Unethical promotion of syrup puts patient safety at risk, warns DRAP

ISLAMABAD: A heated controversy has erupted over the marketing of Sildenafil syrup, with healthcare professionals and officials from the Drug Regulatory Authority of Pakistan (DRAP) condemning the pharmaceutical companies promoting the drug through advertisements.

Originally registered for the treatment of pulmonary hypertension in children, Sildenafil syrup is now at the center of an ethical debate due to its off-label use in treating erectile dysfunction.

Sildenafil is globally recognised for treating erectile dysfunction, but its tablets are not registered in Pakistan. Recently, DRAP approved the manufacturing of Sildenafil syrup solely for managing pulmonary hypertension in children — a rare and serious condition. However, pharmaceutical companies have launched an aggressive advertising campaign that many see as an attempt to promote its off-label use.

DRAP officials have expressed grave concerns over the advertising tactics, terming them “unethical marketing.” A senior DRAP official, speaking anonymously, warned, “The way Sildenafil syrup is being advertised is unethical and against the rules. This amounts to promoting the off-label use of this drug, which has only been approved for pediatric use to treat pulmonary hypertension.”

The official further pointed out the potential risks of the drug being misused. “There’s a high chance that it will be sold without prescription and used by individuals for erectile dysfunction. Adults may overdose on the syrup to achieve desired effects, which could result in severe health complications,” the official cautioned.

Another contentious issue is the alleged distribution of Sildenafil syrup to pharmacies and medical stores on a consignment basis, with payments deferred until the product is sold. This tactic, according to DRAP officials, is aimed at incentivising pharmacists to promote the syrup’s off-label use.

“We have directed drug inspectors to monitor pharmacies. Any store selling the syrup without a prescription from a qualified pediatrician or pediatric cardiologist will face strict action,” the DRAP official said. Furthermore, DRAP’s legal team is considering punitive measures against companies promoting the drug in mainstream media, which violates regulatory guidelines. Despite the absence of officially registered Sildenafil tablets in Pakistan, millions of smuggled tablets are widely available in the local market. This unregulated availability exacerbates the misuse of the drug, creating a parallel market that remains outside DRAP’s control.

The DRAP official hinted at a resolution in the near future, saying, “DRAP’s Policy Board has directed DRAP to approve drugs for treatment of ED for local manufacturing and these cases will be considered by RB once complete applications will be submitted by the companies.” Healthcare professionals have also criticised the advertisement campaign. According to pediatricians and pediatric cardiologists, the number of children needing Sildenafil for pulmonary hypertension is minimal — around 10,000 cases nationwide. Yet the aggressive marketing suggests a much larger demand, misleading the public. “This campaign is misleading and dangerous,” said a pediatric cardiologist from a leading hospital in Karachi. “Pulmonary hypertension in children is a rare condition, but these advertisements make it seem as though millions of people require the drug.”

Dr Saad Ahmed, a pediatrician based in Lahore, added, “There is a real danger that the syrup will be misused. Overdosing or improper use can lead to severe side effects, including cardiovascular complications.”

Experts have called for tighter regulations to prevent misuse and ensure that the drug is prescribed only for its intended purpose. “Public awareness is crucial. People must understand that self-medication, especially for serious conditions like erectile dysfunction or pulmonary hypertension, can have fatal consequences,” Dr Ahmed said.

As the controversy unfolds, DRAP has vowed to take immediate action to curb unethical practices and safeguard public health. While Sildenafil syrup holds promise for children suffering from pulmonary hypertension, its misuse poses significant risks that authorities must address urgently.