Search Results for: fda

Botox cosmetic alternatives for wrinkles

With the recent announcement by the United States Food and Drug Administration that there is an ongoing safety review of Botox Cosmetic (botulinum toxin type A), customers are looking for alternatives to treat frown lines between the brows. – Facial plastic surgeon Dr. D.J. Verret of Innovations Facial Plastic Surgery, Texas, USA, reported certain botox alternatives like temporary fillers such as hyaluronic acid can erase the lines by filling in the depression, or Surgiwire procedure can repair skin wrinkles and lines.

Baxter’s multiple-dose vial Heparin causing allergy

Baxter’s Multiple-dose Vial Heparin Linked to Severe Allergic Reactions. FDA advises health care practitioners to switch suppliers and limit use of drug until problem identified. – The U.S. Food and Drug Administration announced today that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable blood-thinning drug heparin due to reports of serious allergic reactions and hypotension (low blood pressure) in patients who receive high “bolus” doses of the drug.

First decellularized heart valve approved in US

The U.S. Food and Drug Administration cleared for marketing the first replacement heart valve from donated human tissue in which the cells have been removed. – CryoLife, Inc., (NYSE: CRY) a biomaterials, medical device and tissue processing company, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its CryoValve(R) SG pulmonary human heart valve processed with the Company’s proprietary SynerGraft technology.

Baby personal care products safer for infants

Statement by John Bailey, Chief Scientist: The Personal Care Products Council Response to Study on Phthalate Exposure in Baby Care Products.
– A study published this month in the journal, Pediatrics, suggests that the use of baby lotion, powder, and shampoo is linked to the presence of phthalates in babies. Phthalates are a large family of compounds used in a wide variety of everyday products.

Pfizer’s anti smoking Chantix latest safety information

Pfizer’s anti smoking Chantix latest safety information

The U.S. Food and Drug Administration (FDA) issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. – Chantix (varenicline), a prescription medication used to help patients stop smoking reported to have certain adverse effects like changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior. US FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers.

Suicidal thoughts and behaviours from epilepsy drugs, alerts Medsafe

Medsafe, New Zealand’s Ministry of Health’s medicines regulatory arm, is alerting health care professionals in New Zealand about a small increased risk of suicidal thoughts and behaviours in patients taking anti-epileptic medicines. – Medsafe, New Zealand’s Ministry of Health’s medicines regulatory arm, is alerting health care professionals in New Zealand about a small increased risk of suicidal thoughts and behaviours in patients taking anti-epileptic medicines.

Allergan confirms fatality not caused by Botox cosmetic

Allergan, Inc. responds to Public Citizen’s allegation regarding a fatality following BOTOX(R) Cosmetic Treatment. – In response to public reports suggesting a causal link between a BOTOX(R) Cosmetic treatment in 2003 and a fatality, Allergan, Inc. (NYSE:AGN) provided further assurance to patients and the public about BOTOX(R) Cosmetic and BOTOX(R) (Botulinum Toxin Type A).

Ongoing review of cholesterol drug Vytorin

FDA issues early communication about an ongoing review of vytorin, and advises patients to talk with their health care providers if they have questions about the ENHANCE study. – The U.S. Food and Drug Administration (FDA) is informing the public that the agency will conduct a review of Merck and Schering Plough’s recent trial once the FDA receives the final study results.

Stricter warnings for botox, myobloc botulinum injections

Botox and a similar injection Myobloc should come with stronger warnings following reports of 16 deaths after the botulinum toxin spread inside the body, a U.S. consumer group Public Citizen said.
– The Food and Drug Administration (FDA) should immediately increase its warnings and directly warn patients and doctors about the use of botulinum toxin ? available as Botox and Myobloc ? because of serious adverse reactions, including deaths, linked to the drug, Public Citizen said in a petition filed with the FDA.

NEJM Antidepressant’s Publication study may discourage depressed people

Mental Health America response to New England Journal of Medicine Study, “Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy”. – Mental Health America notifies the potential harm of the NEJM’s Selective Publication of Antidepressant Trials study that it may discourage people with depression from seeking appropriate care and evidence-based treatments that work for them. Mental Health America is one of America’s leading mental health advocacy groups.