The US Food and Drug Administration (FDA) is warning clinicians not to use Other‐Sonic Generic Ultrasound Transmission Gel because of bacterial contamination.
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The high court must decide whether a ruling on the ACA’s individual mandate must wait until the IRS begins to assess the penalty — or is it a tax? — for noncompliance in 2015.
Medscape Medical News

The CHMP has confirmed a positive benefit-risk balance for strontium ranelate, but recommends new contraindications and revised warnings.
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The CHMP has confirmed a positive benefit-risk balance for strontium ranelate, but recommends new contraindications and revised warnings.
News Alerts

The agency cautions, however, that women receiving any silicone breast implant require lifelong monitoring.
FDA Approvals

A packaging error has led to both active and inactive norgestimate contraceptive tablets being out of sequence.
News Alerts

The FDA is warning that PPIs may be associated with a higher risk for Clostridium difficile-associated diarrhea, a persistent illness that comes with abdominal pain and fever.
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Pfizer has voluntarily recalled 14 lots of Lo/Ovral-28 tablets and 14 lots of the generic version because of the possibility of inexact tablet count or out-of-sequence packaging.
News Alerts

The emergency contraceptive pill stays prescription only for those under 17 years old.
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Further analysis of an FDA-funded study provides more evidence that drospirenone-containing oral contraceptives increase risk for venous thromboembolism, the agency says.
Medscape Medical News

Although several jet-injection devices are approved for delivering vaccines and other medications, no influenza vaccine has been cleared for this method of administration.
Medscape Medical News

The European Medicines Agency is now reviewing all relevant data on cardiovascular and cutaneous safety concerns for Protelos and Osseor.
Medscape Medical News

The US Food and Drug Administration remains concerned about drospirenone-containing oral contraceptives and increased risk for venous thromboembolism.
Medscape Medical News

A packaging error has prompted generic drugmaker Qualitest Pharmaceuticals to recall multiple lots of oral contraceptives.
Medscape Medical News

In light of more fatal cases of acute renal failure, the agency is revising the label of zoledronic acid when used for osteoporosis.
Medscape Medical News

The agency says long-term use of fluconazole (Diflucan) in high doses in the first trimester may be associated with birth defects.
Medscape Medical News

An unapproved morning-after pill called Evital has not been shown to be safe or effective in preventing pregnancy, the FDA warns.
Medscape Medical News

The agency continues to review studies that reach different conclusions on the possible association between esophageal cancer and the widely prescribed drugs for osteoporosis.
Medscape Medical News

American Regent is voluntarily recalling its calcium gluconate injection, USP, 10% 100 mL pharmacy bulk package, lot number 1006, because some vials may contain silicone particles.
Medscape Medical News

The FDA has issued a white paper and a second warning about transvaginal placement of surgical mesh to repair pelvic organ prolapse, saying other options may expose women to less risk.
Medscape Medical News

The FDA is adding cognitive delay to warnings about neural tube defects in children of mothers taking valproate vs other antiepileptic drugs.
Medscape Medical News

The FDA is adding cognitive delay to warnings about neural tube defects in children of mothers taking valproate vs other antiepileptic drugs.
Medscape Medical News

An FDA study of silicone gel-filled breast implants found that the devices are safe and effective, but that women with implants are likely to experience complications.
Medscape Medical News

Concerns over potential cross-contamination of nonpenicillin drug products with penicillin have resulted in a nationwide recall of multiple repackaged products.
Medscape Medical News

The FDA has warned that thermography (the use of infrared cameras to measure heat and blood flow near the body’s surface) is not a substitute for mammography.
Medscape Medical News

The US Food and Drug Administration has announced that they will further review drospirenone-containing oral contraceptives and venous thromboembolism risk.
Medscape Medical News

iCAD Axxent FlexiShield Mini silicone pads with tungsten are subject to a US Food and Drug Administration class I recall.
Medscape Medical News

An FDA review indicates that the risk for liver injury is low, eliminating the need for liver enzyme tests every month. However, women of childbearing age who take the drug still need monthly pregnancy tests.
Medscape Medical News

New human data show that the prevalence of cleft lips and palates in infants born to women taking topiramate was roughly 3 times higher than that for women taking other antiepileptic drugs.
Medscape Medical News

Taking these medications during the third trimester of pregnancy puts neonates at risk for abnormal muscle movements and withdrawal symptoms.
Medscape Medical News