If there were concerns regarding Posicor's safety, why did the FDA grant approval?
Untitled PageDespite the fact that the FDA was aware of cases of heart arrhythmia and death associated with Posicor, it was unable to confirm these reports because Hoffman-LaRoche, Inc. did not make such reports public. Instead of delaying the approval for up to a year, the FDA approved the drug despite its concerns. According to the FDA, the drug does not offer any significant benefits that are not currently found in safer medications.
Related QuestionsWhat actions did FDA take regarding these reports?
Ketek Lawsuit Research - FDA Frequently Asked Questions (FAQ...The Office of Drug Safety looked at adverse events, including hepatic adverse events, in a consult in June 2005 and concluded that there was no new information that changes its assessment of the hepatic risks.
Related QuestionsWhat previous actions has FDA taken regarding safety concerns with ESAs?
Aranesp, Epogen & Procrit FAQ - Trial Lawyers, Nationwid...The product labels for all US marketed ESAs have been updated several times since the original approvals to incorporate new safety information. The FDA has closely monitored emerging safety information and requested post-marketing studies to address actual and potential safety concerns. These included requests for post-marketing studies to assess risks of blood clots and effects on cancer.
Related QuestionsAre there any safety concerns regarding concrete?
Ready Mixed Concrete Co. - FAQFresh (wet) concrete is highly alkaline and can cause skin irritation, severe third degree chemical burns and serious eye damage. Always wear protective gloves and glasses or goggles when working with wet concrete. Waterproof boots must also be worn if standing or walking in wet concrete. If clothing becomes contaminated with wet concrete, it should be removed at once and the affected body area(s) washed immediately. Flush eyes with clean water immediately after contact.
Related QuestionsAre there any safety concerns regarding TcMEPs?
FAQs: Learn More about Biotronic and the Services We OfferThousands of patients have been monitored safely using TcMEPs with very few complications. The primary safety concerns revolve around the stimulation of the patient???s cranium. Stimulation can cause significant movement of the patient???s head and neck muscles. Direct activation of the temporalis muscle and/or activation of the trigeminal nerve will cause a brief clenching of the jaw.
Related QuestionsDid the product labeling of Posicor label discuss any drug interactions?
Untitled PageYes, the product labeling warned patients not to use Posicor if they were currently using taking certain allergy pills, tranquillizers, sleeping pills, or the drug Propulsid.
Related QuestionsHow much money did Posicor's manufacturer hope to make off the drug?
Untitled PageAccording securities analysts, Posicor was expected to generate over $3 billion for Hoffman-LaRoche, Inc.
Related QuestionsWhen did ReSTOR receive FDA approval?
ReSTOR/ReZoom Multifocal Lens Procedure - Cataracts, Presbyo...The AcrySof ReSTOR received FDA-approval for cataracts with or without presbyopia on March 23, 2005. It has been approved for use in Europe since April 4, 2003.
Related QuestionsWhat about FDA Approval?
NBC, Nuclear, Biological and Chemical Preparedness, Info Pag...IOSAT Potassium Iodide is the only full strength brand tested and approved by the FDA for radiation emergencies. ThyroShield is the only liquid Potassium Iodide approved by the FDA.
Related QuestionsWhat if the FDA does not give us the approval?
Frequently Asked Questions on thWe will seek legal action since it is a violation of your religious rights and the FDA does have the option by federal law to allow it. And of course we will continue to work toward full US licensing.
Related QuestionsAre there any special safety concerns I should be aware of?
Vesalius College - Study Abroad FAQ InboundYou should always use your best judgment when in a foreign country, just as you would at home. The following basic safety guidelines should be observed: When you travel, use a security pouch to carry your passport, credit cards and traveller’s checks. Never use, handle, or distribute controlled or illegal substances. The punishments in other countries can be very severe. Use the same precautions for HIV/AIDS/STDs and unwanted pregnancies overseas as you would at home.
Related QuestionsWhat did they decide about safety concerns?
SAFETY AND JUSTICE IN FUTURE CLINICAL RESEARCH WITH HUMAN EM...A: The panel reports their conclusions on safety in the November issue of Fertility and Sterility. First, there are many fundamental aspects of human ES cell lines that need to be understood before the cells could be used in people. Among the concerns identified by the panel include the risk the transplanted cells might form tumors, travel to the wrong place in the body, or become undesired cell types.
Related QuestionsDoes The FDA Monitor This Process And Do You Have Their Approval To Do This?
Umbilical Cord Blood Frequently Asked QuestionsTo date, the FDA does not regulate stem cell preservation. However, since our lab is a public Blood Center it must follow all FDA guidelines and regulations for the collection, testing and processing of blood and blood products. They monitor themselves and follow the same safety/sterile procedures in the stem cell preservation program that they do for all other programs. The tests performed on your sample are the same tests done on every unit of blood collected for the Blood Center.
Related QuestionsWhat safety concerns will my principal have?
