Arizona Medical Malpractice Lawyer Blog

The FDA has determined that Sprycel (dasatinib) (used to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia [ALL]) may lead to an increased risk of dangerously high blood pressure in the arteries of the lungs (pulmonary arterial hypertension). Shortness of breath, fatigue, and swelling of the body (such as the ankles and legs) are some of the symptoms associated with PAH.
For further information on Sprycel, go to: Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

The FDA is continuing to review the increased risk of blood clots supposedly caused by oral contraceptives containing Drospirenone. Data suggest that Drospirenone increases the risk of developing a serious clot (e.g., venous thromboembolism) by as much as 1.5 fold. FDA Drug Safety Communication: Safety Review of possible increased risk of blood clots with birth control pills containing drospirenone

The FDA has issued a mandate to update the risk section of the drug label for Saphris after learning that 52 patients suffered allergic reactions ranging from rashes to anaphylactic shock.

http://www.medpagetoday.com/ProductAlert/Prescriptions/28323?utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news

According to the FDA recent data suggest that oral bisphosphonate drugs increase the risk of cancer of the esophagus. The FDA has not taken a firm position on this, but is simply notifying the public of the potential risk.
For further details, go to: Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer

According to the FDA, Diflucan (used to treat fungal infections; commonly used for yeast infections) when taken long-term and in high doses may increase the risk of birth defects when taken during pregnancy.

FDA Drug Safety Communication:Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants

The FDA recently warned about the increased radiation exposure associated with CardioGen-82. Now they are telling radiologist to stop using it.

FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients

Although small, the risk of cardiovascular complications increases for those taking Chantix. This comes after the FDA recently told the manufacture of Chantix to include the warning that Chantix increases the risk of second myocardial infarction (heart attack). Stop-Smoking Drug Linked to Heart Risks

Including valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics

To report complications resulting from Valproate:

• Complete and submit the report Online: MedWatch Online Voluntary Reporting Form (3500)
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

After two European counties banned Actos, the FDA now warns that Actos increases the risk of bladder cancer in patients who have been taking the drug for more than one year.

FDA Warns of Bladder Cancer Risk With Actos

According to the FDA, Proscar and Avodart, used to treat benign prostatic hypertrophy (enlarged prostate gland), increases the risk of high-grade prostate cancer. Although the risk is considered low, the labeling is being updated to reflect these new findings

FDA Warns of High-Grade Prostate Ca Risk with BPH Drugs

According to the FDA the cholesterol-lowering medication simvastatin 80 mg increases the risk of muscle damage (myopathy). Lower doses, however, are not associate with an increased risk of myopathy.
For additional information, go to: Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

According to the FDA, there are fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and aspirated by the infant/neonate resulting in serous respiratory complications.
For additional information, go to: Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

The FDA has issued a warning that SimplyThick increases risk of necrotizing enterocolitis (NEC), a serious bowel complication that can lead to death of intestinal tissue.

For additional information, go to: SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition

According to the FDA, Plavix (clopidogrel) is less effective for patients who are unable to metabolize the drug. As such, these patients remain at risk of developing blood clots, myocardial infarcts (heart attacks), strokes and other cardiovascular complications.

FDA Announces New Boxed Warning on Plavix
Alerts patients, health care professionals to potential for reduced effectiveness

A new blood test that can quickly determine if a patient has methicillin resistant or susceptible Staphylococcus aureus (MRSA/MSSA) bacteria has received approval from the FDA. http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/26353