Drug News

September 1 2010 - Tygacil (tigecycline): Label Change - Increased Mortality Risk  

ISSUE: FDA reminded healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections. FDA has updated sections of the Tygacil drug label to include information regarding increased mortality risk of Tygacil.

BACKGROUND: Tygacil is approved by FDA for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community acquired pneumonia. Tygacil is not approved for the treatment of hospital-acquired pneumonia (including ventilator-associated pneumonia) or diabetic foot infection. The increased risk was determined using a pooled analysis of clinical trials. See the Data Summary section of the FDA Drug Safety Communication for additional details.

RECOMMENDATION: Alternatives to Tygacil should be considered in patients with severe infections. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the Medwatch safety alert, including a link to the FDA Drug Safety Communication, at: MedWatch Safety Information

August 31 2010 - Aliskiren-amlodipine (Tekamlo by Novartis), has been approved by the FDA for the treatment of high blood pressure.  

August 26 2010 - atropine-pralidoxime (Duo-Dote by Meridian Medical Technologies), has been approved by the FDA for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.  Prescribing Information

August 26 2010 - Benzylpenicilloyl polylysine (PREPEN by ALK-Abello), has been approved by the FDA for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in patients suspected to have clinical penicillin hypersensitivity.  Prescribing Information

August 20 2010 - Stalevo (carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.

Background: Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own). It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.

Recommendations: At this time, FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional. FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete.

Read the complete MedWatch 2010 Safety summary, including links to the Drug Safety Communication with Data Summary and the previous related MedWatch alert from March 2010, at:  MedWatch Safety Information

August 16 2010 - Ulipristal (Ella by Watson Pharmaceuticals), has been approved by the FDA as new form of emergency contraceptive pill that prevents pregnancies if taken as many as five days after unprotected intercourse.   Prescribing Information

August 16 2010 - Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

ISSUE: FDA proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure         condition, orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done. To date, neither the original manufacturer nor any generic manufacturer has demonstrated the drug’s clinical benefit, for example, by showing that use of the drug improved a patient’s ability to perform life activities.

BACKGROUND: The drug, marketed as ProAmatine by Shire Development Inc. and as a generic by others, was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval required that the manufacturer verify clinical benefit to patients through post-approval studies.

RECOMMENDATION: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options. Read the MedWatch safety alert, including a link to the FDA Press Release, at:  MedWatch Safety Information

August 13 2010 - Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis

ISSUE: FDA notified healthcare professionals and patients that Lamictal (lamotrigine), a medication commonly used for seizures in children two years and older, and bipolar disorder in adults, can cause aseptic meningitis. Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light. In cases of meningitis, it is important to rapidly diagnose the underlying cause so that treatment can be promptly initiated.

BACKGROUND: The decision to revise the Lamictal label is based on FDA's identification of 40 cases of aseptic meningitis in patients taking Lamictal (from December 1994 to November 2009). See the Data Summary section of the Drug Safety Communication for additional information.

RECOMMENDATION: Patients should be advised to contact their healthcare professional immediately if they experience signs and symptoms of meningitis while taking Lamictal. If meningitis is suspected, patients should be evaluated for other causes of meningitis and treated as indicated. Discontinuation of Lamictal should be considered if no other clear cause of meningitis is identified.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: MedWatch Information

August 9 2010 - Alcaftadine ophthalmic (LASTACAFT by Vistakon) has been approved by the FDA for the prevention of itching associated with allergic conjunctivitis.  Prescribing Information

August 9 2010 - IncobotulinumtoxinA (Xeomin by Merz Pharmaceuticals) has been approved by the FDA for the treatment of adults with cervical dystonia or blepharospasm.  Prescribing Information

August 9 2010 - Chlorpheniramine-codeine Zodryl AC by codaDOSE Incorporated) is indicated for the temporary relief of cough, as may occur with the common cold or inhaled irritants, and for the temporary relief of runny nose, sneezing, itching of the nose or throat, and itchy watery eyes due to hay fever, other upper respiratory allergies, or allergic rhinitis. 

August 9 2010 - Nilotinib (Tasigna by Novartis) has been approved by the FDA for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.  Prescribing Information

August 9 2010 - Glycopyrrolate (CUVPOSA by Shionogi Inc) has been approved by the FDA for patients ages 3 -16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy.  Prescribing Information

August 2 2010 - Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms

ISSUE: FDA reminded healthcare professionals that oral nimodipine capsules should be given only by mouth or through a feeding or nasogastric tube and should never be given by intravenous administration. Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage (ruptured blood vessels in the brain) and is only available as a capsule. Intravenous injection of nimodipine can result in death, cardiac arrest, severe falls in blood pressure, and other heart-related complications.

BACKGROUND: In 2006, FDA added a Boxed Warning and made other revisions to the prescribing information to warn against intravenous use of nimodipine. The prescribing information also provides clear instructions on how to remove the liquid contents from the capsules for nasogastric tube administration in patients who are unable to swallow. The instructions recommend that the syringe used for withdrawal of capsule contents be labeled with "Not for IV Use." FDA continues to receive reports of intravenous nimodipine use, with serious, sometimes fatal, consequences.

