The Food and Drug
Administration have advised all patients on Friday to continue taking a widespread
cholesterol drug even though there had been concerns that the drug might
contain specks of glass, retreating advice it gave just a day earlier. Millions of people are taking Ranbaxy
Pharmaceutical's generic Lipitor, or atorvastatin, and numerous have been
calling the pharmacies because they were confused about whether or not to take
the drugs in which they have in their medicine cabinets. Ranbaxy originated a recall on November 9 and
told all the pharmacies to stop distributing the drug, but gave no feedback to
the clients about what to do with what was in their medicine cabinets. Dr. Janet Woodcock, the director of the FDA's
Center for Drug Evaluation and Research, thought the agency would review how it
handles communication to the public during recalls. It took them some time to think out what was
going on. They realised that they needed to fix their processes a little bit. Between 3 million and 4 million people have taken
Ranbaxy's atorvastatin, according to Ross Muken, who is the senior managing
director at ISI Group. The company has greater than a 40% share of the generic
Lipitor market. The FDA made no public declarations
on the recall until Thursday, when the agency said anxious patients should stop
taking their medicine if their pharmacist established it was from a recalled
lot. After a conference call Friday
afternoon with pharmacies and other groups, the agency decided to change their direction. It caused people to believe that they should
stop taking their medicine. The glass
particles are as small as a grain of sand, she added. Ranbaxy has stopped
making atorvastatin while they investigate how the glass got into the drug,
according to the FDA.
http://www.cnn.com/2012/11/30/health/fda-generic-lipitor/index.html?hpt=he_c2
Showing posts with label Lindsay Bulger. Show all posts
Showing posts with label Lindsay Bulger. Show all posts
Sunday, December 2, 2012
Blog 13 FDA Reversal
Saturday, November 10, 2012
Blog 11 Malala's Story
A serious
incident happened on October 9th, with the shooting of 15-year-old
Malala. In one of the most conservative
parts of Pakistan, gunman stopped the van, which was carrying young Malala.
They ordered that the other girls in the vehicle must identify her. Malala
though had experienced frequent death threats in the past, but was never to
caught up in them. So the girls
eventually pointed her out to the gunmen so that they would not be injured.
Even with that said there was one gunman who opened fire, wounding these three
girls. Two of these girls were lucking having non-life-threatening injuries,
but when the bullets struck Malala, they were aimed at her head and her
neck. The assailants were able to get away
though. Malala was in a terrible condition.
Her uncle had described her as having agonizing
pain and saying how she was unable to stop moving her arms and legs. Doctors were working hard in order to save
her life, then her condition dropped severely.
They did operations in order to remove a bullet from her neck. After her surgery, she was not responsive for
just under three days. A month later, it
is considered a miracle that Malala is alive, a girl who fights for the right
of other girls to get an education, is still living and even more shocking that
she has suffered no major brain or nerve damage. In just over four weeks, Malala has gone from
intensive care in Pakistan, and showing no signs of consciousness to now being
able to walk, write, read and smile again in a hospital in the UK. Outside of her room in her hospital, the world
has turned her into the global symbol for the fight to allow girls everywhere
in the world access to an education. The
United Nations has now decided to declared Saturday, November 10, Malala Day.
This is a day to focus on Malala and all of the other millions of girls like
Malala who are not enrolled in school.
Friday, November 2, 2012
Blog 10 How to Avoid Getting the Flu
Thanks to scientists who are
continuing to work efficiently to reinvent the best ways to fight infectious
bacteria and germs by creating a better flu shot, it's gotten a lot easier than
before to protect yourself. Doctor’s are
really pushing patience to follow their advice so that this can be the year
they do not get the flu. The CDC
recommendations are about 6 months everyone she get a vaccination in order to
prevent getting sick during flu season. Every year over 200,000 people are put
into the hospital due to symptoms, which are linked to the flu, and over
thousands of people die if not treated properly. Just under 18,000 people in 2009, were
estimated to have died due to the H1N1 epidemic. Sabra Klein states that women are more prone
to end up in the hospital with flu symptoms compared to men. This is because men’s bodies are more
susceptible to germs and bacteria unlike women.
