Check the Mesalazine Headache and Vision Warning in Pakistan: What DRAP Alert 61 Says
DRAP Alert 61 says mesalazine can very rarely raise pressure in the skull. See the signs to watch, why you should not stop alone and how to report a reaction.
Short answer: DRAP Safety Alert No. 61 of 30 January 2026 says mesalazine, a medicine for ulcerative colitis and Crohn's disease, has very rarely been linked to raised pressure inside the skull. If you take it and get headaches that keep getting worse, blurred vision or ringing in the ears, tell your doctor straight away.
Mesalazine is also sold as 5-ASA, and many Pakistani patients with bowel disease take it for years. The alert does not ask anyone to stop the medicine on their own. It asks patients and doctors to watch for a short list of warning signs.
We read the alert on DRAP's safety page on 13 October 2026. This article explains it in plain words.
DRAP warns that mesalazine can very rarely raise pressure in the skull
The alert says idiopathic intracranial hypertension, called IIH, has been very rarely reported in people taking mesalazine. IIH means pressure inside the head goes up without a clear cause. DRAP says it is not normally life-threatening, but in rare cases it can cause serious vision problems.
The alert follows reviews by drug regulators in the United Kingdom and Europe. The UK regulator had received 6 reports of raised pressure inside the skull linked to mesalazine when the alert was written, which DRAP describes as a very low number. The benefit and risk balance of the medicine did not change.
Know the signs that DRAP lists for patients
DRAP tells patients to inform their doctor immediately if they have headaches that become progressively more severe and keep returning, disturbed vision, ringing or buzzing in the ears, back pain, dizziness or neck pain. A single mild headache on one day is not the same thing.
| Sign | What the alert says |
|---|---|
| Headache that gets worse and returns | Tell your doctor immediately |
| Blurred or double vision | Tell your doctor immediately |
| Ringing or buzzing in the ears | Tell your doctor immediately |
| Back pain, neck pain or dizziness | Tell your doctor immediately |
Some of these signs also happen with many common illnesses. That is why the alert asks you to talk to your doctor and not to decide alone.
Do not stop mesalazine without asking your doctor
The alert tells doctors that stopping mesalazine should be considered if IIH occurs. It does not tell patients to stop. Stopping suddenly can bring back bowel symptoms, so the choice belongs to the doctor who treats your colitis.
- Write down your symptoms, the date each began and how often they come.
- Contact the doctor who prescribed mesalazine. Say clearly that you take it.
- Keep taking the dose until the doctor says otherwise.
- Ask about an eye check if your vision has changed.
- Report the reaction to DRAP afterwards.
What DRAP has ordered in Pakistan
Pakistan's expert committee reviewed the matter on 31 December 2025. It decided that every company holding a registration for mesalazine must add the IIH risk to the warnings section of the label. The risk is listed with the frequency "not known", meaning the data cannot give a figure.
The alert names no brand and no batch. It is not a recall. Your pack is not unsafe because of it. If you want to confirm that your brand is registered, use the DRAP registration check, and if a batch is ever withdrawn the page on checking a recalled batch shows where to look.
Questions to take to your next clinic visit
A short list helps a short appointment. Bring it on paper or on your phone, and ask for answers in simple words. The alert is about a very rare event, so most patients will never need these answers, but they cost nothing to ask.
- Which exact mesalazine product do I take, and what is its generic name?
- Have I ever had high pressure in the head, or an eye problem?
- Which symptoms should make me call you the same day?
- Whom do I call at night or on a holiday?
Keep your old prescriptions and test reports in one folder. If you change hospitals, show the folder. A new doctor then sees the full history and can judge a new headache correctly. Colitis treatment often runs for years, so this small habit saves time later.
Report the reaction so DRAP can count it
DRAP asks patients and doctors to report reactions through its Med Vigilance e-reporting system or the VigiMobile app. The National Pharmacovigilance Centre can be reached on 051 9255981 or npc@dra.gov.pk. Have the medicine name, dates and symptoms ready.
The full method is in how to report a medicine side effect to DRAP. A report does not blame your doctor. It helps the regulator see patterns.
DRAP has issued other recent alerts of the same kind. One covers sudden vision loss with semaglutide. Reading each one separately is better than assuming they apply to every medicine you take.
Common questions
Is mesalazine banned or recalled in Pakistan?
No. The alert is a warning and a label update. DRAP says the benefit and risk balance in approved uses is unchanged.
What is idiopathic intracranial hypertension?
It is raised pressure inside the skull with no clear cause. It can cause headaches, vision changes and ringing in the ears.
How common is it?
DRAP calls it very rare and lists the frequency as "not known". The alert gives no Pakistan figure and we could not find one.
Should I stop my tablets if I get a headache?
Do not stop alone. Call your doctor and describe the headache. The doctor decides whether to change treatment.
Does the alert apply to every mesalazine brand?
Yes. DRAP says all mesalazine-containing medicines in Pakistan must carry the updated warning.
What if I already had IIH before?
The alert advises caution for patients with diagnosed or suspected IIH. Tell your prescriber about that history.
How we verified this
What we checked, where we read it, and what we could not confirm.
We read DRAP Safety Alert No. 61 dated 30 January 2026 on 13 October 2026. This is a summary of the alert and not medical advice.
About the author
Public Services and Education Journalist
Fajr Riaz is a journalist and content writer at Pakistan Era, based in Lahore. She covers the questions people meet in everyday life in Pakistan: how a public service works, what a change in the rules means, and where to find a reliable answer.
