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Yaz associated with a higher risk for blood clots
FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. BACKGROUND: Drospirenone is a synthetic version of [...]
Continue reading...FDA Issues warning on counterfeit Avastin
15. February 2012
The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients [...]
Continue reading...Pfizer birth control pills may not prevent pregnancy
1. February 2012
“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...Adcetris brain infection death
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...FDA warning on Multaq and Increased Risk of Death
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...SSRI and Potential Risk of Persistent Pulmonary Hypertension
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...Serious Complications Associated with Vaginal Mesh devices
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...Actos Lawsuit
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...Infant heart defect risks increase with SSRIs
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...Birth defects more likely with SSRI use
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 [...]
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- Risperdal (Resperidone)
- FDA issues warning on Advair, Symbicort, Foradil and Serevent
- Benzoyl Peroxide Acne Cream 10% Contained Burkholderia Cepacia Bacteria
- Crestor Linked to Rhabdomyolysis (Fatal Muscle Disease)
- Merck’s Vioxx $4.85 billion payouts to begin in August
- Zoloft lawsuit
- Infants' Mylicon Gas Relief Dye Free Drops Recalled
- Fluoroquinolone Antimicrobial Drugs
- Arthritis Drug Vioxx Recalled
- Tysabri monotherapy and progressive multifocal leukoencephalopathy
- None found
- Yaz associated with a higher risk for blood clots
- FDA Issues warning on counterfeit Avastin
- Pfizer birth control pills may not prevent pregnancy
- Adcetris brain infection death
- FDA warning on Multaq and Increased Risk of Death
- SSRI and Potential Risk of Persistent Pulmonary Hypertension
- Serious Complications Associated with Vaginal Mesh devices
- Actos Lawsuit
- Infant heart defect risks increase with SSRIs
- Birth defects more likely with SSRI use
10. April 2012
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