Federal regulators have signed off
on a redesign for the labels of a number of Merck drugs, including
Zocor, Propecia, Januvia and a dozen other drugs, to improve
readability and reduce the risk of medication mistakes and
prescription errors.
The FDA announced its approval for a new standardized format last
week, after Merck proposed a revisions to the container labels for
16 solid oral drug products. The new labels are designed to provide
better information to help differentiate the products and strengths
of the various drugs.
The new label designs will affect the following Merck drugs: Cozaar,
Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin,
Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and
Zolinza. The labels were designed using a scientific approach and
then had to be approved by eight different divisions of the FDA’s
Center for Drug Evaluation and Research (CDER).
The FDA has asked health care providers to report any medication
errors involving the new labels so that the agency can properly
grade and monitor their effectiveness. Merck label medication errors
should be reported to the FDA’s MedWatch adverse event reporting
program.
The new label design standardization was approved at the end of a
week in which the FDA announced new warnings about potential health
problems with several of the Merck drugs included in the project,
including Zocor, Propecia and Proscar. However, there is no
indication that the timing of the announcements were related.
On June 8, the FDA recommended that no new patients be started on an
80 mg Zocor (simvastatin) regimen, due to the risk of myopathy,
rhabdomyolysis, kidney damage and other muscle injury. Zocor is one
of Merck’s best-selling medications, which is also widely avaiable
as generic simvastatin.
Rhabdomyolysis from Zocor causes muscle fibers to begin to break
down, releasing a protein called myoglobin, which can damage the
kidneys as they attempt to filter it out of the bloodstream.
Symptoms of rhabdomyolysis include muscle cramps, tenderness,
stiffness, pain or spasms. The illness is usually reported in
patients over 65 years of age or those who have renal impairment or
uncontrolled hypothyroidism.
On June 9, the FDA issued a drug safety alert for Propecia, Proscar
and similar drugs, warning that the hair loss and enlarged prostate
treatment drugs could increase the risk of the more serious forms of
prostate cancer.
Propecia (finasteride) was approved in 1992 for the treatment of
benign prostatic hyperplasia, and also is approved to treat male
pattern baldness. It was originally marketed by Merck as Proscar.
In addition to cancer concerns, researchers from the U.S. published
a study in the Journal of Sexual Medicine in March that found side
effects of Propecia and similar drugs were linked to sexual problems
in men. Researchers indicated that 5-alpha-reductase inhibitors can
cause loss of libido, depression erectile dysfunction, reduced semen
production and growth of male breast tissue. They also agreed that
in some cases these side effects appeared to be permanent.
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