RECOMMENDATION: The Drug Safety Communication, link below, provides additional information for Healthcare Professionals, for Patients, and a Data Summary of reported medication errors. FDA will continue working with the manufacturers of nimodipine and with outside groups to evaluate and implement additional ways to prevent medication errors with this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

·         Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summmary, including links to the Drug Safety Communication and current Prescribing Information, at: MedWatch Information

August 2 2010 - Amlodipine/hydrochlorothiazide/olmesartan (Tribenzor by Daiichi Sankyo), has been approved by the FDA to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics.  Prescribing Information

August 1 2010 - Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

ISSUE:  FDA notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to progressive respiratory failure and is potentially fatal if not quickly recognized and appropriately managed.

BACKGROUND: FDA has reviewed published case reports of Cubicin-associated eosinophilic pneumonia and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System. FDA's review identified 7 cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label.

RECOMMENDATION: Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing.

Additional information for Healthcare Professionals, Information for Patients, a Data Summary, and References are provided in the Drug Safety Communication.

Read the MedWatch safety alert, including links to the FDA Drug Safety Communication and Prescribing Information (drug label), at: MedWatch Information

August 1 2010 - Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

ISSUE: FDA notified healthcare professionals and patients that it is reviewing reports of adverse effects from Evamist, an estrogen hormone used to reduce hot flashes during menopause. Children unintentionally exposed to the drug through skin contact with women may  experience premature puberty. Female children may experience nipple swelling and breast development. Male children may experience breast enlargement.

BACKGROUND: Evamist is a topical product, sprayed on the skin on the inside of the forearm between the elbow and the wrist. FDA is currently reviewing reported adverse events and is working with the company to identify any factors that may contribute to unintended exposure. The Agency will update the public when this review is complete. FDA and the company are also evaluating ways to minimize the risk.

RECOMMENDATION: Patients should make sure that children are not exposed to Evamist and that children do not come into contact with any skin area where the drug was applied. Women who cannot avoid contact with children should wear a garment with long sleeves to cover the application site. Additional information for Healthcare Professionals, Information for Patients, and a Data Summary are provided in the Drug Safety Communication at the link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Online: www.fda.gov/MedWatch/report.htm
• Phone: 1-800-332-1088
• Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
• Fax: 1-800-FDA-0178

Read the MedWatch Safety Alert, including links to the Drug Safety Communication, FDA Consumer Update, FDA News Release, and Prescribing Information, at: MedWatch Information

August 2 2010 - Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure

ISSUE: FDA updated the Warnings and Precautions sections of the Prescribing Information for Afluria to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.

BACKGROUND:  FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are: Afluria, CSL Limited; Agriflu, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corporation; FluMist, MedImmune Vaccines Inc.; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.

The available data suggest that the increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSL’s vaccine. The available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere do not suggest an increased rate of fever or febrile seizure. FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children. The 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.

RECOMMENDATION: Vaccines for the 2010-2011 influenza season are approved by FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectable (“shot”) forms. Because the influenza viruses that cause people to get sick can change, each year's vaccine may be different from the previous year. Therefore, it is important to get the influenza vaccine every year.

Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. FDA is collaborating with Australia’s regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised and take part in the investigations. FDA, in collaboration with CDC, will closely monitor the continued safety of all influenza vaccines.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration.

Read the MedWatch safety alert, including links to FDA Q&As, News Release, Product Page, and the Package Insert, at:  MedWatch Information

July 15 2010 - Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

ISSUE: A recently published study - a meta-analysis combining cancer-related findings from several clinical trials - suggested use of ARBs may be associated with a small increased risk of cancer.

BACKGROUND: ARBs are used in patients with high blood pressure and other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

The meta-analysis included data from over 1,000 patients in several long-term, randomized, controlled clinical trials evaluating ARBs for which adverse events related to cancer were captured during the study. The mean duration of follow-up ranged from 1.7 to 4.8 years.

The study reported the frequencies of new cancer occurrence to be 7.2% for patients receiving ARBs compared to 6.0% for those not receiving ARBs (risk ratio = 1.08, 95% Confidence Interval: 1.01-1.15). No statistically significant difference in cancer deaths was noted.

RECOMMENDATION: FDA has not concluded that ARBs increase the risk of cancer. The Agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.

Read the MedWatch safety alert page, including a link to the Drug Safety Communication, at: MedWatch Information

July 15 2010 - Ondansetron (Zuplenz  by Strativa Pharmaceuticals), has been approved by the FDA oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication. 

July 13 2010 - Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

ISSUE: FDA is adding information on severe liver injury to the Boxed Warning of Arava (leflunomide) a drug used to treat rheumatoid arthritis - to highlight the risk of severe liver injury in patients using this drug and how this risk may be reduced. FDA previously required a Boxed Warning stating that leflunomide was contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception.

