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Showing posts with the label drugs alert

Lyrica male-mediated teratogenicity

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Lyrica male-mediated teratogenicity Pregabalin is an anticonvulsant and neuropathic pain agent. Exactly how pregabalin works is not known. It is thought to bind to certain areas of the brain that help reduce seizures, nerve pain, and anxiety. Treating fibromyalgia or nerve pain caused by certain conditions (eg, shingles, diabetic nerve problems, spinal cord injury). It is also used in combination with other medicines to treat certain types of seizures. Men being treated with pregabalin should be informed of the potential risk of male-mediated teratogenicity. Animal studies have reported increased incidences of: specific skull alterations attributed to abnormally advanced ossification,  retarded ossification,  increased incidences of skeletal malformations,  decreased fetal body weights,  visceral variations.  When offspring were tested as adults, neurobehavioral abnormalities and reproductive impairment were observed.

Serious and Life-Threatening Cases for use Harvoni and Sovaldi with amiodarone

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Serious and Life-Threatening Cases for use Harvoni and Sovaldi with amiodarone Serious and Life-Threatening Cases of Symptomatic Bradycardia, as well as One Case of Fatal Cardiac Arrest, Reported with Coadministration of amiodarone with either Harvoni® (ledipasvir and sofosbuvir fixed-dose combination) or with Sovaldi® (sofosbuvir) in combination with another direct-acting antiviral. The specific changes to each label are summarized below. Harvoni label changes: WARNINGS AND PRECAUTIONS Serious Symptomatic Bradycardia When Coadministered with Amiodarone Postmarketing cases of symptomatic bradycardia, including fatal cardiac arrest and cases requiring pacemaker intervention, have been reported when amiodarone is coadministered with HARVONI. Bradycardia has generally occurred within hours to days, but cases have been observed up to 2 weeks after initiating HCV treatment. Patients also taking beta blockers, or those with underlying cardiac comorbidities and/or advanced liver ...

A current list of medications that require refrigeration

Although not a complete list, below you’ll find a list of the most common medications that require refrigeration.     * • Actimmune® (interferon gamma 1B)     * • Benzamycin® (erythromycin/benzoyl peroxide)--gel     * • Benzaclin® (clindamycin/benzoyl peroxide)--gel     * • Betaseron® (interferon beta 1B)--vials

Plavix and PPIs bad company

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2010 and February 2011 WARNINGS and PRECAUTIONS Diminished Antiplatelet Activity Due to Impaired CYP2C19 Function

Reducing Fever in Children: Safe Use of Acetaminophen

You’re in the drug store, looking for a fever-reducing medicine for your children. They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest. This could be a dangerous mistake.

Crestor and Zocor Drugs Linked to Muscle Degeneration, Rhabdomyolysis

EDISON, N.J. , July 15, 2011 /PRNewswire/ -- Crestor and Zocor are widely-used prescription strength drugs designed to lower "bad cholesterol". Both drugs are classified as "statins", medicine which lowers blood cholesterol levels by inhibiting HMG-CoA reductase. This group of drugs has had a controversial history, starting with Baycol, a drug similar to Crestor and Zocor, touted as a "super statin" before its recall from the market.

Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL)

Labeling changes are being made to Tamiflu oral suspension to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.  The changes to the product label include:

U.S. Prescribing Information for Simvastatin Revised

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The changes follow a U.S. Food and Drug Administration (FDA) review, announced by the agency in March 2010, of the risk of muscle injury (called myopathy, including its most serious form, rhabdomyolysis) with the highest dose of simvastatin. Merck has updated the U.S. prescribing information:

Drugs for Enlarged Prostate May Raise Risk of Aggressive Cancer

 The U.S. Food and Drug Administration is calling for new warning labels on a class of drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

FDA alert Slim Xtreme Herbal Slimming Capsule

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All lots of Slim Xtreme Herbal Slimming Capsule, 30 Capsules/Bottle, are being recalled. The products were sold and distributed nationwide via the internet and at the company’s headquarters in Hollywood, Florida.

Use Caution When Prescribing Fluoroquinolones to Athletes

Adverse musculoskeletal side effects have been well documented with the use of fluoroquinolone antiobiotics. In 2008, the US Food and Drug Administration (FDA) placed a black box warning, as well as further medication recommendations, on all fluoroquinolones due to the increased risk of developing tendinitis and/or tendon rupture. A review of the current literature by Dr. Hall and colleagues discusses potential mechanisms of pathology, identifies risk factors, and proposes updated guidelines in the athletic population, which include:

FDA Warns About Teething Medication Main Ingredient Benzocaine Linked to Rare, Serious Disease

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May 5, 2011 -- The FDA has issued a warning to consumers about the use of benzocaine, the main ingredient in over-the-counter liquids and gels used to reduce teething pain in very young children. Benzocaine is associated with a rare but serious condition called methemoglobinemia, which greatly reduces the amount of oxygen carried through the bloodstream. In the most severe cases, the condition can be life-threatening.

Warfarin : Use May Raise Risk of Death From Traumatic Injuries

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MONDAY, Jan. 17 -- New research shows that the risk of dying after suffering a traumatic injury is much higher for people taking warfarin, the most commonly used blood thinner in America. The study found that of more than 1.23 million patients who went to emergency rooms with serious injuries, those taking warfarin (Coumadin) were almost twice as likely to die (9.3 percent vs. 4.8 percent).

FDA Lowers Amount of Acetaminophen Allowed in Prescription Painkillers

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THURSDAY, Jan. 13 -- U.S . health officials announced Thursday that they will lower the maximum amount of the pain reliever acetaminophen allowed in prescription opioid products such as Vicodin and Percocet because of reports of severe liver damage.

FDA ; Combating Misuse and Abuse of Prescription Drugs

  Q&A with Michael Klein, Ph.D. Pharmacologist Michael Klein, Ph.D., is director of the Food and Drug Administration (FDA) Controlled Substance Staff. During more than 30 years of federal service, he has amassed extensive experience with issues related to drug regulation, abuse, misuse, and addiction. Prior to joining FDA 20 years ago, Dr. Klein worked as a senior scientist with the Drug Enforcement Administration (DEA).

FDA ; Possible Increased Risk of Bone Fractures With Certain Antacid Drugs

There is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers, warns the Food and Drug Administration (FDA). The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter (OTC) medications.

FDA Alert : Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

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Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. 

FDA Alert : Slim- 30 Herb Supplement: Undeclared Drug Ingredient

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FDA lab analysis of Slim-30 Herb Supplement distributed by the company was found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved this product, therefore the safety and effectiveness of the product is unknown. This product poses a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

FDA alert : Que She Weight Loss Capsules Contain Potentially Harmful Ingredients

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The U.S. Food and Drug Administration today warned that Que She, marketed as an herbal weight loss supplement, contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions. People who have purchased Que She should stop taking the product immediately and consult a health care professional.