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US FDA Approved New HIV Treatment

A new treatment for HIV has been approved by the US Food and Drug Administration on Friday. The medication is used with other antiretroviral drugs, which blocks the replication of the virus that causes the disease.

TMC278 or rilpivirine is a pill developed by Johnson & Johnson and will be given mainly for patients who have never started treatment for HIV, the FDA said in a report released on Friday. The American pharmaceutical company will sell it in the market under the brand name Edurant. It will be consumed once a day with meals.

According to Dr. Edward Cox, Office of Antomicrobial Products director in the Center for Drug Evaluation and Research in FDA, patients respond variously on the given HIV treatments; thus, the approval of Edurant provides an alternative option for patients who will start its therapy.

Two clinical trials were performed before the new medication was approved. The trials were carried out to 1,368 adults who had not yet received any treatment against HIV. Researchers randomly assigned patients with certain medications, which include rilpivirine, efavirenz and other pharmaceutical products.

In the trials, about 83% of the patients who received the new treatment suppressed the replication of the HIV virus at untraceable levels. Also, the same occurred to about 80% of the patients who have received efavirenz.

The results of the trials showed that rilpivirine works as well as efavirenz, also called as Sustiva by the Bristol-Myers Squibb. Most of the side effects that patients experienced while they took Edurant included headache, rashes, insomnia and depression.

The agency warned that rilpivirine does not cure infections with HIV. It advised that patients must have continuous therapy with the new pill to manage the condition and reduce the risk of spreading the illness.

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Drug Makers Eliminated Infant Drops of Acetaminophen

Johnson & Johnson as well as other makers of a fever medication announced on Wednesday that they will stop producing infant drops for medicines with acetaminophen to avoid confusion that may unfortunately lead to drug overdoses.

The association that handles over-the-counter or OTC drug makers said that all of their members will discontinue liquid drops beginning later this year. After all the drugs have been successfully phased out, drug companies will only market one formula for children age 12 and below.

At present, J&J and many other drug companies sell infant formulations that have half the amount of acetaminophen compared to that found in children’s (1-12 years old) formula.

Acetaminophen is a drug component usually found in Tylenol and Nyquil; it effectively reduces body temperature and pain. Although it is safe to use in general, acetaminophen overdose is one of the leading causes of liver failure in American and it sends as much as 50,000 people to the emergency room every year.

The announcement that was released late Wednesday is in line with the Food and Drug Administration’s meeting with them scheduled on Monday. The meeting was intended for the discussion of the need for additional safety instructions in drugs with acetaminophen.

Drug makers’ move to eliminate infant formula with acetaminophen content marks the second instance that the drug industry pulled off its products before the FDA can act on it. In 2007, the same group of drug makers announced the discontinuation of infant decongestant medicines ahead of an FDA meeting that was supposed to talk about infant deaths related to the product.

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