Category Archives: Drug Side Effects

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, theres no easy answer. Clinical trials are designed to show that a drug is safe and effective. But even the largest trials cant identify irksome or even dangerous side effects experienced by only a tiny proportion of those people taking the drug. They also arent 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 risk of a potentially deadly … Continue reading →

By Brian Orelli | More Articles March 13, 2012 | It looks like the anti-nerve growth factors might be able to re-emerge from the Food and Drug Administration clinical-hold graveyard. An FDA advisory panel recommended yesterday that the drugs are worth pursuing further despite the fact that osteoarthritis patients saw a higher rate of joint problems -- the very side effect that landed them on the FDA's naughty list. The big question: What the heck took so long? The FDA put the first clinical hold on Pfizer's (NYSE: PFE) tanezumab in June 2010 and halted the other anti-nerve growth factors being developed by Regeneron Pharmaceuticals (Nasdaq: REGN) , Sanofi (NYSE: SNY) , AstraZeneca (NYSE: AZN) , and Johnson & Johnson (NYSE: JNJ) by the end of that year. I'm all for keeping patients safe, but an earlier consult of the advisory panel sure would have been helpful for the companies and their investors -- it's not like the patent clock stops when drugs are put on clinical hold. The FDA doesn't have to follow the advice of the panel of outside experts, but with such an overwhelming majority saying the anti-NGF drugs are worth pursuing, I'd have a hard time … Continue reading →

Attorneys Andres Alonso and David Krangle announce that Alonso Krangle LLP is investigating birth defects allegedly associated with selective serotonin reuptake inhibitor antidepressants, SSRI, Side Effects, including Celexa, Lexapro, Paxil, Prozac, Zoloft and Effexor Melville, NY (PRWEB) March 13, 2012 Paxil Birth Defect Side Effects: In 2005, the U.S. Food & Drug Administration (FDA) moved Paxil from Pregnancy Category C to Category D because of its association with birth defects. The classification means that studies in pregnant women have shown a risk to the fetus. [fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051731.htm] Prozac Birth Defect Side Effects: In 1996, a study published in the New England Journal of Medicine revealed that women taking Prozac during pregnancy were two times as likely to deliver a baby with three or more minor abnormalities and poorer than average neonatal adaptation. [nejm.org/doi/full/10.1056/NEJM199610033351402] Zoloft Birth Defect Side Effects: A 2007 study in the New England Journal of Medicine reported that that babies born to women who used Zoloft during the first trimester of pregnancy were twice as likely to suffer heart-related birth defects. [http://www.nejm.org/doi/full/10.1056/NEJMoa067407 . Celexa: In 2010, Forest Laboratories paid out $313 million in damages under the False Claims Act for illegally marketing Celexa to children and for paying doctors … Continue reading →

Chemotherapy - a grueling treatment of cancer-busting chemicals - could become less toxic for patients based on new research into how cells shuttle the drugs inside. For chemotherapy to work, the chemical brew must enter cells through gatekeeper transporters and Sunday, researchers at Duke University revealed the structure of one transporter important in the shuttling of chemotherapy drugs into cells. The result could result in smarter design of chemotherapy drugs that enter into more cancerous cells and avoid healthy cells, the researchers said. "Knowing the structure and properties of the transporter molecule may be the key to changing the way that some chemotherapies, for example, could work in the body to prevent tumor growth," Seok-Yong Lee, assistant biochemistry professor at Duke University and senior author, said in a statement. The journal Nature published the study online Sunday. Chemotherapy treatments typically result in a host of side effects, including anemia, hair loss, fatigue and nausea, according to the National Cancer Institute. Like us on Facebook The research points to one approach doctors could use to reduce chemotherapy drug levels in patients and thereby reduce side effects. The focus of the study was a transporter that shuttles molecules made of nucleic acids … Continue reading →

London, Mar 12 (ANI): Scientists have determined the structure of a key molecule that can carry chemotherapy and anti-viral drugs into cells, which could help to create more effective drugs with fewer effects to healthy tissue. The transporter molecule, called a concentrative nucleoside transporter, works by moving nucleosides, the building blocks of DNA and RNA, from the outside to the inside of cells. "Knowing the structure and properties of the transporter molecule may be the key to changing the way that some chemotherapies, for example, could work in the body to prevent tumor growth," Seok-Yong Lee, senior author of the study from Duke University, said. The transporter molecule also transports nucleoside-like chemo drugs through cell membranes. Once inside the cells, the nucleoside-like drugs are modified into nucleotides that are incorporated into DNA in ways that prevent tumour cells from dividing and functioning. "We discovered the structure of the transporter molecule, and now we believe it is possible to improve nucleoside drugs to be better recognized by a particular form of the transporter molecule that resides in certain types of tissue. "Now we know the transporter molecule has three forms, which recognize different drugs and reside in different tissues," Lee said. … Continue reading →