Frequently Asked Questions about Field Trips, Sandy Hook, NJ...If you have special-needs students or special requests (waivers, etc.), these must be stated with your field trip request form. Please do not contact us after the trip is scheduled to make additional requests. One person - the teacher, principal or secretary - should be the sole contact for the group. Please have parents make special requests through that that person. This will avoid confusion on the day of your trip.
Related QuestionsAre there any health or safety concerns with the wireless signal?
Phoenix Internet Wireless Faq's - Wireless FAQsNo. The technology used by Phoenix Internet operates at very low power levels, similar to a cell phone, and much less than the amount that is emitted by your microwave oven. Also, radio frequency power drops dramatically as you move away from the power source. Typically, our antennas would not be placed where any person would be able to stand right in front of it for any significant period of time.
Related QuestionsAre there safety concerns?
Frequently Asked QuestionsOHSU plans to construct the two supporting towers in one of the areas in Portland most at risk for serious earthquakes. The consequences for those below a falling aerial tram tower, cables, or aerial tram car would be disasterous. Gibbs Street is the Life Flight helicopter path to OHSU, and there is no practical way to light the entire cable length for the aerial tram, which puts the cable at risk for a collision.
Related QuestionsCroatia Only Tours - Frequently Asked QuestionsCroatia, like most small European countries, is extremely safe. It can be favorable compared to small states in the United States for safety.Related Questions
buy BZP (Benzylpiperazine) Party pills online.Do not take these pills if you are pregnant or breast feeding, when on medication, or when suffering any mental or physical health condition without first seeking professional medical advice. Do not mix with other drugs, supplements, medicines or alcohol. Do not operate any vehicles or machinery while using any of these products.Related Questions
What are the concerns over new FDA guidelines?
Embryos aliveNEW YORK, Feb. 10 -- On May 25, 2005, new FDA guidelines for the donation of human cells, tissues, and cellular and tissue-based products (HCT/Ps), will go into effect. Reproductive tissue -- sperm, eggs and embryos -- falls under these testing guidelines. The potential impact for men and women seeking to build families through such donations will be significant.
Related QuestionsWhat conditions of approval did FDA place on these implants?
Breast Implants FAQ, Breast Augmentation FAQ, Silicone Breas...Continue its Core Study until all patients have completed their 10-year evaluation in order to assess the long-term clinical performance of its product.
Related QuestionsWhat is a post-approval study, and why did the FDA mandate that Mentor conduct it?
FAQs about MemoryGel - Silicone Gel Breast Implants by Mento...A post-approval study is a clinical study or other investigation included in the PMA approval order to gather specific information to address precise study objectives about an approved medical device. FDA has concluded that both Mentor and Allergan need to provide additional long-term safety data on gel-filled breast implants. Mentor???s post-market study is an effort to continue to evaluate the product over the long-term.
Related Questions_WHEN DID PROVENTIL HFA RECEIVE FDA APPROVAL?
FAQ's....quot;Yes, PROVENTIL HFA has a yellow plastic actuator and an orange cap. The Warrick CFC albuterol has a white plastic actuator with white cap." quot;No, use PROVENTIL HFA only with the mouthpiece supplied with the product. The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product canisters, and the actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister."
Related QuestionsDid the UN raise concerns regarding discrepancies in the Oil-for-Food Program?
Oil-for-Food: FactsYes, the UN’s OIP raised concerns about potential wrongdoing in the Oil-for-Food program on multiple occasions. On November 17, 2000, UN oil overseers informed the 661 Committee that formulas proposed for oil pricing for the month of December were considerably under-priced and did not appear to represent "fair market value.
Related QuestionsWhen and why was Posicor removed from the market and why?
Untitled PagePosicor was removed from the market in 1998 after it was determined that Posicor caused various heart conditions including arrhythmias and low blood pressure. Over 140 deaths have been attributed to Posicor use.
Related QuestionsKids and Cats: what are the safety concerns?
FAQ'sCats can usually be quite happy and comfortable around children. However, it does require work if you want to have a safe relationship between your children and your cat. First of all, cats will usually run away if they do not want to be bothered. If you can teach your child to not chase the cat this will be a big first step. If possible, provide a "safe-haven" for your cat to go to if it needs to get away. A baby-gate or elevated perch usually will do the trick.
Related QuestionsDo the other statins have the same safety concerns as Baycol?
Untitled PageAll statins have been associated with very rare reports of rhabdomyolysis. These rare cases can occur when the drugs are used alone or in combination with another lipid-lowering drug such as gemfibrozil. However, cases of fatal rhabdomyolysis in association with Baycol use have been reported more frequently than other approved statins. Your question will be referred to an attorney near you.
Related QuestionsWhat are the public health, safety, and environmental concerns associated with landfill gas?
Environmental Protection Agency - LMOP: Frequently Asked Que...The public health, safety, and environmental concerns fall into three categories: subsurface migration, surface emissions/air pollution, and odor nuisance. Subsurface migration is the underground movement of landfill gas from landfills to other areas within the landfill property or outside the landfill property. (Note: Most subsurface migration occurs at older, unlined landfills because there is minimal barrier for lateral migration.
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