Ketotifen Info Sheet
What Is It Really?
Ketotifen is very safe antihistamine (like Seldane or Benadryl) used extensively in Europe to treat bronchial asthma and allergies. It is also being studied as a treatment for colitis. The PWA Health Group is importing ketotifen because of preliminary reports that it lowers elevated levels of TNF-alpha, and can help PWAs gain weight.
The Theory Behind Ketotifen
German researchers have published data showing that ketotifen lowers tnf-alpha in the test tube. TNF-alpha is a naturally occuring protein that is often highly elevated in people with HIV and may be a primary part of HIV disease. It can turn on latent HIV, increasing the production of new virus; as well as cause generalized inflammation and AIDS related weight loss. But in addition to reducing TNF-alpha, ketotifen may help people gain weight in other ways. When used for asthma, weight gain and an increase in appetite were among the most frequent side effects. Ketotifen also protects the cells in the stomach, small intestine and perhaps the rest of the gut from a number of toxins. It is also being studied as a way to treat inflammatory bowel disease/colitis which has much in common with HIV-related gut problems. A number of case studies suggest that ketotifen may be helpful treating skin problems such as acne. Ketotifen also reduces edema (swelling and puffiness caused by water retention) around sores.
Ketotifen Studies in PWAs
Rather than focusing on ketotifen's TNF reduction as a means of slowing down HIV, the pragmatic Germans wondered what the drug might do for wasting. They published data from two small pilot studies in PWAs at last year's AIDS conference. One study used ketotifen in combination with oxymethadone, a steroid like Megace that helps people gain weight, so it is hard to gauge what effect ketotifen had (the study notes a 14% reduction in TNF-alpha levels and weight gains of 11-12 pounds in less than four weeks). A larger placebo controlled study of this combination is underway. The other study used ketotifen by itself in eight patients with elevated TNF-alpha, (but no wasting). Taking ketotifen for 12 weeks, these patients gained an average of six pounds, had increases in their body cell mass and reductions in their TNF-alpha levels.
Side Effects and Toxicity
Ketotifen is virtually non-toxic (although it is not advised for patients with epilepsy). People who took twenty times the recommended dose (in suicide attempts) suffered no serious consequences (other than embarrassment). Its primary side effects seem to be temporary drowsiness, dry mouth,(and other mucuos membranes) appetite stimulation and weight gain.
Ketotifen in Kids
Ketotifen is one of the rare drugs that has been extensively used and shown to be safe in children (above six months old). One study was in 107 children between six months and three years old with asthma. Children under 1 year were given .5 mg twice daily, the older children got 1 mg twice daily. Not only did the kid's asthma improve, they gained weight too.
No studies have been done to find the most effective dose for weight gain in PWAs. However, the German researchers are using 1 mg, four times a day for a total of 4 mg a day. However, much higher doses have been shown to be quite safe.
What We Carry
We import Zaditen brand ketotifen made by Sandoz Parmaceuticals in France. Each box contains 60 1 mg capsules. At the 4 mg a day dose, a box should last 15 days.
This article was provided by PWA Health Group.