Category Archives: Drug Side Effects

Efavirenz, compound in Atripla Credit: Fvasconcellos via Wikimedia Commons Gilead Sciences announced on Monday that Stribild, a four-in-one combination HIV treatment in a single pill, received FDA approval. In clinical trials submitted to the FDA, the drug was found to be as effective as Atripla and has the advantage of fewer side effects. But Stribild has a substantially higher price than current HIV combination drugs. Gileads stated wholesale price of Stribild as $28,500 per patient, per year has created controversy since before its release. Democratic members of Congress sent a letter to dated August 1 urging Gilead to use sustainable pricing that would not burden the AIDS Drug Assistance Program. Andrew Weinstein, president of AHF, stated to the New York Times that Gileads pricing of Stribild shockingly irresponsible. Gilead maintains that Stribild pricing is comparable to other HIV medications on the market. Stribild is priced at 39 percent higher than Complera, a three-drug HIV regimen approved only one year ago.At the time of Compleras approval, there were concerns about the $20,500 wholesale cost of Atripla, which is marketed by Gilead and Bristol-Myers Squibb. HIV drug prices have increased substantially, even during the current economic downturn. Atripla, a combination therapy released … Continue reading →

Lastman Muthko lies at a Mdecins Sans Frontires hospital in the Upper Nile in South Sudan in July.(Nichole Sobecki, AFP) A single anti-malarial pill with no side effects that blocks transmission of the killer disease could soon be available, University of Cape Town scientists announced this week. Based on a recently discovered chemical compound, the cure could deal with many of the shortcomings that have prevented an effective treatment for the infectious disease that, according to the World Health Organisation, kills a child in Africa every minute. Professor Kelly Chibale, project leader at the universitys Drug Discovery and Development Centre, said very low doses of the treatment had proved effective in animal tests. It was now ready for preclinical development and human clinical trials were expected to start next year. A new drug was needed because the treatments currently available have shortcomings that range from negative side effects to resistance and noncompliance, he said. Our compound has the potential to kill off a number of drug-resistant strains of malaria in Africa and Asia, as well as improve compliance, given the potential single-dose administration. Named the MMV390048 molecule, the compound was designed, synthesised and evaluated in a record 18 months in … Continue reading →

The most common side effects observed in patients with SEGA were mouth ulcers and respiratory tract infections. Afinitor Disperz is recommended to treat patients ages 1 year and older with tuberous sclerosis complex (TSC) who are diagnosed with SEGA that cannot be treated with surgery. Prior to approval of this new dosage form, Afinitor was recommended for use only in patients ages 3 years old and older. Afinitor was granted accelerated approval in 2010 to treat SEGA in patients with TSC. Appropriate pediatric dosage forms, such as Afinitor Disperz, help to ensure the safe and effective use of oncology drugs in children, said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDAs Center for Drug Evaluation and Research. In addition, todays approval demonstrates the value of further studying a drug to better characterize its benefits and how it should be used in pediatric patients. Afinitor Disperz is available in smaller dose increments than the adult dosage form, Afinitor. Afinitor Disperz also dissolves easily in a small volume of water, making it easy to administer to patients who are unable to swallow whole tablets to take their medication. Afinitors manufacturer, Novartis, also provided updated safety and … Continue reading →

Posted by Eric ChaffinAugust 29, 2012 10:00 AM Patients in the United States are not the only ones experiencing serious side effects from the diabetes drug Actos. Canadian resident Jimmy Whyte filed a new class action lawsuit on behalf of individuals who suffer from bladder cancer as a result of taking Actos. Whyte claims that Takeda Pharmaceuticals, the manufacturer of Actos, failed to adequately warn of the risks and put thousands of patients in danger. The FDA approved Actos for treatment of type II diabetes in 1999. The drug was cleared for the same use in Canada in 2000. Since then, hundreds of plaintiffs have come forward to file a lawsuit seeking to hold Takeda Pharmaceuticals liable for their Actos related injuries. Plaintiffs Claim Takeda Failed to Warn of Bladder Cancer Like other plaintiffs who have suffered from Actos bladder cancer, Whyte alleges that it would have been important to know that the drug could increase his risk of the disease prior to taking Actos. In 2008, there were no warnings on the label concerning bladder cancer. In September 2010, the FDA released a public safety communication stating that it was looking into a potential connection between Actos and bladder … Continue reading →

Everyone over 50 should take cholesterol-lowering statins, regardless of their medical history, a leading heart expert has said. British cardiovascular expert Professor Sir Roy Collins dismissed fears raised by U.S. and U.K regulators that the cholesterol lowering drug causes dangerous side effects such as memory loss, depression and sexual dysfunction, saying the benefits far outweigh any potential complications. "There is an argument being made that if we start treatment earlier and continue for a longer time then the benefits will be much greater," Sir Rory said during a keynote address at the European Cardiology Congress in Munich on Tuesday, according to the Daily Telegraph. "You are not trying to un-fur arteries, you are preventing them from furring in the first place." "If you start at a younger age, then if you keep on with the treatment you may get more benefit than if you wait. I think the age of about 50 is the age to start thinking about it." Follow us Statins cut the risk of heart attacks and strokes by a third. The news comes as pharmaceutical giant Pfizer is alleged to be considering a strategy to sell its cholesterol reducer-blockbuster drug, Lipitor, as an over-the-counter (OTC) pill. … Continue reading →

