasures must be in place for all women of child-bearing potentialwho receive alitretinoin. Within days after discontinuation oftherapy, alitretinoin levels return to endogenous levels. Inclinical studies the post-treatment contraceptive pe...

Ferring Reports on ENDOMETRIN Presentations at Pacific Coast Reproductive Society Annual Meeting

...ualityluteal phase support, measured by continuing pregnancy rates, andit is administered in an easy, patient- ...icacy parameters between treatmentarms. Continuing pregnancy rates were 42.3 percent with ENDOMETRINTID and 38.6 percent with ENDOMETRIN BID. The groups also sho...

Schering-Plough Addresses Major Milestones and Challenges in Treatment of Patients With Chronic Hepatitis C

...houldnot be initiated until a report of a negative pregnancy test hasbeen obtained immediately prior to initiat...ntieth of therecommended human dose of REBETOL. If pregnancy occurs in a patientor partner of a patient during treatment or during the 6 monthsafter treatment st...