FDA Sends Warning Notices to Ten Drug Companies for Lack of Safety Evidence
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On Apr. 27, 2012, the FDA sent warning notices to 10 drug companies manufacturing and distributing dietary supplements that contain dimethylamylamine, also known as DMAA. The FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.
Under law, manufacturers of dietary ingredients are responsible for notifying the FDA within 75 days of marketing their products with evidence that supplements containing new dietary ingredients are safe. "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that..." said Daniel Fabricant, PhD, Director of the FDA’s Dietary Supplement Program, in an FDA press release.
Last Updated (Wednesday, 02 May 2012 18:40)
Pradaxa Found to Cause Internal Bleeding
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Pradaxa (Dabigatran) is a blood-thinner medication used to prevent strokes or serious blood clots in people who have atrial fibrillation (a condition in which the heart beats irregularly). According to Boehringer, the maker of Pradaxa, this medication was found to cause internal bleeding in several hundred patients.
Other side effects of Pradaxa range from stomach pain, heart burn, nausea, headache, and joint pain to more serious side effects such as unusual bleeding or bruising, coughing up blood, vomiting bloody materials, bleeding from the gums, frequent nosebleeds, heavy menstrual bleeding, ulcers, and cerebral hemorrhaging.
Last Updated (Tuesday, 24 April 2012 10:16)
Revised Recommendations for Use of Celexa
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In August of 2011 the FDA announced that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at "doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart." Celexa is not recommended at any dose for patients with certain conditions because of the risk of QT prolongation. For other patients who require citalopram, the drug label has been modified to include the recommendations that:
- No greater than 40 mg/day of Citalopram should be taken. Larger doses cause too large an effect on the QT interval and confer no additional benefit.
- Patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure should not take citalopram.
- A maximum recommended dose of 20 mg per day should be taken by patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.
Propecia Label Change and Lawsuits
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The FDA recently announced a label change for the drug Propecia (commonly marketed as Proscar)- a drug designed to treat male-pattern hair loss and enlarged prostate glands - to include the warning risk of prostate cancer. Propecia, also known as the 5-alpha reductase inhibitor Finasteride, was found to increase the risk of developing high-grade prostate cancer (the most serious form of prostate cancer) after multiple clinical trials [including The Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE)].
Last Updated (Wednesday, 28 March 2012 11:04)
Sleep-Inducing Drugs Associated with Threefold Increased Risk of Death
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Hypnotic Drugs (drugs used to induce sleep such as Zolpidem and Temazepam) are among “the most widely used treatments in adult medicine”, according to a cohort study published by BMJ. In summary, the study concluded that these sleep-inducing drugs were associated with an increased risk of death, even for patients who were prescribed fewer than 18 doses per year.
According to BMJ, an estimated 6%-10% of American adults used some form of hypnotic drugs in 2010, and an even higher percentage may have used these drugs in parts of Europe. The study revealed that since 1979, sleep-inducing drugs have been found to increase mortality rates. Since then, 24 studies have examined the effects of hypnotic drugs- 18 of which found significant adverse effects.
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Drug Recalls - A Drug Safety Consumer Resource
Written by Drug Recall Writer
Anybody who watches television, surfs the Internet or flips through a magazine is very familiar with advertising for pharmaceutical drugs picturing attractive, healthy and active people. Prescription and over the counter drugs are used by millions of consumers for various ailments, diseases and medical conditions. For most, prescription drugs can provide great benefit or relief. A consequence of the development of many drugs and the marketing to millions of consumers, are serious side effects or other undesired results. In extreme cases, the U.S. Food & Drug Administration (FDA) or manufacturer may recall or withdraw a drug.
Over the past few years, the safety of more than a dozen popular prescription drugs has been examined. In some cases, certain drugs have been recalled following reports of serious injury or death.
The recent recall of numerous popular drugs has resulted in heightened scrutiny of certain blockbuster drugs with hearings before Congress in which at least one FDA researcher suggests that the FDA may be incapable of protecting consumers from unsafe drugs and that several other popular drugs currently on the market may also present unacceptable patient risk. According to a survey by the Department of Health & Human Services Office of Inspector General, about two-thirds of Food & Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
DrugRecalls.com is a consumer resource from product liability lawyers engaged in assisting consumers suffering side effects from pharmaceutical drugs.
Not all drugs referenced on this website have been subject to recall or warning. Patients should never stop taking their medicine without first consulting with their physician.
About Drug Recall Lawyer
Written by Drug Recall Lawyer
Lawyer of the Year Award...Through your outstanding leadership and advocacy, you have provided the voice of justice in protecting the basic human rights of your clients."
- California Governor, Gray Davis
"Legal Luminary" - The Wall Street Journal
Drug Recall lawyer Dana Taschner is one of the most respected trial lawyers in the United States. Dana has represented numerous individuals in pharmaceutical cases throughout the United States and founded Drug Recalls to provide helpful news and legal information about significant drug recalls impacting millions of consumers. Dana has provided expert legal analysis on CNN and MSNBC, and has been involved in some of the most significant and challenging legal cases in the United States over the last three decades: See Wall Street Journal article quoting Dana on nationwide consumer lawsuits on July 8, 2011 http://online.wsj.com/article/
"Great Plaintiff Lawyer" - The Huffington Post
Dana has been involved in many of the most significant and serious Food and Drug Administration (FDA) or manufacturer drug recalls in history, including: Silicone Gel Breast Implants (FDA ban in 1992), Norplant (birth control implant recall), Fen-Phen (diet drugs recalled in September 1997), Rezulin (diabetes drug recalled in March 2000), Sulzer (hip device recalled in 2000), Baycol (cholesterol drug recalled in August 2001), Zyprexa (schizophrenia drug warning of 2004), Ortho Evra (birth control patch recalled in 2004) Avandia (diabetes drug recalled in July 2007), Paxil (SSRI Black Box Warning 2004), and Depuy Recall (hip device recalled in August 2010). Dana represented thousands of consumers adversely affected by these products after serious side effects or deaths were reported in connection to these pharmaceuticals. Dana has filed the first legal claim in the Courts of the United States following FDA or manufacturer recall in certain national recall cases.
"The height of professional excellence…" - Highest national rating from lawyers and judges for skill and integrity.
For twenty consecutive years Dana has been awarded the highest national AV-rating (preeminent) for his legal ability and ethics based on reviews by judges and lawyers. Dana was awarded the American Bar Association's Sole Practitioner of the Year from a field of 400,000 lawyers, and the United States Senate honored Dana with a Senate Tribute, stating, "Taschner has achieved national recognition… Taschner truly brings honor to his profession." The Senate Majority Leader read into the Congressional Record, "Mr. Taschner's devotion to fighting oppression earned him the American Bar Association's Lawyer of the Year award."
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