Category Archives: Drug Side Effects

The Food and Drug Administration doesn't make a habit of giving drugs that once showed serious side effects another shot at approval, but it did so this past Monday. The case in point is not just one medication, but a class of drugs meant to manage the chronic pain of arthritis and other diseases. After a hearing at which drug company representatives argued on behalf of their prospective treatments, an FDA drug advisory panel unanimously voted in favor of recommending that the drugs called anti-nerve growth factors be allowed to continue testing, despite problems encountered two years ago. This was a clear win for Pfizer (NYSE: PFE) , whose drug trial of tanezumab was stopped in 2010 when some trial participants were found to have worsening joint deterioration. Other drug companies have their own versions of anti-NGFs, including Johnson & Johnson (NYSE: JNJ) , Regeneron Pharmaceuticals (Nasdaq: REGN) , which is working in partnership with Sanofi on its entry, and AstraZeneca (NYSE: AZN) . Abbott Laboratories (NYSE: ABT) also has an anti-NGF drug under study, ABT-110, which has finished its phase 1 testing. The company did not attend the hearing. Pfizer's tanezumab seemed like a winner back in 2010, until … Continue reading →

Public release date: 18-Mar-2012 [ | E-mail | Share ] Contact: Bruce Goldman goldmanb@stanford.edu 650-725-2106 Stanford University Medical Center STANFORD, Calif. -- The utility of a naturally occurring protein given, sometimes to great effect, as a drug to treat advanced cancers is limited by the severe side effects it sometimes causes. But a Stanford University School of Medicine scientist has generated a mutant version of the protein whose modified shape renders it substantially more potent than the natural protein while reducing its toxicity. The findings will appear online March 18 in Nature. The protein, known as interleukin-2 or IL-2, is a master regulator of the immune system. It acts as a growth factor for many different kinds of immune cells, including an all-important class called T cells. These cells can both recognize and organize attacks against pathogens or tumors. IL-2 stimulates T cells' proliferation in response to these threats. That makes it a potent anti-cancer drug. When injected into a patient, it spurs fierce anti-tumor activity. "In a substantial subset about 7 percent of patients with advanced metastatic melanomas or kidney cancers, IL-2 treatment actually cures the disease," said Christopher Garcia, professor of molecular and cellular physiology and of structural … Continue reading →

Many patients taking a widely prescribed class of oral cancer drugs are also using a variety of medications that could reduce the effectiveness of the cancer treatment or increase its toxic side effects, according to research by Medco Health Solutions Inc. For example, 43 percent of patients taking the highly effective leukemia drug Gleevec were also on another medicine that could diminish its efficacy, while 68 percent were taking something that could potentially raise the toxicity level, the study found. Not surprisingly, the study found that the vast majority of the cancer drugs were prescribed by an oncologist, while the other medicines were typically prescribed by a primary care physician. "More communication needs to take place across all doctors that are prescribing for the patient," said Medco's Steve Bowlin, who is presenting the study findings on Friday at the American Society for Clinical Pharmacology and Therapeutics meeting in Washington. The Medco drug interaction study looked at pharmacy claims of about 11,600 patients who had been prescribed any of nine oral drugs known as kinase inhibitors, used to treat a variety of cancers. They include Gleevec and Tasigna from Novartis; Pfizer Inc's Sutent; Nexavar from Onyx Pharmaceuticals Inc and Bayer AG; … Continue reading →

WASHINGTON (Reuters) - U.S. drug reviewers questioned whether a sarcoma treatment from Merck & Co Inc and Ariad Pharmaceuticals Inc kept tumors at bay for long enough, given the drug's serious side effects. The drug, called Taltorvic, is meant as a maintenance therapy for people with soft tissue or bone sarcoma who have had four successful rounds of chemotherapy. U.S. Food and Drug Administration staff found the drug stopped cancer from spreading two weeks longer than a placebo, according to FDA documents posted online on Friday. But the drug had serious safety issues, such as kidney failure, infection and inflamed lung tissue, the documents said. About 14 percent of patients discontinued treatment because of side effects, compared with 2 percent of patients who stopped taking the placebo. "The number of patients who discontinued due to an adverse event is of particular concern in a drug intended for use as maintenance therapy," the FDA staff said in the documents. Maintenance therapies help people stay disease-free once their cancer is in remission. There are currently no FDA-approved maintenance therapies for sarcoma. A panel of outside experts to the FDA will vote on whether to recommend approval of Taltorvic on Tuesday, and the … Continue reading →

There's always that part at the end of drug commercials that goes something like: if you develop sausage fingers, webbed feet, or a three-week erection, call your doctor! But as exhaustive as those auctioneer-style lists sound, they barely scratch the surface when it comes to the side effects pople are actually experiencing. Stanford researchers created an algorithm that identified 1,332 drug side effects not currently listed on labels. They estimate that each drug has 329 adverse reactions on average, nearly five times the 69 currently listed. The FDA maintains a database of about 4 million side effects reported by doctors and patients, but no one's sure exactly what causes most of them. That's partly because so many people take more than one drug at a timeseniors take an average of sevenand it's impossible to know how all of the combinations react in each individual. It's also because individuals often react differently to the same drugs. So researchers at the Stanford University School of Medicine wrote an algorithm that sifts through millions of reports and surfaces what they call "true" side-effects. They reported their new method in Science Translational Medicine. One important adverse interaction they turned up was that serotonin reuptake … Continue reading →

