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Fda Metformin Recall

Fda: Montelukast Tablet Bottles Recalled

Fda: Montelukast Tablet Bottles Recalled

(HealthDay)Some bottles of montelukast (Singulair) tablets for asthma have been recalled by Camber Pharmaceuticals because they contain the wrong medication, the U.S. Food and Drug Administration says. Bottles labeled as containing 30 tablets of 10-milligram montelukast sodium tablets instead contain 90 tablets of losartan potassium tablets. There is a safety risk because taking losartan when not prescribed can cause renal dysfunction , elevated potassium levels, and low blood pressure . The risk can be especially high for pregnant woman because losartan could harm or kill the fetus, the FDA said Friday. The recalled bottles have the following lot numbers: MON17384, expiration date: 12/31/2019, and NDC: 31722-726-30. Patients who have the recalled bottles should contact their health care provider or pharmacist immediately, the FDA said. Label mix-up spurs recall of accord blood pressure meds (HealthDay)One lot of high blood pressure medication is being recalled after a labeling mix-up, Accord Healthcare Inc. has announced. Hyland's teething tablets recalled over levels of toxic herb Hyland's teething tablets are being recalled nationwide due to inconsistent levels of toxic belladonna, which U.S. regulators say makes them a serious health hazard to young children. Bristol-Myers recalls Coumadin blood thinner (AP) -- Bristol-Myers Squibb Co. says it is recalling one production lot of its blood thinner Coumadin after finding an oversize tablet. Pfizer recalls a type of children's liquid advil (HealthDay)One lot of 4-ounce bottles of Children's Advil Suspension Bubble Gum Flavored is being recalled because a packaging problem could lead to an overdose, Pfizer Consumer Healthcare says. First generic versions of singulair approved (HealthDay) -- The first generic versions of Continue reading >>

Actos

Actos

Actos (pioglitazone) is an oral Type 2 diabetes drug that lowers blood sugar by decreasing insulin resistance and reducing the amount of glucose made in the liver. This allows the body to better dispose of excess blood sugar. Typically, the dose starts at 15 or 30 mg and is taken once a day, but some people may require a stronger dose. Doctors can increase the strength of the medicine by 15 mg increments to a maximum of 45 mg daily. However, numerous studies and a review by the U.S. Food and Drug Administration (FDA) link higher dosages and prolonged use to an increased risk of bladder cancer and other serious conditions. Actos is not intended to treat Type 1 diabetes or diabetic ketoacidosis. The drug can be used alone or with other Type 2 diabetes medicines such as metformin. There are two additional types of Actos that combine pioglitazone and metformin: Actoplus Met and Actoplus Met XR (extended release). What Does Actos Treat? Actos is approved to treat Type 2 diabetes in adults by improving glycemic (defined as causing glucose – sugar – in the blood) control. The drug comes in a tablet form to be taken by mouth daily and should be used in combination with diet and exercise. People with Type 2 diabetes do not make or use insulin well. Insulin is a hormone produced by the pancreas that regulates the amount of glucose in the blood. It moves blood sugar into cells where it is stored for later use as energy. Type 2 diabetes results in higher than normal levels of glucose because glucose does not enter cells. The body is then unable to use the glucose for energy. Type 2 diabetes is a lifelong (chronic) disease that can develop at any age, including during childhood. However, it mostly occurs in middle-aged and older people. The condition often develops slowly over t Continue reading >>

