FDA Alerts
FDA Approves Label Changes for Antimalarial Drug Mefloquine Hydrochloride
The US Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride.
FDA Limits Usage of Nizoral (Ketoconazole) Oral Tablets
The US Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications.
FDA Alerts Companies to Stop Illegal Sale of Treatments for Diabetes
The US Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.
FDA Approves Label Changes to Blood Pressure Medicine Olmesartan Medoxomil
The US Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.
FDA Takes Action to Protect Consumers from Dangerous Medicines Sold by Illegal Online Pharmacies
The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.
FDA Obtains Waiver from European Commission to Facilitate Export for US Pharmaceutical Manufacturers
The US Food and Drug Administration announced today that the US is now a “listed” country with the European Commission (EC) so that US companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.
FDA Approves Plan B One-Step Emergency Contraceptive for Use Without a Prescription
Today, the US Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.
FDA Investigating Two Deaths Following Injection of Zyprexa Relprevv
The US Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).
FDA Approves new Silicone Gel-filled Breast Implant
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
FDA Announces Import of Injectable Nutrition Drugs
The US Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.