Many migraine patients have been prescribed promethazine to help during their migraine attacks, but those who have recently received bottles of this drug need to check them to be sure they aren’t involved in a voluntary recall triggered by the discovery that the drug atenolol was incorrectly bottled as promethazine.
The FDA reports that the Indian manufacturer involved in the recall is Cadila Healthcared, Ltd. The American distributor named is Zydus Pharmaceuticals USA Inc. The lot number is MN9081 with an expiration date of 9/2015.
Prescription bottles are required to contain identifying information in case of recall, so patients are encouraged to be sure and rule out the potential that they may have received some of the recalled medication. If you are unable to read the identifying information on your prescription bottle, please contact your pharmacist who is also required to maintain records of this information when a prescription is dispensed.
If you receive compounded promethazine, this does not mean that you are exempt from the potential you have received the recalled medicine, as some compounders occasionally use tablets to create another compounded form of the same drug. Please check these prescriptions as well and be sure you are safe.
Unfortunately, although pharmacists should be contacting affected customers, this may not happen. My personal experience is that I have never been contacted by any pharmacist at any time re: recalled medicine I have received. My experience may not be the norm, but hopefully it will encourage patients to perform due diligence and make sure for themselves that their medications are not involved in recalls or shortages.
Promethazine, also known as Phenergan is known more for its antihistamine properties than its neuroleptic uses, however it is effective in both areas. It is strongly active as a sedative and sometimes used to help patients with insomnia, but has weak neuroleptic effects. It is an anti-cholinergic and may not be safe for those with movement disorders such as dystonia, and may cause dry mouth and/or eye and may be contraindicated in Sjogren’s Syndrome patients, cancer patients, or others who already have serious dryness issues. It is often used for motion sickness, as an anti-nauseant, and when benzodiazapenes such as diazepam or lorazepam may be contraindicated. Promethazine is a drug that is often used in addition to other migraine medicines because it can help (potentiate) the other medicine by making the other medicine work more effectively than it normally would work by itself.
Yes, staying vigilant about the minor details of your medicines is more difficult work for sick patients to try to remember to do when they’re not necessarily feeling well. Remember, you have potential helpers in friends and family members who can assist you in keeping an eye out for potential problems, so the weight is not all on your shoulders when you’re feeling your worst.
In the recent past, there has been an immense increase in problems with prescription medicine, usually the result of their origination outside US labs. Usually the FDA website has been the best place to go for the most up to date information, however, Teri and I have recently found that this has not always been the case. Because we want you to be informed as soon as possible, we try to keep an eye on the FDA website as well as pharmacist organization websites who are often much quicker in notifying readers of shortages.
FDA. “Enforcement Report Week of May 28, 2014.” US Food and Drug Administration. Updated: May 28, 2014
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