Diabetes Drug Recalled

Diabetes Drug Recalled

Aurobindo Pharma Ltd. is recalling a single lot of metformin hydrochloride tablets, USP, 1000 mg, after a metformin BP 1000-mg tablet was found in a bottle. The recall was included in the February 28, 2018, US Food and Drug Administration (FDA) Enforcement Report. The recall affects 500-count bottles from lot MTSC17145-A, which has an expiration date of July 2021. Bottles from the lot were distributed across the United States. Aurobindo Pharma voluntarily initiated the recall February 2, 2018. On February 16, 2018, the FDA designated it Class III, suggesting use of the affected product is not likely to cause harm. Metformin is a prescription drug used to improve glycemic control in people with type 2 diabetes. For more Pharmacy Learning Network articles, visit the homepage To learn about Pharmacy Learning Network Live meetings, click here NEW YORK (Reuters Health) - Patients recovering from sepsis may face a significantly increased risk of heart attack or stroke in the first four weeks after discharge from the hospital, researchers in Taiwan say. "The outcome of sepsis has been greatly improved in the past decade after the implementation of evidence-based sepsis care bundles," Dr. Chein-Chang Lee from National Taiwan University told Reuters Health by email. "The integration of stroke and myocardial prevention after sepsis recovery into the sepsis care bundle may have the potential to further improve the outcome." Dr. Lee and colleagues studied more than one million patients in a national Taiwanese database from 2000-2010, including 42,316 who had sepsis. Patients were matched to a general population control group with similar characteristics and to a hospital control group of patients who did not develop sepsis. As reported online September 10 in CMAJ, within 180 days Continue reading >>

Metformin (fortamet, Glucophage, Glumetza, Riomet)

Metformin (fortamet, Glucophage, Glumetza, Riomet)

Search results below include Worst Pills, Best Pills Newsletter Articles where your selected drug is a primary subject of discussion News Brief for October 2017 [hide all summaries] (October 2017) In this month’s news brief, we report on the FDA’s recent decision to partially grant a petition from Public Citizen to require the addition of a warning about a dangerous drug-drug interaction to product labeling of repaglinide-containing diabetes medications. Drugs That Are Most Likely to Land Patients in the Emergency Room [hide all summaries] (June 2017) Many adverse drug reactions are severe enough to cause serious injury, hospitalization and even death. Find out which outpatient medications are most likely to cause adverse events that necessitate a visit to the emergency room. Type 2 Diabetes: A Guide to Prevention and Treatment [hide all summaries] (May 2014) The treatment options for Type 2 diabetes can be overwhelming. This article provides a comprehensive summary of our independent expert views on the best approaches for preventing and treating this common disease. Exenatide (BYDUREON) Injection to Control Blood Sugar in Type 2 Diabetes [hide all summaries] (May 2012) The article explains why you should not use the newly approved diabetes drug exenatide (BYDUREON), a long-acting dosage form of the previously approved BYETTA. Important safety concerns cited in the drug’s label and FDA warnings are also discussed. Bladder Cancer Warning for Pioglitazone (ACTOS) [hide all summaries] (November 2011) Find out the full list of serious problems with pioglitazone (ACTOS) that cause it to be a DO NOT USE drug, of which bladder cancer is but the latest. Review of Type-2 Diabetes Medication Liraglutide (VICTOZA) [hide all summaries] (April 2011) This article reviews the s Continue reading >>

Janumet Side Effects Center

Janumet Side Effects Center

Janumet (sitagliptin/metformin HCl) is a combination of oral diabetes medicines for people with type 2 diabetes who do not use daily insulin injections. Janumet is not for treating type 1 diabetes. Common side effects of Janumet include: nausea, vomiting, stomach upset, diarrhea, constipation, headache, weakness, back pain, joint or muscle pain, a metallic taste in the mouth, or cold symptoms such as runny or stuffy nose, sneezing, and sore throat. Janumet does not usually cause low blood sugar (hypoglycemia). Low blood sugar may occur if Janumet is prescribed with other anti-diabetic medications. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Dosage of Janumet is individualized. Janumet is given twice daily with meals in 50 mg sitagliptin/500 mg metformin hydrochloride or 50 mg sitagliptin/1000 mg metformin hydrochloride doses. Hyperglycemia (high blood sugar) may result if you take Janumet with drugs that raise blood sugar, such as: isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills and other hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies. Hypoglycemia (low blood sugar) may result if you take Janumet with drugs that lower blood sugar, such as: nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid. It may also interact with amiloride, triamterene, cimetidine, ranitidine, digoxin, furosemide, morphine, nifedipine, procainamide, quinidine, trimethoprim, or vancomycin. Tell your doctor all medications you use. During pregnancy, Janumet should be used only when prescribed. Your doctor may Continue reading >>

