US Re-examines Merck's Singulair Patent.
Merck &Co. (Whitehouse Station NJ) said the
U.S. Patent Office is reexamining the patent on its biggest product, $4.5
billion-a-year asthma treatment Singulair. The U.S. Patent and Trademark
Office (PTO) ordered the reexamination on May 20, according to PTO records.
It did so after a request by a new online community called Article One
Partners LLC (New York) that recruits scientists worldwide to look for
evidence patents have been improperly issued
Possible drug, suicide link probed, FDA looks into
reports involving best-selling Singulair by Merck
WASHINGTON - The Food and Drug Administration
said Thursday that it is investigating a possible link between Merck's
best-selling Singulair and suicide.FDA said it is reviewing a handful of
reports involving mood changes, suicidal behavior and suicide in patients
who have taken the popular allergy and asthma drug.Merck has updated the
drug's labeling four times in the past year to include information on a
range of reported side effects.
Merck Statement in Response to the FDA's June 12, 2009
Communication with Updated Information on Leukotriene Inhibitors, Including
SINGULAIR®(montelukast sodium)
Merck &Co., Inc. issued the following statement
in response to today's communication from the U.S. Food &Drug Administration
(FDA) addressing updated information on leukotriene inhibitors, including
SINGULAIR®(montelukast sodium). Since the introduction of SINGULAIR in
1998, the Company has updated the post-marketing section of the prescribing
information to communicate a range of adverse events reported with post-marketing
use of Singulair.
FDA Investigates Merck's Singulair for Suicide Risk.
Merck &Co.'s (Whitehouse Station NJ) Singulair
may be linked to suicide as well as changes in mood and behavior, the Food
and Drug Administration said in announcing a review of the company's top-selling
asthma drug. FDA said it is working with Merck to evaluate studies and
patient reports, the agency said in a notice on its Web site. The examination
may take as long as nine months. The company declined to say how many deaths
were reported.
Singulair's label updated with growth data
Merck said Tuesday it has updated asthma drug
Singulair's label to show kids on the drug have normal growth rates. Merck
said in a statement that the new labeling will reflect the results of a
56-week study of Singulair showing that children with asthma from age 6
to 8 years taking the Singulair 5 mg tablets once per day had similar growth
rates as children getting placebo.Merck's study counters other scientific
data suggesting that long-term use of Singulair stunted growth in children.
Mentor mom helped wage fight on Singulair
It's one of the most popular medicines in America
- last year, pharmacists filled about 28 million prescriptions for it.So
chances are good that you or someone you know is taking Singulair.What
you may not know is that hundreds of people taking the allergy and asthma
medication have reported frightening side effects, including depression,
hallucinations and suicidal thoughts. Word is spreading now.
FDA strengthens warning on popular asthma drugs,
Singulair, others could cause psychiatric problems
WASHINGTON - New labels on popular asthma drugs
including Merck's Singulair must highlight language about suicidal behavior,
depression and anxiousness seen in a small number of patients, federal
regulators said Friday.After 15 months of investigation, the Food and Drug
Administration said Merck &Co. Inc., AstraZeneca and Cornerstone Therapeutics
will have to raise label warnings about psychiatric problems reported by
a handful of patients taking their medicines.
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