One thing this site, (updates.pain-topics.org - see link below) does very well, is keep people up to date with the latest developments in drugs that pertain to their own illness. The world of Big Pharma and governmental health departments is constantly changing and things you take for granted regarding your medications can change very quickly.Aug 2012 – Pain Product Announcements; WarningsWednesday, August 1, 2012Featured Items: generic pregabalin approved; FDA REMS approval for long-acting and extended-release opioids; makers of unapproved oxycodone products warned to stop; defective All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.Generic Pregabalin – Several Firms Receive FDA Approval
Teva Pharmaceutical Industries, Lupin Ltd, and Watson Laboratories all received a July 2012 FDA approval of their application to produce pregabalin, the generic equivalent of Lyrica. The drug is indicated for neuropathic pain of diabetic peripheral neuropathy, post-herpetic neuralgia, and fibromyalgia, as well as adjunctive treatment for adults experiencing partial onset seizures. The capsules will be available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg strengths. For administration and safety information, see the pregabalin Medication Guide.REMS Approval for Long-Acting and Extended-Release Opioids After 3 years in development, the FDA has approved a shared Risk Evaluation and Mitigation Strategy (REMS) for the makers of all extended-release (ER) and long-acting (LA) opioid analgesics. The program is part of the FDA’s overall plan to reduce opioid prescription abuse while providing safe access to patients who need opioids to treat moderate to severe chronic pain. The educational component of the program includes prescriber training, patient counseling information, and a medication guide for each opioid product. Healthcare professionals will learn strategies for analyzing the risks and benefits in appropriate patients, as well as techniques for monitoring and counseling patients. Read the Pain-Topics UPDATE on the REMS approval for more information and links to useful resources.Unapproved Oxycodone Products – FDA Instructs Makers to Stop
Consistent with the FDA’s ‘Unapproved Drugs Initiative,’ the FDA issued a July 2012 Federal Register Notice advising companies that are manufacturing and distributing unapproved oxycodone products to stop these activities. This action is intended to protect consumers from immediate-release oxycodone drug tablets, capsules, and oral solutions that have not received FDA evaluation for safety and efficacy. The manufacturers were given 45 days to cease production and 90 days to discontinue shipment of existing drugs. See the FDA News Release for questions regarding this action and a list of National Drug Code (NDC) numbers for the unapproved single-ingredient oxycodone products.http://updates.pain-topics.org/2012/08/aug-2012-pain-product-announcements.html
Today's post from the very reliable drugs.com (see link below) talks about the dangers of getting neuropathy from taking Hivid (Zalcitabine) as part of your HIV medication combination. Fortunately Hivid is one of the older HIV drugs these days but is still widely taken across the world, especially in countries where budgets are tight and drug companies cynically sell their older products at reduced prices. The possibilities of suffering nerve damage are significant with Hivid (amongst other possible nasty side effects) so it may be worth your while discussing this with your HIV specialist and arguing the case that an alternative would be a better choice. Whether those alternatives are available is the question.
Dosage form: Tablets
Overview Side Effects Dosage Interactions For Professionals More...
This dosage information does not include all the information needed to use Hivid safely and effectively. See full prescribing information for Hivid.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
Patients should be advised that HIVID is recommended for use in combination with active antiretroviral therapy. Greater activity has been observed when new antiretroviral therapies are begun at the same time as HIVID. Concomitant therapy should be based on a patient's prior drug exposure. The recommended regimen is one 0.750 mg tablet of HIVID orally every 8 hours (2.25 mg HIVID total daily dose) in combination with other antiretroviral agents. Please refer to the complete product information for each of the other antiretroviral agents for the recommended doses of these agents. Based on preliminary data, the recommended HIVID dosage reduction for patients with impaired renal function is: creatinine clearance 10 to 40 mL/min: 0.750 mg of HIVID every 12 hours; creatinine clearance less than 10 mL/min: 0.750 mg of HIVID every 24 hours.
Monitoring of Patients
Complete blood counts and clinical chemistry tests should be performed prior to initiating HIVID therapy and at appropriate intervals thereafter. For comprehensive patient monitoring recommendations for other antiretroviral therapies, physicians should refer to the complete product information for these drugs. Serum amylase levels should be monitored in those individuals who have a history of elevated amylase, pancreatitis, ethanol abuse, who are on parenteral nutrition or who are otherwise at high risk of pancreatitis. Careful monitoring for signs or symptoms suggestive of peripheral neuropathy is recommended, particularly in individuals with a low CD4 cell count or who are at a greater risk of developing peripheral neuropathy while on therapy (see WARNINGS).
Dose Adjustment for HIVID
For toxicities that are likely to be associated with HIVID (eg, peripheral neuropathy, severe oral ulcers, pancreatitis, elevated liver function tests especially in patients with chronic Hepatitis B), HIVID should be interrupted or dose reduced. FOR SEVERE TOXICITIES OR THOSE PERSISTING AFTER DOSE REDUCTION, HIVID SHOULD BE INTERRUPTED. For recipients of combination therapy with HIVID and other antiretroviral agents, dose adjustments or interruption for each drug should be based on the known toxicity profile of the individual drugs. SEE INFORMATION FOR EACH DRUG USED IN COMBINATION FOR A DESCRIPTION OF KNOWN DRUG-ASSOCIATED ADVERSE REACTIONS.
Patients developing moderate discomfort with signs or symptoms of peripheral neuropathy should stop HIVID. HIVID-associated peripheral neuropathy may continue to worsen despite interruption of HIVID. HIVID should be reintroduced at 50% dose — 0.375 mg every 8 hours only if all findings related to peripheral neuropathy have improved to mild symptoms. HIVID should be permanently discontinued if patients experience severe discomfort related to peripheral neuropathy or moderate discomfort that progresses. If other moderate to severe clinical adverse reactions or laboratory abnormalities (such as increased liver function tests) occur, then HIVID and/or the other potential causative agent(s) should be interrupted until the adverse reaction abates. HIVID and/or the other potential causative agent(s) should then be carefully reintroduced at lower doses if appropriate. If adverse reactions recur at the reduced dose, therapy should be discontinued. The minimum effective dose of HIVID in combination with zidovudine for the treatment of adult patients with advanced HIV infection has not been established.
In patients with poor bone marrow reserve, particularly those patients with advanced symptomatic HIV disease, frequent monitoring of hematologic indices is recommended to detect serious anemia or granulocytopenia. Significant toxicities, such as anemia (hemoglobin of less than 7.5 gm/dL or reduction of more than 25% of baseline) and/or granulocytopenia (granulocyte count of less than 750 cells/mm3 or reduction of more than 50% from baseline), may require a treatment interruption of HIVID and zidovudine until evidence of marrow recovery is observed. For less severe anemia or granulocytopenia, a reduction in daily dose of zidovudine in those patients receiving combination therapy may be adequate. In patients who experience hematologic toxicity, reduction in hemoglobin may occur as early as 2 to 4 weeks after initiation of therapy, and granulocytopenia usually occurs after 6 to 8 weeks of therapy. In patients who develop significant anemia, dose modification does not necessarily eliminate the need for transfusion. If marrow recovery occurs following dose modification, gradual increases in dose may be appropriate depending on hematologic indices and patient tolerance. For more details, refer to the complete product information for zidovudine.
http://www.drugs.com/dosage/hivid.html
