Egypt Neuro Spine

Caution with Desmopressin (DDAVP, Minirin)FDA Alert: Desmopressin Acetate Linked to Seizures, Death in Children With Primary Nocturnal Enuresis (PNE). 

Desmopressin (INN, trade names DDAVP, Stimate, Minirin (Ferring Pharmaceuticals)) is a synthetic drug that mimics the action of antidiuretic hormone, also known as arginine vasopressin. It may be taken nasally, intravenously, or through a recently developed pill.

•     Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) may cause severe musculoskeletal pain  

 FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.[January 07, 2008 - Drug Information page - FDA]

  FDA Warns Viagra, Cialis and Levitra May Cause Sudden Hearing Loss or vision loss FDA SUMMARY [11/2007]:  FDA has received reports of cases of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, and Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension.  In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness.  Medical follow-up information was often limited for the cases reported postmarketing, which makes it difficult to determine whether these reports are directly related to the use of one of these drugs, an underlying medical condition, or other risk factors for hearing loss, a combination of these factors, or other factors. Sudden hearing loss was also reported in a few patients in clinical trials of these drugs.  In response to a request from FDA, the manufacturers of Viagra, Levitra and Cialis have revised the labeling for these products to address the potential risk of sudden hearing loss and to guide patients on what to do if they experience sudden problems with their hearing. FDA is currently working with the sponsor to revise the labeling for Revatio. The approved revised labeling for Viagra, Levitra and Cialis includes a new Precaution and updated Adverse Reactions sections.  The revised labeling is available at Drugs@FDA.

FDA ALERT [7/2005]: A small number of men have lost eyesight in one eye some time after taking Levitra, Viagra, or Cialis. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.
We do not know at this time if Levitra, Viagra, or Cialis cause NAION. NAION also happens in men who do not take these medicines. People who have a higher chance for NAION include those who: have heart disease, are over 50 years old, have diabetes, have high blood pressure, have high cholesterol, smoke, or have certain eye problems.

FDA has approved new labels for Levitra, Viagra, and Cialis to include information on possible eyesight loss (NAION).
Stop using Levitra, Viagra, or Cialis if you have a loss in your eyesight. Get medical help right away.

 

     Antiepileptic Drugs

For: Neuropsychiatric healthcare professionals, other healthcare professionals, patients
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.The drugs included in the analyses include (some of these drugs are also available in generic form):Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.[January 31, 2008 - Healthcare Professional Information Sheet - FDA]