In terms of pharmaceutical controversies and advances,
2012 was a busy year. Many prescription drugs made headlines this year—sometimes for offering a chemical hope for chronic conditions, and sometimes for putting at risk the lives of those who relied on them to heal and feel better.
These are the most controversial and talked about prescription drugs of 2012.
Stribild, the new HIV treatment pill
On August 27, the FDA approved a new combination prescription drug to combat the HIV virus. Stribild, manufactured by Gilead Sciences, combines four medicines and is administered as a once-a-day treatment.
Studies, reported the Associated Press, show that almost 90 percent of HIV positive patients who take Stribild significantly lower their level of virus in the blood after 48 weeks of treatments.
Truvada, first prescription drug for HIV prevention
Also in August of 2012, the FDA approved Truvada, a prescription drug already used in treating HIV-positive patients, as a preventative treatment to protect against the virus. Manufactured by Gilead Sciences, Truvada is used for healthy people who are considered at high risk of acquiring HIV virus.
Studies show that taken once a day, and combined with safe sex practices, Truvada significantly reduces a person’s chances to acquire the virus.
Although a sign of hope in the fight against AIDS and HIV, controversy soon emerged around Truvada because of the high costs associated with it. In the United States, use of Truvada is around $14,000 per year.
Pradaxa, the lethal blood thinner
Manufactured by Boehringer, Pradaxa entered the U.S. market in 2010, as a blood thinner for preventing strokes and blood clots. Since then however, Bloomberg News reports the drug has been linked to more than 500 deaths in the United States alone and several other health complications.
There are currently more than 150 law suits pending against the pharmaceutical company due to its deadly side effects, which include internal bleeding and cerebral hemorrhage
NECC steroids and the meningitis outbreak
At the top of health news of 2012 was the tragic fungal meningitis outbreak in Massachusetts this fall, which has been tracked down to a vial of injectable steroids shipped from the New England Compounding Center (NECC). Although the steroids injections were not to blame for the dozens of deaths and hundreds of reported cases, but rather the poor handling by the pharmaceutical company, the events led to a national discussion on the dangers of compounding pharmacies and prescription drugs distributed by them.Eventually, the NECC was shut down and their products recalled.
Controversial flu vaccine
Is the flu vaccine worth the shot? That seems to be a yearly dilemma. About 20 percent of the population in the United States suffers from the flu every year and from these about 3,000 to 49,000 die.
According to studies, the flu vaccine can only offer moderate protection against the flu, especially because there seems to be a different strain of the disease every year, which makes it difficult to develop a vaccine that will keep on working.
There has also been controversy about how safety the flu vaccine is in itself, especially for vulnerable groups such as seniors, children and those with depressed immunity.
According to FDA reports, “Over the past several years, because of an increasing awareness of the theoretical potential for neurotoxicity of even low levels of organomercurials and because of the increased number of thimerosal-containing vaccines that had been added to the infant immunization schedule, concerns about the use of thimerosal in vaccines and other products have been raised.”This is one health news we are expecting to continue making headlines in the next year.
Bupropion, generic Wellbutrin, not safe
Optimized Generic Wellbutrin (Bupropion)—used to treat major depressive disorder and seasonal affective disorder—was pulled off market in early December by the FDA due to safety concerns.Bupropion is manufactured by Impax and marketed by Teva. Analysis showed the generic form of the drug in the 300 mg dose, was not bioequivalent to its Wellbutrin counterpart, which put the generic drug efficacy in doubt.
According to the FDA, the efficacy of bupropion was not the only issue, and reports of adverse effects had begun to surface within the agency. The agency explained some people taking bupropion complained of fatigue, anxiety, headaches, and worsening depression symptoms; symptoms which improved once patients were switched back to brand name Wellbutrin.
Qsymia and Belviq, the weight loss miracle
In July 2012, obesity got a knockout punch—or so it seemed. The FDA approved two new weight loss and anti-obesity pills. One of them was Qsymia, manufactured by Vivus Inc.Research showed that study participants who took Qsymia for a year lost between 6 and 11 percent of their total weight.The prescription drug is a combination of two older drugs long known to help with weight loss: phentermine and topirimate.
In late June, FDA also approved Arena Pharmaceutical’s pill Belviq, despite having previously rejected the drug in 2010 after claims it caused birth defects if taken by pregnant women. After approval, FDA released a warning that Belviq should not be taken by patients at high risk of cardiovascular disease.
Besides their proven results, these two drugs made headlines because they are the first and only weight loss pills to be approved by the FDA since 1999.
Provigil, Viagra for the brain
Provigil, a prescription drug for use in narcolepsy cases, made headlines in 2012 after ABC News reported several successful business people in the United States were taking it in order to stay alert, creative and productive.
Provigil’s active ingredient Modafinil, according to the National Library of Medicine “alters the natural chemicals in the region of the brain associated with sleep and wakefulness.”
“[Provigil] can be the difference between I’m just making it through the day to I had the best day of my life,” said Dave Asprey, an executive of a billion-dollar Internet security firm. He told ABC News he once took a 20-hour flight with little sleep, took Provigil, and was still able to deliver speeches of high enough quality to get him mentions in local papers.
No studies have been done on the effects of Provigil on healthy brains, and the effects of long-term use are yet unknown. However, experts do warn about the multiple side effects associated to this prescription drug.
Zithromax, mind your heart
In early May, reports appeared relating Zithromax to sudden deadly heart problems. An antibiotic used for common infections such as bronchitis, Zithromax or azithromycin, has been increasingly popular despite its higher cost, because of the reported quicker results it offers.
Marketed by Pfizer Inc., Zithromax has not been pulled out of the market by the FDA, and no official warnings were immediately made by the agency, although the pharmaceutical company announced it would review the 14-year-long study that raised concerns.
In June 2012, the FDA required new safety labeling for this prescription drug, warning that it “may cause changes in the electrical activity of the heart—specifically, prolongation of the QT interval, a measure of the heart’s electrical activity—and can lead to a potentially fatal abnormal heart rhythm called Torsades de Pointes.”
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In terms of pharmaceutical controversies and advances,
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