BACKGROUND: The decision to add information on severe liver injury to the Boxed Warning was based on FDA’s review of adverse event reports which identified 49 cases of severe liver injury, including 14 cases of fatal liver failure, between August 2002 and May 2009. In this review, the greatest risk for liver injury was seen in patients taking other drugs known to cause liver injury, and patients with pre-existing liver disease.

RECOMMENDATIONS: The information on severe liver injury being added to the Boxed Warning states:

• Patients with pre-existing liver disease should not receive leflunomide.
• Patients with elevated liver enzymes (ALT greater than two times the upper limit of normal) should not receive leflunomide.
• Caution should be used in patients who are taking other drugs that can cause liver injury.
• Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter.
• If the ALT rises to greater than two times the upper limit of normal while the patient is on leflunomide – leflunomide should be stopped, cholestryamine washout begun to speed the removal of leflunomide from the body and follow-up liver function tests conducted at least weekly until the ALT value is within normal range.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at: MedWatch Information

July 8 2010 - Buprenorphine (Butrans by Purdue Pharma), transdermal system has been approved by the FDA for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Prescribing Information.

July 8 2010 - Interferon alfacon-1 (INFERGEN by Three Rivers Pharmaceuticals, LLC), has received expanded labeling from the FDA to include daily use of (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. Prescribing Information

July 8 2010 - Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

ISSUE: Due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.

BACKGROUND: Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps.The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.

The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.

A data summary of adverse event reports received by FDA from April 2005 to October 2008 is provided in the Drug Safety Communication.

RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin. Patients are encouraged to read the Medication Guide given to them at the pharmacy before starting Qualaquin and each time they get a refill.  MedWatch Information

June 29 2010 - Formoterol-mometasone (DULERA by Merck) has been approved by the FDA for the treatment asthma for patients 12 years of age and older.  Prescribing Information. 

June 23 2010 - Ranibizumab (Lucentis by Genentech), has been approved by the FDA for the treatment of macular edema following retinal vein occlusion (RVO).  Prescribing Information

June 22 2010 - Cabazitaxel (Jevtana by Sanofi-Aventis), has been approved by the FDA for used in combination with prednisone to treat men with prostate cancer.  Prescribing Information

June 21 2010 - Mylotarg (gemtuzumab ozogamicin): Market Withdrawal

ISSUE: FDA notified healthcare professionals that results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

BACKGROUND: Mylotarg (gemtuzumab ozogamicin), indicated for treatment of acute myeloid leukemia (AML), a bone marrow cancer, was approved in May 2000 under the FDA’s accelerated approval program. A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

RECOMMENDATION: Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their healthcare professional. Healthcare professionals should inform all patients receiving Mylotarg of the product’s potential safety risks. Any future use of Mylotarg in the United States will require submission of an investigational new drug application to the FDA.  MedWatch Information

June 18 2010 - Nilotinib (Tasigna by Novartis), has been approved by the FDA for a new indication for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.  Prescribing Information

June 17 2010 - Dutasteride-tamsulosin (Jalyn by GlaxoSmithKline), has been approved by the FDA for the treatment of symptomatic benign prostatic hyperplasia in men with enlarged prostate.  Prescribing Information

June 15 2010 - Vitamin D Supplement Products: Medication Use Error

ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.

BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).

RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant. MedWatch Information

June 11 2010 - Benicar (olmesartan): Ongoing Safety Review

ISSUE: FDA is evaluating data from two clinical trials in which patients with type 2 diabetes taking the blood pressure medication, Benicar (olmesartan), an angiotensin II receptor blocker, had a higher rate of death from a cardiovascular cause compared to patients taking a placebo. FDA's review is ongoing and the Agency has not concluded that Benicar increases the risk of death. FDA currently believes that the benefits of Benicar in patients with high blood pressure continue to outweigh its potential risks.

BACKGROUND: The Agency plans to review the primary data from the two studies of concern, ROADMAP and ORIENT, and is considering additional ways to assess the cardiovascular effects of Benicar. ROADMAP and ORIENT are both long-term clinical trials. In both trials, patients with type 2 diabetes were given either Benicar or placebo to determine if treatment with Benicar would slow the progression of kidney disease. An unexpected finding observed in both trials was a greater number of deaths from a cardiovascular cause (heart attack, sudden death, or stroke) in the Benicar-treated patients compared to placebo.

RECOMMENDATION: Follow the recommendations in the drug label when prescribing Benicar. Additional Information for Patients, for Healthcare Professionals and a Data Summary are provided in the Drug Safety Communication below. Additional information about ROADMAP and ORIENT can be found at clinicaltrials.gov.  MedWatch Information

June 4 2010 - Racepinephrine (S2 Inhalant by Nephron Pharmaceuticals), has been approved by the FDA for temporary relief of shortness of breath, tightness of chest, and wheezing due to bronchial asthma. Prescribing Information

June 3 2010 - Denosumab (Prolia by Amgen), has been approved by the FDA for the treatment of postmenopausal women with osteoporosis at high risk for or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.  Prescribing Information

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