The vaccine which is recommended during flu season is to say the least
60% effective; it is not 100% effective but if you did end up getting the flu
after getting the flu shot your symptoms will still be less severe than a
patient who has not had the flu shot because your body would have built up some
immunity. The flu generally gets passed around when people who are infected
sneeze, cough, or just talk, and these germs can even be passes along from up
to six to 10 feet away. A typical person will not get the flu from typing on a
keyboard or pressing an elevator button, but that is how the bacteria can be
passed around that could be the start to the flu. Doctor’s suggest being extra clean, and to
clean public computer or telephones with disinfectant wipes before you use them
so that you will have less of a chance of picking up bacteria, or even using
hand sanitizer after using the telephone or computer. When you are sick rest is
really quite necessary if you want any hope of getting better, researchers have
proved that a person getting more rest is less likely to get sick. As well what you eat can make a huge impact,
you don’t want to eat junk food while you are sick doctor’s recommend eating
healthy so that you can build up your immune system. You should cut back on unhealthy
foods such as candy and chips and eat foods that will enhance your immune
response, such as fruits and vegetables.
Friday, October 26, 2012
Blog 9 Floods in Nigeria
There were fierce floods, which had killed dozens in Nigeria
and had left tens of thousands of local residents as well as crocodiles, hippos
and other water animals washed into peoples homes. Due to the floods, they have left 148 people
dead and have also affected 21 of the 36 states in Nigeria, according to the
Red Cross. These torrential downpours
have caused tremendous wrecks in the villages and the projects over the past
few weeks. About 134,000 people have
currently been affected by the weather in Nigeria and the concern is still
growing about the spread and risks of waterborne diseases affecting the
people. These floods have caused a wreck
in a series of states, which include Bayelsa and Benue. A lot of people have been taken out of their
homes; they have been displaced. Snakes,
crocodiles and hippos have even been displaced as well as the people and are
now ending up in people's homes due to the floods. The bad part is now that nothing has been
fixed about this situation yet; people are still suffering. State officials are still working to create
drainage throughout the rivers. The
officials main goals are being able to help calm down the people who have been
displaced and to also improve on the drainage.
Their hope is that when the drainage is fully equipped, and the flooding
has calmed down to send out more resources to help the people who are
suffering. This flood took all the people by surprise, they will need help from
agencies that are out there that usually help out in disasters such as this
one. This will be a tough challenge for
the people to make sure that everyone is well.
In the state of Benue though, over 25, 000 people have been displaced
after one of their local rivers overflowed.
Nigeria has an incredibly rainy season, which tends to occur between May
and October. These heavy rains are
especially hard on the small communities in rural areas, where drainage is
limited or inconsistent. Within the last
month people of Nigeria were urged to move to higher grounds due to the
flooding of their river. The evacuation mostly affected the states of Niger,
Kogi, Kwara, Kebbi, Anambra as well as Delta.
Friday, October 19, 2012
Blog 8 Drug Manufacturers
There are now morphine cartridges that will
contain up to twice the labeled dose, then regular due to the lack of safety in
the manufacturing business. Manufacturing plants have been slacking off lately
and will proceed to use rusty tools, mold in production areas and will omit the
rule of sanitation not caring about the safety of others. The last couple of
years, the major manufacturers of sterile injectable drugs, which are generally
inspected federal government, have been warned by the food and drug
administration about violating several of the regulation guidelines. Several factories are being shut down due to
this problem, or their production is quite slow due to the fixing of these
problems. There have been countless
numbers of health scares recently in the pharmacies and they all trace these
problems back to the main manufacturers. There has
been a report saying that about 19 people had died from meningitis
in an outbreak due to the New England Compounding Center in Massachusetts.
Supplies of a steroid, methylprednisolone acetate, had become short because
Teva and Sandoz stopped producing it. Manufacturers do note that there are
sterile drugs that are being made such as products like chemotherapy drugs and
anti-seizure drugs like diazepam. These
are sold in the United States and are so far safe, with a large quantity as
well. Since around 2009, regulators have discovered the failures in quality
control at plants in areas such as North
Carolina, California
and Costa Rica. This was the leading cause to several recalls
of products - diverse as broken infusion pumps to overfilled morphine vials. A
company in Rocky Mount North Carolina had to slow down their production and
they were one of the largest manufacturers.
That being said they also experienced the most recalls and problems.
I believe that the FDA should be
looking at drug manufacturers regularly because we are the ones that end up
taking the drugs, which they make, and they should be safe. We should not have to worry whether the medicine
we take to relieve us is safe or not.
These companies don’t follow the FDA regulations and are not sanitary
because they believe it will slow down their production. But in fact if they do keep their
manufacturing business clean more pharmacies will purchase the drugs from them
because they would have passed the FDA inspections, unlike the other
manufacturers.
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