FDA Approves Zoster Vaccine for Younger Adults

The US Food and Drug Administration (FDA) announced today approval for a vaccine to prevent herpes zoster, also known as shingles, in adults age 50 to 59 years. The vaccine, a live attenuated virus vaccine, was already approved for prevention of zoster in adults 60 years of age and older in May 2006.

Approval was based on a multicenter placebo-controlled trial conducted in the United States and 4 other countries among approximately 22,000 adults who were 50 to 59 years of age. Study participants were followed for at least 1 year for the development of zoster. Results showed that compared with placebo, the vaccine reduced the risk of developing zoster by approximately 70%. The most common side effects observed were redness, pain, and swelling at the site of injection and headache.

Abacavir - Safety Review:- Possible Increased Risk of Heart Attack

FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.

FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.

BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.

RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional.

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

Kaletra (lopinavir/ritonavir): Serious Health Problems in Premature Babies

FDA notified healthcare professionals of serious health problems that have been reported in premature babies receiving Kaletra (lopinavir/ritonavir) oral solution. Kaletra oral solution contains the ingredients alcohol and propylene glycol. Premature babies may be at increased risk for health problems because they have a decreased ability to eliminate propylene glycol; this could lead to adverse events such as serious heart, kidney, or breathing problems. Because the consequences of using Kaletra oral solution in babies immediately after birth can be severe or possibly fatal, the label is being revised to include a new warning.

BACKGROUND: Kaletra oral solution is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection in pediatric patients 14 days of age (whether premature or full term) or older and in adults.

RECOMMENDATION: The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity.

Recently banned drugs in INDIA

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Unapproved Cough, Cold, Allergy Products: DCGI Prompts Removal From Market

 DCGI announced that it intends to remove certain unapproved prescription cough, cold, and allergy drug products from the Indian market. Unapproved prescription cough, cold, and allergy drug products have not been evaluated by the DCGI for safety, effectiveness, and quality. People may be at greater risk when using these products than when using DCGI-approved prescription drugs or drugs that are appropriately marketed over-the-counter (OTC).

Many health care providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack DCGI approval.

BACKGROUND: Cough, cold, and allergy drug products are used to relieve symptoms associated with the common cold or upper respiratory allergies. These symptoms may include coughing, chest congestion, nasal congestion, itchy eyes, and sneezing. Some cough, cold, and allergy products may be purchased over the counter (OTC), while others require a prescription. See link below for a list of the unapproved prescription cough, cold, and allergy drug products DCGI intends to remove from the market.

RECOMMENDATION: Consumers who believe they are taking an unapproved prescription cough, cold, or allergy product should contact their health care provider to discuss alternatives.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the CliniLife Safety Information and Adverse Event Reporting Program.

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