“As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy,” according to a Pfizer statement on the FDA’s website. Pfizer is recalling about a million packets of birth control pills in the United States because [...]
Continue reading...13. January 2012
FDA notified healthcare professionals that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin). Due to the serious nature of PML, a new Boxed Warning highlighting this risk has been added to the drug label. [...]
Continue reading...22. December 2011
U.S. Food and Drug Administration has completed a safety review of Multaq (generic name dronedarone). According to this review, in patients with permanent atrial fibrillation (AF), Multaq increased the risk of serious cardiovascular events, including death. The data was obtained from ATHENA and PALLAS clinical trials. New information and recommendations are being provided by FDA for [...]
Continue reading...14. December 2011
Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants can increase Risk of Persistent Pulmonary Hypertension of the Newborn when used During Pregnancy. SSRI Drugs in dangor: Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone) AUDIENCE: Psychiatry, OB/GYN, Family Practice ISSUE: FDA notified healthcare professionals and [...]
Continue reading...12. December 2011
Over the past few years, FDA has received many reports from numerous surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP (Pelvic Organ Prolapse) and SUI (Stress Urinary Incontinence). These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement. The most frequent complications included erosion through vaginal [...]
Continue reading...26. October 2011
Actos (pioglitazone) is a Type 2 diabetes drug which has been linked to bladder cancer and other injuries. Oral diabetes medication Actos (pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos is used to control type-2 diabetes in patients whose condition is not adequately controlled by [...]
Continue reading...11. August 2011
Pregnant women who take selective serotonin reuptake inhibitors (SSRIs) may be putting their babies at risk for heart defects. SSRIs, which are normally used to treat obsessive-compulsive disorders, anxiety disorders, and depression, have also been linked to heart defects in infants. The risk appears greatest when pregnant women take the drugs in the later part [...]
Continue reading...9. August 2011
Selective serotonin reuptake inhibitors (also known as SSRIs) have been linked to various birth defects in infants whose mothers took the drugs while pregnant. SSRIs are often prescribed to treat patients with various conditions related to anxiety, depression, and obsessive-compulsive disorder. While SSRIs cause a number of side effects in people who take them, mothers [...]
Continue reading...3. August 2011
A drug used to treat yeast infections may be linked to certain birth defects in infants whose mothers took the drug during their pregnancies. Taking frequent, high does of the drug Diflucan (generic name fluconazole) while pregnant has been shown to increase health risks in newborn babies. The risk appears especially great when mothers take [...]
Continue reading...27. July 2011
Birth defects are caused by a number of different factors, some more controllable than others. While some birth defects are hereditary, others are caused by environmental factors. Missing chromosomes and other genes that don’t work properly can lead to malformations in a newborn baby’s body that cannot be prevented by an unborn baby’s environment. However, [...]
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1. February 2012
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