TUESDAY, Aug. 28 (HealthDay News) -- The breast cancer drug tamoxifen may reduce some of the side effects caused by hormone therapy for prostate cancer, according to a new study. Androgen-suppression therapy is often used to slow the progression of advanced prostate cancer. But these drugs, which block testosterone activity, can cause side effects such as breast enlargement and pain that may stop men from using this treatment. German researchers examined the results of four independent clinical trials that examined the use of tamoxifen to manage these side effects in prostate cancer patients undergoing androgen-suppression therapy. The study found that tamoxifen reduced the risk of breast enlargement and breast pain in men at three, six, nine and 12 months of treatment compared to men who did not take tamoxifen. Overall, tamoxifen was more successful in reducing breast symptoms than radiation therapy or treatment with the aromatase inhibitor anastrozole, which is also used to treat breast cancer. Few of the men treated with tamoxifen stopped taking their medication during their year of treatment. Tamoxifen caused no significant side effects, according to the researchers. The study appeared online Aug. 27 in the journal BMC Medicine. "Not all men will suffer [breast enlargement] … Continue reading →

If your man is undergoing treatment for prostate cancer, you know that the feminizing side effect of breast enlargement can play havoc with his male ego. Although he's surely glad to be a survivor, he would just as surely welcome relief from the dreaded "gynecomastia." Now, Germans researchers hold out hope that tamoxifen, the drug frequently prescribed for breast cancer patients, may bea "potential management option for gynecomastia and breast pain due to non-steroidal antiandrogens." The authors, led by Frank Kunath, published their findings in BMS Medicine. They reviewed four key studies and concluded that the currently available evidence "suggests good efficacy of tamoxifen for the prevention and treatment of breast events induced by non-steroidal antiandrogens. The impact of tamoxifen therapy on long-term adverse events, disease progression and survival remains unclear. Further large, well-designed RCTs, including long-term follow-ups, are warranted. Also, the optimal dose needs to be clarified." A journal news release quotes Dr. Kunath as saying: "Not all men will suffer gynecomastia during anti-androgen therapy. However, if men know that there is a successful option for reducing the breast symptoms associated with treatment for prostate cancer they may be more likely to see their doctor when symptoms of cancer … Continue reading →

Cancer Health Home>>Cancer>>Health news Written by: QMI Agency Aug. 28, 2012 A widely used breast cancer drug may ease the side effects of prostate cancer treatment, according to a new German study. (FOTOLIA) A widely used breast cancer drug may ease the side effects of prostate cancer treatment, according to a new German study. Scientists examined four studies involving men in Europe and North America undergoing drug therapy for prostate cancer, the common side effects of which are gynecomastia (breast enlargement) or breast pain. Those side effects are the most common reasons men stop treatment, said the researchers, who come from medical centres in Nuremberg and Freiburg. The study found that men were less likely to suffer from so-called breast events when their therapy was supplemented with tamoxifen. At 12 months after treatment, men were 22% less likely to have breast enlargement and 25% less likely to have breast pain compared to those taking a different preventative drug, anastrozole. However, while tamoxifen showed "good efficacy" for the prevention and treatment of breast events, more research is needed. "The impact of tamoxifen therapy on long-term adverse events, disease progression and survival remains unclear," the researchers wrote. "Also, the optimal dose needs … Continue reading →

Men undergoing prostate cancer treatment commonly suffer side effects such as the growth of breast tissue or breast pain, but the breast-cancer drug tamoxifen may reduce the risk of these effects, a new review says. Researchers looked at four studies of men withprostate cancer, and found that men whose treatments were supplemented withtamoxifenwere less likely to have breast enlargement and breast pain than those not taking the drug. For instance, six months after starting treatment, men who took tamoxifen were 10 percent less likely to have breast enlargement and 6 percent less likely to have breast pain compared with patients not receiving the drug, which counteracts the effects of estrogen on breast tissue. Tamoxifen prevented these side effects about 20 percent better than other treatments, such as the drug anastrozole, which counteracts estrogen's effects in a different way, the researchers found. The growth of breast tissue and breast pain has been cited as reasons why men stop their prostate cancer treatments, according to the study. "If men know that there is a successful option for reducing the breast symptoms associated with treatment for prostate cancer, they may be more likely to see their doctor when symptoms of cancer first appear, … Continue reading →

ZURICH (Reuters) - Swiss drugmaker Roche Holding AG said its "armed antibody" T-DM1 drug significantly extended the lives of women with an aggressive type of breast cancer compared to those receiving the standard drug cocktail. Breast cancer, the most common cancer among women worldwide, will afflict about 1.4 million women worldwide and more than 450,000 women will die of the disease annually, according to the World Health Organization's International Agency for Research on Cancer. Roche said its Genentech unit will soon submit a marketing application to the European Medicines Agency for trastuzumab emtansine (T-DM1) and has already applied for a license with the U.S. Food and Drug Administration. Roche said the EMILIA study of the drug had now met both primary efficacy endpoints of significant improvements in overall survival and progression-free survival, adding it will present the data at an upcoming medical meeting. Roche, the world's largest maker of cancer drugs, has been developing T-DM1 as a successor to its blockbuster Herceptin, its third-biggest seller, which could be exposed to so-called "biosimilar" generic competition in Europe from around 2015. The trial for women with breast cancer known as HER-2 positive - which makes up about a fifth of all breast … Continue reading →