FDA MedWatch Safety Alerts

Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).

FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

FDA requires risk management plan and class-labeling changes for all LABAs.

Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.

Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.

FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.

Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Device may not be able to deliver therapy during a cardiac resuscitation attempt.

Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.

Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.

Clinicians should consider the potential long-term risks when prescribing to adolescents.

Risk information added to Warnings/Precautions section and data summary provided

Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.

Plastic centrifuge rotor may crack, break apart and be forcefully ejected.

Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted.

Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.

UPDATE [01/23/2010] Previous alert updated with information on laboratory analysis of sibutramine levels in counterfeit product - Product sold over the internet contains controlled substance sibutramine.

Needles may become detached and remain in the skin.

Contraindication to use in patients with history of cardiovascular disease.