Drug Recalls

Drug Recalls

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. See Definitions of Market Withdrawals and Class I, II, and III recalls .All recalls (Class I, II, and III) canbe found in the FDA Enforcement Report . In July 2011, FDA began a pilot programto notify people of drug recalls before they are classified. Theseunclassified recalls will be published in the Enforcement Report every Wednesday,and will be listed under the heading, Human Drug Product Recalls Pending Classification . They will be reposted with their classification once that determination has been made. Send comments or suggestions to [email protected] . If you have a medicinethat has been recalled, talk to your health care professional about the best course of action. Stores generally have a return and refund policy when a company has announced a recall of its products. NOTE: The recalls on the list aregenerally Class I.,which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. For recall notices older than 60 days, see the Recall and Safety Alerts Archive. Continue reading >>

Fda Announcement Leads Sun Pharma To Recall 2,500 Bottles Of Diabetes Drugs

Fda Announcement Leads Sun Pharma To Recall 2,500 Bottles Of Diabetes Drugs

Last Updated: Mon, Jul 30, 2018 20:17 hrs Sun Pharmaceuticals will be recalling 2508 bottles of metformin hydrochloride from Arizona, United States. This, owing to presence of foreign substance in one lot. The PTI reported Sun Pharma's US arm was asked to recall an entire batch with each bottle containing 500 tablets of 500 mg metformin hydrochloride. Metformin hydrochloride extended release tablets are used to improve glycemic control in adults with type 2 diabetes. The FDA is learnt of the presence of a rubber glove in one tablet, which was manufactured at Sun's Halol facility. The US FDA in its drug report categorized the voluntary recall as a class II act. According to the regulator, a class II recall is initiated in a situation "in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." The Sun Pharma stock was trading 1.12% up or by 6.25 points at Rs 563.20 a share on the Bombay Stock Exchange. The upwards trend is majorly attributed to the quarterly filings of Sun Pharma. Continue reading >>

Side Effects Of Metformin: What You Should Know

Side Effects Of Metformin: What You Should Know

Metformin is a prescription drug used to treat type 2 diabetes. It belongs to a class of medications called biguanides. People with type 2 diabetes have blood sugar (glucose) levels that rise higher than normal. Metformin doesn’t cure diabetes. Instead, it helps lower your blood sugar levels to a safe range. Metformin needs to be taken long-term. This may make you wonder what side effects it can cause. Metformin can cause mild and serious side effects, which are the same in men and women. Here’s what you need to know about these side effects and when you should call your doctor. Find out: Can metformin be used to treat type 1 diabetes? » Metformin causes some common side effects. These can occur when you first start taking metformin, but usually go away over time. Tell your doctor if any of these symptoms are severe or cause a problem for you. The more common side effects of metformin include: heartburn stomach pain nausea or vomiting bloating gas diarrhea constipation weight loss headache unpleasant metallic taste in mouth Lactic acidosis The most serious side effect metformin can cause is lactic acidosis. In fact, metformin has a boxed warning about this risk. A boxed warning is the most severe warning from the Food and Drug Administration (FDA). Lactic acidosis is a rare but serious problem that can occur due to a buildup of metformin in your body. It’s a medical emergency that must be treated right away in the hospital. See Precautions for factors that raise your risk of lactic acidosis. Call your doctor right away if you have any of the following symptoms of lactic acidosis. If you have trouble breathing, call 911 right away or go to the nearest emergency room. extreme tiredness weakness decreased appetite nausea vomiting trouble breathing dizziness lighthea Continue reading >>