(Reuters) - Many patients taking a widely prescribed class of oral cancer drugs are also using a variety of medications that could reduce the effectiveness of the cancer treatment or increase its toxic side effects, according to research by Medco Health Solutions Inc. For example, 43 percent of patients taking the highly effective leukemia drug Gleevec were also on another medicine that could diminish its efficacy, while 68 percent were taking something that could potentially raise the toxicity level, the study found. Not surprisingly, the study found that the vast majority of the cancer drugs were prescribed by an oncologist, while the other medicines were typically prescribed by a primary care physician. "More communication needs to take place across all doctors that are prescribing for the patient," said Medco's Steve Bowlin, who is presenting the study findings on Friday at the American Society for Clinical Pharmacology and Therapeutics meeting in Washington. The Medco drug interaction study looked at pharmacy claims of about 11,600 patients who had been prescribed any of nine oral drugs known as kinase inhibitors, used to treat a variety of cancers. They include Gleevec and Tasigna from Novartis; Pfizer Inc's Sutent; Nexavar from Onyx Pharmaceuticals Inc and … Continue reading →

NEW YORK (Reuters Health) - Epidurals and other drug-based treatments are the tried-and-tested way to ease labor pain, but also have side effects that make them less attractive, according to a new overview of women's options for pain relief during child birth. Alternative methods such as water birth, acupuncture and relaxation techniques may help take the edge off the pain without those risks, but it's still unclear just how effective they are. "It's important for a woman to be aware that there are a number of different measures that can help her," said Dr. James Neilson, an ob-gyn at the University of Liverpool in the UK, who led the new work. While there is no one-size-fits-all, trying a low-risk, drug-free approach first makes sense, he added. "I think there is a lot to be said for starting with simple methods and then working up if necessary," he told Reuters Health. "Clearly there is a lot of variation in the amount of pain that women experience during labor." The new report is published by the Cochrane Collaboration, an international group of researchers that puts medical evidence through a rigorous review process. Neilson and his colleagues decided to take a sweeping look … Continue reading →

Public release date: 14-Mar-2012 [ | E-mail | Share ] Contact: Krista Conger kristac@stanford.edu 650-725-5371 Stanford University Medical Center STANFORD, Calif. -- A week ago, you started a new prescription medication for acne. Today, you feel dizzy and short of breath and have difficulty concentrating. Your symptoms are not listed in the package insert as possible side effects of the drug, but why else would you be feeling so odd? Unfortunately, there's no easy answer. Clinical trials are designed to show that a drug is safe and effective. But even the largest trials can't identify irksome or even dangerous side effects experienced by only a tiny proportion of those people taking the drug. They also aren't designed to study how drugs interact with one another in the human body a consideration that becomes increasingly important as people age and their medicine cabinets begin to overflow. Now researchers at the Stanford University School of Medicine have devised a computer algorithm that enabled them to swiftly sift through millions of reports to the U.S. Food and Drug Administration by patients and their physicians and identify "true" drug side effects. The method also worked to identify previously unsuspected interactions between pairs of drugs, … Continue reading →

An algorithm designed by US scientists to trawl through a plethora of drug interactions has yielded thousands of previously unknown side effects caused by taking drugs in combination. The work, published today in Science Translational Medicine1, provides a way to sort through the hundreds of thousands of 'adverse events' reported to the US Food and Drug Administration (FDA) each year. Its a step in the direction of a complete catalogue of drugdrug interactions, says the study's lead author, Russ Altman, a bioengineer at Stanford University in California. A program predicts the potential side-effects of mixing different pills. DWImages/Alamy Although clinical trials are often designed to assess the safety of a drug in addition to how well it works, the size of the trials needed to detect the full range of drug interactions would surpass even the large, late-stage clinical trials sometimes required for drug approval. Furthermore, clinical trials are often done in controlled settings, using carefully defined criteria to determine which patients are eligible for enrolment including other conditions they might have and which medicines they can take alongside the trial drug. Once a drug hits the market, however, things can get messy as unknown side-effects pop up. And thats … Continue reading →

ScienceDaily (Mar. 14, 2012) A week ago, you started a new prescription medication for acne. Today, you feel dizzy and short of breath and have difficulty concentrating. Your symptoms are not listed in the package insert as possible side effects of the drug, but why else would you be feeling so odd? Unfortunately, there's no easy answer. Clinical trials are designed to show that a drug is safe and effective. But even the largest trials can't identify irksome or even dangerous side effects experienced by only a tiny proportion of those people taking the drug. They also aren't designed to study how drugs interact with one another in the human body -- a consideration that becomes increasingly important as people age and their medicine cabinets begin to overflow. Now researchers at the Stanford University School of Medicine have devised a computer algorithm that enabled them to swiftly sift through millions of reports to the U.S. Food and Drug Administration by patients and their physicians and identify "true" drug side effects. The method also worked to identify previously unsuspected interactions between pairs of drugs, most notably that antidepressants called SSRIs interact with a common blood pressure medication to significantly increase the … Continue reading →