Recent FDA Alerts on
Drug Products                   
zhion, March 2005
Vioxx (rofecoxib) 09/2004

- Increased Risk of Cardiovascular Events

Merck & Co., Inc. withdrew Vioxx (rofecoxib) from the market due to
safety concerns of an increased risk of cardiovascular events (including
heart attack and stroke) in patients on Vioxx.  Vioxx is a prescription
COX-2 selective, non-steroidal anti-inflammatory drug (NSAID).

Adderall and Adderall XR (amphetamines) Information [2/9/2005]

- Sudden Deaths in Children

Health Canada has suspended marketing of Adderall XR products from
the Canadian market due to concern about reports of sudden
unexplained death (SUD) in children taking Adderall and Adderall XR.  
SUD has been associated with amphetamine abuse.

Natalizumab (marketed as Tysabri)  Information [02/28/2005]

- One fatal Case and One Additional Case of Progressive  
Multifocal Leukoencephalopathy

After confirmation of one fatal case and one additional case of
progressive multifocal leukoencephalopathy (PML) in patients receiving
Tysabri for multiple sclerosis (MS), Biogen-IDEC has suspended
marketing of Tysabri and all further dosing of patients in on-going
clinical trials. Both patients had been taking Tysabri for more than two
years and there were no no previous cases of PML reported.

Rosuvastatin Calcium (marketed as Crestor) Information [03/2005]

- Risk for Serious Muscle Toxicity and Kidney Failure

Rhabdomyolysis (serious muscle damage) has been reported in
patients taking Crestor as well as other statin drugs. Its label is being
revised to highlight important information on the safe use of Crestor.   In
addition, patients who are candidates for statin therapy (e.g., patients
with diabetes, hypertension, atherosclerosis, and/or heart failure) may
also be at higher risk for kidney failure even when they are not taking
statins.

Tacrolimus (marketed as Protopic Ointment) Information [03/2005]

Potential Cancer Risk

The FDA has issued a public health advisory to inform healthcare
professionals and patients about a potential cancer risk from use of
Protopic (tacrolimus).

Pimecrolimus (marketed as Elidel Cream) Information [03/2005]

Potential Cancer Risk

The FDA has issued a public health advisory to inform healthcare
professionals and patients about a potential cancer risk from use of
Elidel (pimecrolimus).

NOTE THERE MAY BE NEWER ALERTS ON THESE DRUG PRODUCTS. YOU SHOULD
KEEP AN EYE ON
DAILY NEWS.THE ABOVE INFORMATION IS FOR YOUR
REFERENCE ONLY.
YOU SHOULD CONSULT YOUR DOCTOR FOR ANY QUESTIONS.

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