Metformin Is Safe For Over 1 Million More People With Type 2 Diabetes

Metformin Is Safe For Over 1 Million More People With Type 2 Diabetes

FDA expands use to people with mild to moderate kidney disease. The FDA recently released a Drug Safety Communication announcing revisions to metformin’s label to expand use in people with type 2 diabetes and mild to moderate kidney (renal) impairment. Previously, the FDA advised against using metformin (Glucophage, Glumetza, Riomet, and Fortamet) in this group. The news could bring metformin to as many as 1.6 million more people with diabetes – a major win for the most widely prescribed diabetes drug. Metformin – a safe, cheap, and effective first-line drug in type 2 diabetes – was approved back in 1994. At the time, the FDA had concerns that metformin (which is cleared from the body through the kidneys) would accumulate in the bloodstream of people with reduced kidney function and put them at risk for lactic acidosis – a serious life-threatening condition if left untreated. As a result, the FDA prohibited metformin use for people with moderate to mild kidney disease. Physicians could still prescribe the drug “off-label,” though the safety warning certainly prevented many from accessing the drug. A study published in JAMA at the end of 2014 has helped change the FDA’s perspective. The authors reviewed 65 articles on metformin use in patients with kidney impairment, concluding that the FDA restriction was overly cautious and lacked adequate evidence to support it. The researchers found that even for people at the most extreme cut-off of moderate kidney impairment (an eGFR of 30 ml/min/1.73m2), metformin use did not lead to an increased risk for lactic acidosis. [Kidney function is assessed by a blood test called ‘eGFR,’ which estimates how much blood passes through the kidneys’ filter system each minute. It’s measured in the slightly clunky units Continue reading >>

Diabetes Drug Gets Fda Warning Due To Amputation Risk

Diabetes Drug Gets Fda Warning Due To Amputation Risk

HealthDay Reporter WEDNESDAY, May 17, 2017 (HealthDay News) -- The type 2 diabetes prescription drug canagliflozin (brand names Invokana, Invokamet, Invokamet XR) appears to increase the risk of leg and foot amputations, the U.S. Food and Drug Administration says. The FDA is requiring the medications to carry new warnings about the risk. The required warnings on the drug's labeling include the most serious and prominent boxed warning. The agency's decision is based on data from two large clinical trials showing that leg and foot amputations occurred about twice as often in patients taking canagliflozin as among those taking a placebo. Amputations of the toe and middle of the foot were the most common, but leg amputations below and above the knee also occurred. Some patients had more than one amputation, some had amputations involving both limbs, according to the FDA. Type 2 diabetes occurs when the body becomes resistant to insulin. Insulin is a hormone that helps to usher sugar from foods into the body's cells. When this process doesn't work correctly, blood sugar levels rise. Left untreated, high blood sugar levels can cause a number of possible complications, including heart disease, kidney problems and amputations, according to the American Diabetes Association. Canagliflozin is meant to be used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. These drugs lower blood sugar levels by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. Patients taking canagliflozin shoul Continue reading >>

Fda Warns About Rare Occurrences Of A Serious Infection Of The Genital Area With Sglt2 Inhibitors For Diabetes

Fda Warns About Rare Occurrences Of A Serious Infection Of The Genital Area With Sglt2 Inhibitors For Diabetes

FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes [8-29-2018] The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fourniers gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide . SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin (see FDA-Approved SGLT2 Inhibitors). In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away. Health care professionals should assess patients for Fourniers gangrene if they present with the symptoms described above. If suspected, start Continue reading >>

Fda Drug Safety Communication: Fda Revises Warnings Regarding Use Of The Diabetes Medicine Metformin In Certain Patients With Reduced Kidney Function

Fda Drug Safety Communication: Fda Revises Warnings Regarding Use Of The Diabetes Medicine Metformin In Certain Patients With Reduced Kidney Function

[ 4-8-2016 ] The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. We were asked1,2 to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function,3-14 and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin. We have concluded our review, and are requiring changes to the labeling of all metformin-containing medicines to reflect this new information. Health care professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Patients should talk to their health care professionals if they have any questions or concerns about taking metformin. Metformin-containing medicines are available by prescription only and are used along with diet and exercise to lower blood sugar levels in patients with type 2 diabetes. When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease. Metformin-containing medicines are available as single-ingredient products and also in combination with other drugs used to treat diabetes (see FDA Approved metformin-containing Medicines). The current drug labeling strongly recommends against metformin use in some patients whose kidneys do not work normally because use of metformin in these patients can increase the risk of developing a serious and potentially dead Continue reading >>

