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FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together

… Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial … system. As a result, we are requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)

… Copiktra was associated with a higher risk of serious side effects, including infections, diarrhea, inflammation of … or about possible alternative treatments. Read the patient Medication Guide every time you receive a prescription for … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes

… decreases in blood sugar and certain mental health side effects. The low blood sugar levels can result in … these updates in the drug labels and to the patient Medication Guides for the entire class of fluoroquinolones … Antimicrobial Drugs Information Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

… information already includes warnings about mental health side effects, including suicidal thoughts or actions; … allergy medicines. We are also requiring a new patient Medication Guide to educate patients and parents/caregivers … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA Drug Safety Communication: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings

… to conduct, 1 we have determined the risk of serious side effects on mood, behavior, or thinking with the … 2016 FDA  Advisory Committee meeting . The patient Medication Guide that explains the risks associated with the … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA Drug Safety Podcast: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

… combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce … expanded and revised to provide more detailed guidance on managing patients in buprenorphine treatment who are also …

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

… combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce … expanded and revised to provide more detailed guidance on managing patients in buprenorphine treatment who are also …

FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects

… certain uncomplicated infections; warns about disabling side effects that can occur together issued on May 12, 2016 … other parts of the drug label, including the patient Medication Guide. We have determined that fluoroquinolones … labeling changes for fluoroquinolones Think It Through: Managing the Benefits and Risks of Medicines Advisory …

Think It Through: Managing the Benefits and Risks of Medicines

… For many people, taking medication is a regular part of their daily routine, and … when you make decisions about the medicines you use. Managing Risk When a medicine's benefits outweigh its known … what they are supposed to do and when to expect results side effects and interactions whether you need any tests or …

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who are physically dependent on opioids

… and their healthcare providers know how to discontinue the medication safely. Proper discontinuation of opioids is … safe way to taper opioids that can avoid severe side effects and minimize risks. Critically important, any … clinician and ensuring follow-up and support for patients managing pain and changes to their medication regimens. There …

FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning

… FDA has issued new information about the combined use of medication-assisted treatment (MAT) drugs with … the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines … Center for …

FDA Drug Safety Communication: FDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)

… not result in significantly more serious asthma-related side effects than treatment with ICS alone. In 2011, we … * Randomized patients who took at least one dose of study medication. † Patients could have more than one event. … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines … Center for …

FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

… is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being … The Idhifa prescribing information and patient Medication Guide already contain a warning about … (PDF - 67KB) Related Information Think It Through: Managing the Benefits and Risks of Medicines The FDA's Drug …

Insulin Pumps: Tips for Using Your Insulin Pump at Home

… Before using your insulin pump Using your insulin pump Managing the most common problems with an insulin pump … Confirm that you are using the correct prescription medication. The drug container label should match your … what to look out for in terms of potential medication side effects and allergic reactions.  Provide you with …

FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function

… Health care professionals and patients should report side effects involving metformin or other medicines to the … if you have severe kidney problems. Read the patient Medication Guide or Patient Package Insert you receive with … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines … Center for …

FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder

… stomach-area or abdomen pain, or pain in the upper right side of your stomach-area or abdomen that may move to your … questions or concerns about the medicine. Read the patient Medication Guide that comes with each new Viberzi … than three alcoholic beverages a day Counsel patients on managing stress and making changes in diet and lifestyle to …

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

… we are also including new prescribing information on other side effects including central sleep apnea and drug … then once stable, proceed with a more gradual taper. When managing patients taking opioid analgesics, particularly … Treatment should include evidence-based approaches such as medication assisted treatment of opioid use disorder. Complex …

Helping Our Cats Live Healthier Lives—Information about FDA-Approved Drugs for Cats

… prescription. On this page: Mirataz and Elura for Managing Undesired Weight Loss in Cats Semintra for … at managing or, hopefully, curing the underlying disease, medication may be needed to try to stop or slow down the … than normal and become hyperactive. Vomiting is also a side effect in some cats receiving Mirataz, likely due to …

FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)

… We are also adding this updated information to the patient Medication Guide and the Prolia Risk Evaluation and … (FAERS) database . What is my risk? All medicines have side effects even when used correctly as prescribed. It is … evidence of CKD-MBD, and check blood calcium levels. Managing CKD-MBD, correcting hypocalcemia, and supplementing …

FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C

… also be included in the patient information leaflet or  Medication Guides for these medicines. Direct-acting … We urge health care professionals and patients to report side effects involving DAAs and other medicines to the FDA … follow-up. Consult a physician with expertise in managing hepatitis B regarding the monitoring and …

FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)

… Warning , our most prominent warning, and a new patient Medication Guide . We are also limiting the approved use of … who are not treated effectively or experience severe side effects with allopurinol. Uloric was FDA-approved in … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)

… information in the drug label and to the patient Medication Guide . We have also added the risk of stroke to … face, arms, or legs, especially if it occurs on only one side of the body Sudden confusion, trouble speaking, or … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Contact FDA For …

FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

… most effective ways to treat OUD. This approach, called medication-assisted treatment (MAT), is tailored to meet each … (FAERS) database. What is my risk? All medicines have side effects even when used correctly as prescribed, but in … Ensuring Drugs Are Safe and Effective    Think It Through: Managing the Benefits and Risks of Medicines Contact FDA For …

FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older

… We urge health care professionals and patients to report side effects involving opioid cough and cold medicines or … or falling into the wrong hands. Read the patient Medication Guide or patient information leaflet that comes … Ensuring Drugs Are Safe and Effective Think It Through: Managing the Benefits and Risks of Medicines Advisory …

FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients

… risk be added to the prescribing information and patient Medication Guide for all fluoroquinolones. Fluoroquinolone … fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection. … Ensuring Drugs Are Safe and Effective Think It Through:  Managing the Benefits and Risks of Medicines   … Center for …