The Combustion Zone

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Blog 4 - PRNewswire Article

FDA issues warning letter to drug company Alkermes, Inc. over failing to identify all the risks of its drug Vivitrol in an advertisement

The Food and Drug Administration has issued a warning letter to Alkermes, Inc. for misbranding its drug Vivitrol by omitting warnings about the most serious risks of the drug from promotional materials. Vivitrol is approved for treatment of opioid dependence by preventing relapse following opioid detoxification. The FDA issued the warning letter because of a print advertisement for Vivitrol. While the advertisement goes over the benefits of Vivitrol, it failed to adequately communicate the precautions and risks that the drug may possess. The most serious being a potentially fatal vulnerability to opioid overdose. "One way the FDA protects the public health is by ensuring that prescription drug information disseminated by drug sponsors is truthful, balanced and accurately communicated. We do this by reviewing prescription drug advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading," said Thomas Abrams, director of the FDA's Office of Prescription Drug Promotion in the FDA's Center for Drug Evaluation and Research. "Vivitrol is being promoted in a way that does not adequately present important risk information in a truthful and non-misleading manner. This is concerning from a public health perspective because of the potential for fatal opioid overdose in this vulnerable patient population." Because of this, the FDA is requesting that Alkermes, Inc. immediately cease anything that mislabels the product. It also requested that the company implement a comprehensive plan of action for making sure that anyone that received the mislabeled promotional materials are adequately informed of all the truthful, complete information. Specifically the materials fail to communicate that patients being treated by Vivitrol may experience reduced tolerance to opioids after taking Vivitrol. The drug works by blocking the effects of opioids, and the drug’s effect lasts 28 days. As the effect wanes and eventually clears, and if patients are taking opioids as this clearing is occuring, it may lead to patients responding to lower doses of opioids than they did before. Thus if they then take an opioid in the same dosage they used before Vivitrol, it may lead to an overdose. There is also a possibility that someone taking Vivitrol may overcome the drug’s effect blocking opioids. The materials also fail to address a few other risks including injection site reactions, and other common adverse reactions. The FDA has also requested that Alkermes, Inc. issues a written response to their warning letter by Dec. 16th.

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Cover an Event Assignment

Do you enjoy watching movies? Do you enjoy watching movies for free? Then you should check out the monthly LACM Classic Film Screenings held by the head of the Communication department, Timothy Skinner.

The LACM Classic Film Screenings occur in lecture hall Room 102, in Titchener Hall at 4pm. The event runs until about 6pm. Four movies are shown during the semester, three movies with sound and one silent film. The films are chosen from the American Film Institute’s list of Top 100 movies of all time. This month’s movie was the silent film, “Modern Times” by Charlie Chaplin. While the movies shown in the previous months were “Star Wars (1977)”, and a Double Feature of “Frankenstein” and “Bride of Frankenstein”. Next month’s movie is “The Godfather” and it’ll be shown on December 6th. 

The event is organized by Professor Skinner. When questioned on why he began this event Professor Skinner replied “I hope to give students a better appreciation for film, and to help them realize that films aren’t just slapped together.”. Professor Skinner also believes that this event will be helpful to students who major in Communications. He hopes watching these films will give Communications students a better appreciation for the craft. And he believes that by watching these films and learning how the filmmakers achieved various effects and the shots that they did will make them better Communications students.

Another attendee of the event was Nick Faiella who was attending the Film Screenings for a film analysis class he is taking. He stated that he greatly enjoyed Chaplin’s “Modern Times”. And when asked what his thoughts of the Screenings were he stated “It’s definitely something I’d consider going to again.”. 

Therefore if you’re a fan of classic movies or maybe if you’ve never seen them before, you should definitely stop by the LACM Classic Film Screenings to watch next month’s movie. They’re gonna make you an offer you can’t refuse.

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Feature Story Assignment

Would you be able to survive a fire? Justin was forced to find out the answer firsthand after an explosion in his home that caused a fire. He was in his freshman year of highschool at the time. Justin and his family smelled gas the night of fire. The odor seemed to be coming from the garage and Justin’s parents went down to check it out. The children ran down after their parents, due to being curious about where they were going, when suddenly there was a bright flash. The explosion, and subsequent fire, gave Justin multiple severe burns and collapsed his lungs. Doctors were forced to put him in a medically induced coma for two months so they could fix his lungs. Justin was also given skin grafts to heal the burns from the fire. He still has the scars and some bald spots to this day. When Justin was finally awoken from the medical coma, he was forced to go through physical therapy to learn how to walk again. It was estimated by doctors that it would take two months for him to do so. Justin managed to complete the rehabilitation in only one month. He also had to visit therapists to help him deal with the trauma. The tragedy further gave Justin a more realist, cynical view of the world. Though it’s not all entirely bleak. Justin has said that since it happened he’s largely dealt with the trauma from the event and it’s now something he’s able to freely talk about and discuss. And it’s also given him a desire to do volunteering, so he can help others going through hard times.

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Updates from Destiny: New Light

The long-awaited release of the Free-To-Play version of Destiny 2, Destiny: New Light, has finally occurred and it has brought along with it a whole host of updates to various game features. The biggest change is the Destiny armor system’s new Armor 2.0. Whereas before the update armor came with random perks, Armor 2.0 allows you to unlock and slot perks of your choosing. This allows players to tailor their armor specifically to their own playstyle.  And while Armor was changed the most, Weapons did receive some updates of their own. For instance, Weapon Mods are now reusable unlocks. Any mods in the player’s inventory prior to the update were automatically unlocked for that player. Unfortunately this does not apply to mods already equipped on weapons, and those mods will need to be acquired again. New Light also added new Finisher moves to the list of Guardian abilities. Finishers can be used to kill weakened enemies with a stylized melee attack. A symbol will appear over an enemy’s head, indicating that a finisher can be used on them. Also changing is how Black Armory forges are utilized. Forges are now on a daily rotation and can be accessed directly from orbit. Weapon Frames are also no longer locked to specific forges, and can be run through any of them. New Light also added a new Nightfall strike activity known as Nightfall: The Ordeal which will allow players to more easily obtain Exotics. The higher the difficulty of The Ordeal that is done, the increased chances of an exotic drop. The first two tiers of the activity also possess matchmaking, pairing a player’s Guardian up with two other random players. The final two tiers of the activity unfortunately does not possess this, so players will need to put together or find their own fireteams.