Dailymed - Glucophage- Metformin Hydrochloride Tablet, Film Coated Glucophage Xr- Metformin Hydrochloride Tablet, Extended Release

Dailymed - Glucophage- Metformin Hydrochloride Tablet, Film Coated Glucophage Xr- Metformin Hydrochloride Tablet, Extended Release

Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring (7) Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use (7) Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake (7) Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy. (8.3) Geriatric Use: Assess renal function more frequently. (8.5) Hepatic Impairment: Avoid use in patients with hepatic impairment. (8.7) See 17 for PATIENT COUNSELING INFORMATION. Advise the patient to read the FDA-approved patient labeling (Patient Information). Explain the risks of lactic acidosis, its symptoms, and conditions that predispose to its development. Advise patients to discontinue GLUCOPHAGE/GLUCOPHAGE XR immediately and to promptly notify their healthcare provider if unexplained hyperventilation, myalgias, malaise, unusual somnolence or other nonspecific symptoms occur. Counsel patients against excessive alcohol intake and inform patients about importance of regular testing of renal function while receiving GLUCOPHAGE/GLUCOPHAGE XR. Instruct patients to inform their doctor that they are taking GLUCOPHAGE/GLUCOPHAGE XR prior to any surgical or radiological procedure, as temporary discontinuation may be required [see Warnings and Precautions ( 5.1 )]. Inform patients that hypoglycemia may occur when GLUCOPHAGE/GLUCOPHAGE XR is coadministered with oral sulfonylureas and insulin. Explain to patients receiving concomitant therapy the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its Continue reading >>

Diabetes Medication Metformin: Why Patients Stop Taking It

Diabetes Medication Metformin: Why Patients Stop Taking It

Gretchen Becker, author of The First Year: Type 2 Diabetes: An Essential Guide for the Newly Diagnosed , has been taking metformin for more than 20 years after receiving a diagnosis of type 2 diabetes in 1996. I never had any problems with metformin until I took a pill that I thought was the extended-release version, but it wasnt, Becker told Healthline. Beckers doctor had accidentally prescribed the regular form of metformin. I had very loose bowels for several months until I figured out what the problem was, Becker said. After getting the proper prescription, it took several months for Beckers digestive system to recover. Corinna Cornejo, who received a diagnosis of type 2 diabetes in 2009, told Healthline that her digestive woes didnt start until shed been taking metformin for more than a year. At first, I thought it was a response to dairy, but my doctor eventually switched my prescription to the extended-release version, Cornejo recalled. That has helped, but the side effect has not gone away completely. For some people, however, metformins unpleasant side effect of loose stools provides a much-needed balance to the side effects that can result from other diabetes drugs theyre taking. GLP-1 drugs, like Victoza or Byetta, can cause constipation, explained Robinson. Taking metformin with a GLP-1 drug means they actually complement each other, balancing out those side effects. And for some, metformin simply isnt the right drug. No matter what you do, some patients just dont tolerate the side effects well, said Robinson. Although there are many diabetes drugs on the market today, doctors will likely push metformin first. There has never been as many diabetes treatment options available as there are now, explained Robinson. But doctors look at cost, and metformin is th Continue reading >>

Metformin Side Effects

Metformin Side Effects

shakiness dizziness or lightheadedness sweating nervousness or irritability sudden changes in behavior or mood headache numbness or tingling around the mouth weakness pale skin hunger clumsy or jerky movements If hypoglycemia is left untreated, severe symptoms may develop: confusion seizures loss of consciousness Call your doctor immediately if you have any of the following symptoms of hyperglycemia or high blood sugar: extreme thirst frequent urination extreme hunger weakness blurred vision If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms: dry mouth nausea and vomiting shortness of breath breath that smells fruity decreased consciousness Metformin may cause other side effects: diarrhea bloating stomach pain gas constipation unpleasant metallic taste in mouth heartburn headache sneezing cough runny nose flushing of the skin nail changes muscle pain Some side effects can be serious: chest pain rash Continue reading >>

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