While it can often work wonders against invading cancer cells, chemotherapy can also bring on very undesirable side effects, such as hair loss, nausea and vomiting. But the recent discovery of the structure of a certain molecule could potentially lead to the development of new drugs that could target tumors while avoiding damage to healthy tissue, resulting in possibly fewer side effects. The molecule, known as a transporter, can carry specific anticancer and antiviral drugs directly into cells. The drugs can then prevent tumor cells from dividing and multiplying. "If you really know what this transporter looks like, you can potentially design a cancer drug to be recognized by this transporter and carried into the cells, and you can lower the dose of cancer drugs and decrease the side effects as a result," said Seok-Yong Lee, an assistant professor of biochemistry at Duke University School of Medicine and lead author of the research, published online in the journal Nature. Experts not involved with Lee's research say development of such drugs is still a very long way off, but focusing on the ability of a drug to get into cancer cells makes scientific sense. "If it could be manipulated to help … Continue reading →

Public release date: 11-Mar-2012 [ | E-mail | Share ] Contact: Mary Jane Gore mary.gore@duke.edu 919-660-1309 Duke University Medical Center DURHAM, N.C. A team of researchers at Duke University has determined the structure of a key molecule that can carry chemotherapy and anti-viral drugs into cells, which could help to create more effective drugs with fewer effects to healthy tissue. "Knowing the structure and properties of the transporter molecule may be the key to changing the way that some chemotherapies, for example, could work in the body to prevent tumor growth," said senior author Seok-Yong Lee, Ph.D., assistant professor of biochemistry at Duke. The article was published in Nature online on March 11. The transporter molecule, called a concentrative nucleoside transporter, works by moving nucleosides, the building blocks of DNA and RNA, from the outside to the inside of cells. It also transports nucleoside-like chemo drugs through cell membranes. Once inside the cells, the nucleoside-like drugs are modified into nucleotides that are incorporated into DNA in ways that prevent tumor cells from dividing and functioning. "We discovered the structure of the transporter molecule, and now we believe it is possible to improve nucleoside drugs to be better recognized by a … Continue reading →

By Claire Bates UPDATED: 07:07 EST, 10 March 2012 A common heart disease drug may have the unusual side-effect of combating racism, a new study suggests. Volunteers given the beta-blocker, used to lower heart rates, scored lower on a standard psychological test of 'implicit' racist attitudes. They appeared to be less racially prejudiced at a subconscious level than another group treated with a 'dummy' placebo pill. Unusual finding: A heart drug was found to have the unusual side-effect of reducing racist feeling in participants Scientists believe the discovery can be explained by the fact that racism is fundamentally founded on fear. Propranolol acts both on nerve circuits that govern automatic functions such as heart rate, and the part of the brain involved in fear and emotional responses. The drug is also used to treat anxiety and panic. Experimental psychologist Dr Sylvia Terbeck, from Oxford University, who led the study published in the journal Psychopharmacology, said: 'We wanted to study the neurobiology of prejudice. 'Our results offer new evidence about the processes in the brain that shape implicit racial bias. 'Implicit racial bias can occur even in people with a sincere belief in equality. Given the key role that such implicit … Continue reading →

Posted by Shezad Malik MD JDMarch 10, 2012 5:19 PM The first three federal Pradaxa injury and death cases in the United States were recently filed. The first three landmark federal court Pradaxa lawsuits filed this week include: Lege et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-00572, in the U.S. District Court for the Western District of Louisiana; Bivens et al v. Boehringer Ingelheim Pharmaceuticals, Inc et al, Cause No. 3:12-cv-00103, in the U.S. District Court for the Eastern District of Tennessee, Northern Division; and Hawkins et al v. Boehringer Ingelheim Pharmaceuticals Inc et al, Cause No. 6:12-cv-45, in the U.S. District Court for the Eastern District of Kentucky, London Division. There is an ongoing U.S. Food and Drug Administration (FDA) investigation into Pradaxa and its potentially deadly side effects. The FDA is now investigating post-marketing reports of serious bleeding events and deaths in patients taking Pradaxa (dabigatran etexilate). Pradaxa History Pradaxa was approved in October 2010 by the FDA for the prevention of stroke in patients with non-valvular atrial fibrillation. Atrial fibrillation is the most common heart rhythm condition in the world. Patients with atrial fibrillation require blood-thinning medications like warfarin. Pradaxa was the first … Continue reading →

NEW YORK (AP) -- Pfizer Inc. said Friday it is ending a safety study of its pain drug Celebrex because of difficulty finding patients. The trial was designed to measure the effects of Celebrex on patients who were taking the drug to treat juvenile idiopathic arthritis. Pfizer said it was having trouble enrolling patients in the trial, and the study was not likely to produce meaningful results because patients with the condition tend to use Celebrex for a short time and because the rate of side effects was very low. Sales of Celebrex grew 6 percent to $2.52 billion in 2011, which made it Pfizer's fifth-best-selling drug. It was originally approved in 1998, and Pfizer was required to do the safety study in 2006 after Celebrex was approved as a treatment for juvenile idiopathic arthritis. The company said the Food and Drug Administration released it from its requirement. Shares of Pfizer rose 3 cents to end Friday's session at $21.48. The stock has traded between $16.63 and $22.17 in the past 52 weeks. See more here: Pfizer ends Celebrex post-approval safety study … Continue reading →